Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Research Protocol
Year : 2024 | Month : February | Volume : 18 | Issue : 2 | Page : RK01 - RK04 Full Version

Comparative Evaluation of the Efficacy of Shallakyadi Plaster and Standard POP in the Management of Simple Fractures of Long Bones of the Upper Limb: A Research Protocol


Published: February 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/66590.19009
GV Pavithra Jaivarshaa, Devyani Dasar

1. Postgraduate Scholar, Department of Shalyatantra, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India. 2. Associate Professor, Department of Shalyatantra, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.

Correspondence Address :
Dr. GV Pavithra Jaivarshaa,
Postgraduate Scholar, Department of Shalyatantra, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha-442001, Maharashtra, India.
E-mail: pavithra.jv.gv@gmail.com

Abstract

Introduction: Fracture management is one of the well-established concepts in Ayurveda with numerous fracture healing drugs mentioned for topical application. The present study is an attempt to form a compound of few of those drugs which can be used as a plaster cast. The effect of this Herbomineral ayurvedic plaster cast on fractures would be studied both in aspects of immobilisation and fracture healing. Shallakyadi plaster which is a novel compound composed of resin of Boswellia serrata Roxb, resin of Acacia nilotica (Linn.) Willd.ex Del, root of Glycirrhiza glabra Linn, whole plant of Cissus quadrangularis Linn, Stem of Rubia cordifolia Linn, bark of Terminalia arjuna Wight & Arn (W&A), resin of Commiphorawightii Arn, Kaolinite (phyllosilicate of aluminium) and hydrated magnesium silicate can be used as a herbomineral ayurvedic compound for the healing of fractures.

Need of the study: Standard Plaster of Paris (POP) cast has no therapeutic role on healing of fracture other than the purpose of immobilisation, whereas the drugs in Shallakyadi Plaster have known effects on bone healing and also provide the adequate immobilisation provided by Standard POP cast. Hence, the present study will compare the efficacy of Shallakyadi Plaster and Standard POP in the management of simple fractures of long bones of upper limb.

Aim: To study and compare the efficacy of Shallakyadi plaster and standard POP in the management of simple fractures of long bones of upper limb.

Materials and Methods: The present study is designed as a randomised control trial which would be conducted in Mahatma Gandhi Ayurveda College Hospital and Research Centre (MGACHRC), Salod Hirapur (H), Maharashtra, India for three months, in which 60 patients will be enrolled. Standard POP Plaster or Shallakyadi plaster will be applied for local application over the fractured area. Parameters like pain, swelling, loss of function, tenderness would be studied subjectively and callus formation would be taken as the objective parameter. Statistical analysis would be done using GraphPad Prism 7.0 V software and statistical tests- Chi-square test, Wilcoxon’s rank sum test and Wilcoxon’s signed rank test will be applied with level of significance as 0.05.

Keywords

Fracture, Herbomineral plaster, Orthopaedic cast, Plaster of paris, Shallakyadi cast, Sushruta

Management of traumatic fractures has seen endless advancements in this modern world, with the invention of imaging techniques like X-ray, techniques such as open reduction, fixation of dynamic screws and inert wires, replacement, grafting with modern surgical tools, and the usage of plasters, fibreglass casts, and lighter splints for non surgical management (1). The total incidence of fractures per 100,000 people per year was 406. The overall incidence of lower limb fractures is 247, whereas the overall incidence of upper limb fractures is 159 (2).

In spite of the recent advances, the basics of fracture management such as reduction, immobilisation, and rehabilitation can be traced back to the management protocols of Sushruta. Acharyas have mentioned various drugs that help in the healing of fractures and also provide symptomatic relief from pain and swelling (3). Charaka has mentioned Sandhaneeya Dashemani (4). Susrutha has mentioned Priyangu-Ambastadhigana, Nyagrodhadhi Gana (5), and various Nighantu quotes and many Asthi Sandhanakara Dravyas. For fracture management, reduction and immobilisation are universally required and should be done according to prescribed standard protocols.

In the treatment of fractures, anatomical union is not only the ultimate aim, but attention must also be paid to avoid or minimise the forthcoming complications such as scaling, ulceration, maceration, itching, and burns due to exothermic reactions. The underlying skin is prone to Staphylococcus-induced dermatitis. However, the toughest complication is compartment syndrome and the resulting sequelae of Volkmann’s ischaemic contracture (6).

For this purpose, the role of indigenous drugs in fracture healing is continuously under scrutiny by scientists for their mechanism of action. According to reviews, the interest and curiosity of many research scholars have been focused on the oral use of various indigenous drugs and local applications for fracture healing agents. After a thorough review of previous work done by different scholars, it was observed that little emphasis is given to the combined use of local and systemic drugs. Most of the time, surgeons face problems with simple fractures of the hand, wrist, ankle, foot, etc., not due to the fracture itself, but due to immobilisation with standard POP (7).

Considering the high incidence of this type of fractures occurring in day-to-day life and the resulting complications with POP, it was decided to undertake the present study. The existing plaster casts do not have any local therapeutic effects and only work for immobilisation (8). Existing Ayurvedic medicines work as local application agents and do not serve the purpose of immobilisation for which splints are used externally. Lakshadi Plaster is an existing Ayurvedic plaster that acts as a cast and helps in fracture healing, but no further studies have been conducted on the properties of this plaster (9). This herbomineral plaster comprises natural resins such as Boswellia Serrata Roxb, Acacia arabica Wild.var. indica Benth, Commiphora wightii Arn, along with the roots of Glycyrrhiza glabra Linn, the whole plant of Cissus quadrangularis Linn, the roots of Rubia cordifolia Linn, the bark of Terminalia arjuna W&A, as well as Kaolinite clay and hydrated magnesium silicate. All these drugs are already known as fracture healing agents in Ayurvedic literature, and the natural resins help achieve the desired plaster cast form (10),(11). Hence, the present study aims to find the efficacy of Shallakyadi Plaster when compared with Standard POP plastering in the management of simple fractures of long bones of the upper limb.

The objectives include:

1. To study the efficacy of Shallakyadi Plaster on pain, swelling, loss of function, and tenderness, which are taken as subjective parameters, and callus formation, which is taken as an objective parameter in simple fractures of long bones of the upper limb.

2. To study the efficacy of standard POP on pain, swelling, loss of function, and tenderness, which are taken as subjective parameters, and callus formation, which is taken as an objective parameter in simple fractures of long bones of the upper limb.

3. To compare the efficacy of Shallakyadi plaster and standard POP in the management of simple fractures of long bones of the upper limb.

Null hypothesis (H0): Shallakyadi Plaster is not efficacious as standard POP in the management of simple fractures of long bones of the upper limb.

Alternate hypothesis (H1): Shallakyadi Plaster is more efficacious than standard POP in the management of simple fractures of long bones of the upper limb.

Alternate hypothesis (H2): Shallakyadi Plaster is equally efficacious as standard POP in the management of simple fractures of long bones of the upper limb.

Review Of Literature

Despite recent advances, the contemporary management of simple fractures remains similar to Sushruta’s technique, which involves Anchana, Peedana, Samkshepana, and Bandhana. Along with various procedures, many drugs have been mentioned to possess bone-healing properties. In the present study, Sushruta’s technique and these drugs have been used in the management of fractures to assess their efficacy in bone healing and providing symptomatic relief. The management of simple closed fractures with closed reduction is followed by the application of a cast or splint, POP plastering, and physiotherapy after the period of immobilisation and removal of plasters or casts. This approach focuses on the main principles of reduction, immobilisation, and rehabilitation. POP plastering aligns with the basic principle of immobilisation.

The gum resin of Shallaki has potent anti-inflammatory action due to its active ingredients α and β boswellic acid and other pentacyclic triterpenic acids, which affect 5-lipoxygenase, cyclooxygenase, and the complement system. Acetyl-11-keto-β-boswellic acid proves to be a potent inhibitor of 5-lipoxygenase (7),(12). Both Guggulu and the methanol extract of C. mukul are found to have Shothahara (anti-inflammatory) and Bhagna Sandhankara (fracture healing) properties. The inhibition of bone loss occurs by suppressing osteoclastic activity, either by suppression of NF-κB activation or by other antioxidant mechanisms promoting bone mineralisation (9),(13). Yastimadhu, mentioned as Sandhaneeya by both Susrutha and Charaka, has anti-inflammatory and analgesic properties. Glycyrrhetic acid, liquiritoside, and Licochalcone exhibit significant anti-inflammatory properties, while flavonoids such as Isoliquiritigenin exhibit analgesic activity (14). Asthishrinkala, known as Hadjod, has anti-inflammatory, analgesic, and antipyretic activities, and contains natural steroids and vitamins that are useful for early bone healing (15). External application facilitates rapid healing (16). Manjista is known to have anti-inflammatory, haemostatic, antipyretic, and analgesic properties (17). It is Rakta Prasadaka and Ushna Veerya, due to which it will increase peripheral arterial blood flow. The Kapha-pitta Shamaka property will reduce the local oedematous residue, and its Ushna Veerya property helps penetrate into local tissue. The calcium salts, gum, resinous matter, and its properties initiate early callus formation (18). Arjuna bark contains calcium carbonate (34%), other calcium salts (9%), and tannin (16%). Besides, it also contains aluminium, magnesium, organic acid, colouring matter, and sugar, and is highly potent in promoting the healing of broken bones (19),(20). Dughdhapashana and Shuddha Khatika aid in the development of plaster and play an important function in reducing pain and swelling (21),(22). Baboola is used for enhancing fracture healing and is bhagnasandhanakara. Babool resin has almost 52% calcium with magnesium, galactose, and other active principles. It causes an increase in osteoblast differentiation and a reduction in osteoclast activity, promoting more cell proliferation and significantly increased mineralisation of bone-like matrix (23),(24).

Methodology

The randomised controlled trial will be conducted at Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod (H). The total study period will be three months, including the follow-up period. The study has obtained ethical clearance from the Institutional Ethical Committee of DMIMS, Wardha, Maharashtra, India, numbered as MGACHRC/IEC/July-2021/343. The Clinical Trials Registry-India (CTRI) registration number is CTRI/2021/12/038784. The study will commence after obtaining informed written consent from the patients.

Sample size calculation: The Cochran formula was used for sample size estimation, with a confidence level of 1.96 and a margin of error of 0.10, resulting in a fixed sample size of 30 in each group. Patients were equally allocated to two groups using a computer-generated randomised table method. Blinding/masking was not performed in the present study, as the application of plaster cannot be blinded.

Inclusion criteria: Patients aged 10 to 50 years will be enrolled after obtaining written informed consent. Patients with clinical features of traumatic simple fractures of long bones of the upper limb will be included after screening. Patients of any gender, occupation, or economic status will be included.

Exclusion criteria: Patients with systemic disorders such as diabetes mellitus, tuberculosis, Human Immunodeficiency Virus (HIV), hepatitis, and renal diseases will be excluded. Open fractures, multiple, compound, or comminuted fractures, as well as fractures other than those in the upper limbs, will be excluded. Patients with nerve and vessel injuries and those with bone infective diseases such as osteomyelitis and TB will be excluded. Additionally, patients below 10 years of age and above 50 years of age will be excluded.

Preparation of Shallakyadi Plaster

Purification (Shodanam) of drugs: Glycyrrhiza glabra Linn, Rubia cordifolia Linn, Cissus quadrangularis Linn, and Terminalia arjuna W&A will be washed and cleaned thoroughly. These herbal drugs do not require any specific purification before formulating for external application.

Preparation of (kashaya) decoction: Coarse powders of Glycyrrhiza glabra Linn, Rubia cordifolia Linn, and Terminalia arjuna W&A will be taken in equal quantity (1 kg each) and soaked in sufficient water overnight (for 12-16 hours). One kg of crushed whole plant of Cissus quadrangularis Linn will be soaked in sufficient water for 4-8 hours. Then these will be added together and boiled with 64 L of water. Once the mixture starts boiling, maintain the temperature around 60-120 degrees Celsius and reduce it to 1/4th (around 15 L to 17 L). The obtained kashayam will be filtered with white muslin cotton cloth.

Preparation of fine churna (powder): Fine powder of all the resins will be made and sieved through sieve number No. 85/100/120 (IS 460-1978) individually.

Preparation of Shallakyadi gauze roller bandages: Fine powder of shodita (purified) resin of Commiphora wightii Arn and resin of Boswellia serrata Roxb, resin of Acacia nilotica (Linn.) Willd. ex Del followed by fine powders of Kaolinite (phyllosilicate of aluminum) and hydrated magnesium silicate will be added in equal ratios to a quantity sufficient amount of decoction made in step 1. It will be mixed and dissolved completely. Gauze roller bandages of 4 inches (2.7 m long), 6 inches (2.7 m long), and 2 inches (2.7 cm long) will be soaked in this paste for 5-30 minutes, impregnated with the paste and dried. (An air blower can be used)

Application of Shallakyadi cast/slab:

i. Soft cotton padding is applied circumferentially over the fractured limb, extended as the nature and site of the fracture require.

ii. Applied as either Shallakyadi cast/slab after the reduction of the fracture.

Diagnosed patients of simple fractures of long bones of the upper limb will be enrolled in the present study after fulfilling the inclusion criteria. A total of 30 patients will be divided into two groups, where Group A patients will be treated with Shallakyadi Plaster cast, and Group B will be treated with the standard POP plaster cast for a period of 56 days according to the type of fracture. Follow-up will be done on the 63rd and 84th days (Table/Fig 1). The following table shows the intervention (Table/Fig 2).

Assessment Criteria

The following subjective and objective parameters will be assessed.

Subjective Parameters

Acute Pain-Weekly assessment will be conducted.

G0- No pain, G1- Mild pain without difficulty in working, G2- Moderate pain with severe difficulty in working, and G3- Severe pain making working impossible.

Acute Swelling (assessed by measuring the circumference of the fractured limb compared to the normal limb)-will be assessed before applying the slab/cast and after the removal of the slab/cast.

G0- No swelling, G1- Mild: Girth increased up to 2 cm, G2- Moderate: Girth increased 2-6 cm, G3- Severe: Girth increased by more than 6 cm.

Acute Tenderness (initial assessment elicited by palpating the fractured site, subsequent assessments by springing test)-will be assessed before applying the slab/cast and after the removal of the slab/cast.

G0- Tenderness absent, G1- Patient winces with pain, G2- Patient winces and withdraws the affected part, G3- Patient does not allow touching the affected part.

Acute Loss of function-will be assessed before applying the slab/cast and after the removal of the slab/cast.

G0- Proper function of bones and joints, G1- Mild pain during movement, G2- Severe pain and restricted movement, G3- Total loss of function.

Objective parameters: Callus formation (visible on X-ray) on the day of the fracture, 21 days after the fracture and cast application, and 42 days after the fracture and cast application (or other days as needed according to the case).

G0-No callus, G1-Soft callus, G2-Hard callus.

Criteria for discontinuing or modifying allocated interventions: Patients will be withdrawn from the intervention if any harmful incidents, signs of drug allergy, or any problems occur. Patients will be offered treatment free of cost until the fracture heals and local symptoms subside.

Statistical Analysis

The statistical analysis will be conducted using GraphPad Prism 7.0 software. The Chi-square test will be used for subjective parameters, while the Wilcoxon’s rank sum test will be used for the other parameters. Additionally, the Wilcoxon’s signed rank test will be used for comparisons, with a significance level set at 0.05. (Table/Fig 3) displays the Gantt chart.

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DOI and Others

DOI: 10.7860/JCDR/2024/66590.19009

Date of Submission: Jul 19, 2023
Date of Peer Review: Sep 20, 2023
Date of Acceptance: Dec 12, 2023
Date of Publishing: Feb 01, 2024

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jul 20, 2023
• Manual Googling: Sep 23, 2023
• iThenticate Software: Dec 09, 2023 (7%)

ETYMOLOGY: Author Origin

EMENDATIONS: 7

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