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On Sep 2018




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On Sep 2018




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"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."



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Lucknow
On Sep 2018




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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.
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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.


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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.
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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.
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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

Original article / research
Year : 2024 | Month : March | Volume : 18 | Issue : 3 | Page : OC19 - OC23 Full Version

Comparison of Nisha-amalaki and Metformin in Overweight and Obese Patients with Type 2 Diabetes Mellitus (Madhumeha): A Randomised Controlled Trial


Published: March 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/67643.19256
Aman Chhabra, Vaishali Kuchewar, Twinkle Joshi

1. Postgraduate Scholar, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 2. Professor, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 3. Postgraduate Scholar, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India.

Correspondence Address :
Dr. Aman Chhabra,
Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Wardha-442001, Maharashtra, India.
E-mail: chhabra.aman10@gmail.com

Abstract

Introduction: Type 2 Diabetes Mellitus (T2DM) is considered a metabolic syndrome marked by an increase in blood sugar level brought on by absolute or relative insulin deficiency, insulin resistance, or both. It was predicted that 171 million individuals would develop type 2 diabetes at the turn of the century; by 2030, this figure is expected to reach 360 million. Nisha-amalaki is a commonly used medication for Type 2 Diabetes Mellitus, and its ingredients are also routinely used worldwide. There are numerous studies on Nisha-amalaki showing its antidiabetic effect, but it has not been studied in overweight and obese Type 2 diabetic patients; hence, present study is planned.

Aim: To compare the efficacy of Nisha-amalaki and Metformin in overweight and obese patients with Type 2 Diabetes Mellitus.

Materials and Methods: The present was a parallel-group, single-blind, randomised, standard controlled trial conducted in the Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. The trial included a 60-day treatment period and a follow-up period every 15 days. The study comprised a total of 60 overweight and obese patients suffering from Madhumeha, randomly divided into two equal groups. Group N (experimental group) was treated with 6 gm Nisha-amalaki Churna two times a day before meals with lukewarm water, and Group M (control group) was treated with 1 gm Tablet Metformin administered twice a day before meals in equal divided doses for 60 days. Patients were assessed for objective parameters like Fasting Blood Sugar (FBS) level, Post Meal Blood Sugar (PMBS) level, and Body Mass Index (BMI) at the start and end of the study. Statistical analysis was done by assessing through paired and unpaired t-tests and compared with the help of Z-test.

Results: Madhumeha is more prevalent in the 51-60 years age group as well as in males compared to females. The mean FBS level before treatment was 151.98 mg/dL and 143.08 mg/dL in Group M and Group N, respectively, which significantly reduced to 138.56 mg/dL and 129.39 mg/dL after treatment. The mean PMBS level before treatment was 232.45 mg/dL and 223.56 mg/dL in Group M and Group N, respectively, which reduced to 230.35 mg/dL and 209.26 mg/dL after treatment. The mean BMI before treatment was 26.49 mg/dL and 26.06 mg/dL in Group M and Group N, respectively, which reduced to 26.23 mg/dL and 25.86 mg/dL after treatment. Both the groups (standard as well as the trial group) are equally effective in reducing FBS level. During the follow-up visits, no adverse effects or side effects were observed in any patient.

Conclusion: Both Nisha-amalaki Churna and Tablet Metformin are equally effective in reducing FBS level. Nisha-amalaki has a better effect compared to Metformin in reducing PMBS level. Metformin has a better effect compared to Nisha-amalaki in reducing BMI. So, it can be concluded that Nisha-amalaki Churna is as effective as Tablet Metformin in the management of overweight and obese patients suffering from Type 2 Diabetes Mellitus.

Keywords

Churna, Fasting blood sugar level, Post meal blood sugar level

Type 2 Diabetes Mellitus is considered a metabolic syndrome marked by an increase in blood sugar level brought on by absolute or relative insulin deficiency, insulin resistance, or both (1). In developing and middle-income nations like India, type 2 diabetes mellitus is a potentially epidemic health problem that is growing rapidly. By 2025, estimates indicate that there will be 69.9 million cases of diabetes in India, the vast majority of which will remain untreated (2). It was predicted that 171 million individuals would develop type 2 diabetes at the turn of the century; by 2030, this figure is expected to reach 360 million (3).

Metformin has been the drug of choice for disorders related to Type 2 Diabetes Mellitus, overweight, and age-related disorders due to its excellent tolerability, safety profile, and efficacy in decreasing blood sugar levels (4). In the classical texts of Ayurveda, out of the twenty types of Prameha, the clinical features of Madhumeha are matchable with Type 2 Diabetes Mellitus. Therefore, Madhumeha can be correlated with Type 2 Diabetes Mellitus (5).

Nisha-amalaki is one of the common medicines mentioned in various Samhitas for the management of Madhumeha, namely Charak, Vagbhat, and Sushrut (6),(7),(8). It is needed to explore safer medicine. Nisha-amalaki is a commonly used medication for Type 2 Diabetes Mellitus, and its ingredients are also in routine use worldwide. There are numerous studies on Nisha-amalaki showing its antidiabetic effect, but it has not been studied in overweight and obese Type 2 diabetic patients; hence, present study was planned (9),(10),(11). The research protocol for present study has already been published (12).

The aim of present study was to compare the efficacy of Nisha-amalaki and Metformin in overweight and obese patients with Type 2 Diabetes Mellitus.

Material and Methods

A parallel-group, single-blind, randomised standard controlled trial was conducted with patients who visited the Outpatient and Inpatient Departments of the Kayachikitsa Department, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India as well as those from specialty camps, registered for the present study over a duration of two years and six months. The study was completed in June 2023. Approval was obtained from the Institutional Ethics Committee (Ref no. MGACHRC/IEC/July- 2021/331). The study was started after registration with CTRI (Reg. no. Clinical Trail Registry (CTRI)/2021/10/037263). Before the commencement of the study, written informed consent was taken from each patient.

Inclusion criteria: Patients aged between 30 to 60 years of either gender, with FBS Level more than 126 mg/dL and/or postprandial blood sugar level more than 200 mg/dL, and BMI between 25-30 kg/m2 (13).

Exclusion criteria: Patients with FBS level more than 200 mg/dL, postprandial blood sugar level more than 300 mg/dL, pregnant and lactating women, patients with acute complications like cirrhosis of the liver, pancreatitis, and hypoglycaemic shock, and those with chronic complications like nephropathy, retinopathy, and neuropathy were excluded from the study.

Sample size calculation: The sample size was calculated by software and master 2.0. There were two proportions; Hypothesis testing-large population and in equal allocation. Proportion in group M was 0.85, proportion in group M was 0.5483. The risk difference=0.3017, power (%)=80, alpha error (%)=5, side=2 and required sample size for each group was 27.

Dropout–10% thus By considering 10% dropout rate.

Sample size×Dropout factor=Total number of patients to be taken 27×1.11=30 patients.

Each group had 30 patients.

Total sample size was of 60 patients.

Study Procedure

In present trial, a total of 60 patients were chosen for the research, divided into two equal groups of 30 patients each. Participants met the criteria for randomisation and were assigned to the experimental and control groups in a 1:1 ratio. A lottery method of randomisation mechanism provided researchers with access to the treatment allocation for each eligible participant, ensuring that the patients were kept blinded.

Group N was the experimental group, whereas Group M was the standard controlled group. The objective parameters studied in the trial include FBS level, PMBS level, and BMI before starting and at the end of the study.

Primary outcomes with significant improvement was seen in both groups in reducing the objective parameters, including FBS levels, PMBS levels, and BMI in overweight and obese patients suffering from Type 2 Diabetes Mellitus (Madhumeha).

Secondary outcomes with no adverse effects of the trial drug were observed in any patients enrolled in present study.

The grouping and posology for Nisha-amalaki Churna and Tablet Metformin are mentioned (Table/Fig 1) [14,15]. The Consodilated Standards of Reporting Trails (CONSORT) has been depicted in (Table/Fig 2).

Statistical Analysis

A type I error level of 5% (two-sided) will be regarded statistically significant. Intention-to-treat and per-protocol populations will be used in the analysis. For each group, baseline characteristics were offered, as well as predicting factors. Paired and unpaired t-tests will be performed to assess the data at each time point for comparisons between the experimental and control groups. The univariate analysis is the initial phase. Data with a normal distribution will be analysed using paired and unpaired t-tests. Patients were followed-up at day 0, day 15, day 30, day 45, and day 60. Objective parameters were assessed after completion of treatment, and the data were statistically analysed using descriptive and inferential statistics, the student’s paired t-test, and z-proportion test. A p-value of <0.05 is considered statistically significant.

Results

The age-wise distribution of subjects in both groups is provided in (Table/Fig 3). Out of 60 subjects, 33 (55.4%) were aged between 51-60 years, 23 (38.3%) were aged between 41-50 years, and 4 (6.7%) were aged between 31-40 years. The gender-wise distribution of subjects in both groups is detailed in (Table/Fig 4). In present study, the gender wise distribution showed that out of 60 subjects, 33 (55.0%) were males, and 27 (45.0%) were females.

The distribution of subjects according to the exercise pattern in both groups is mentioned (Table/Fig 5). It was observed that out of 60 subjects, 47 (78.3%) were not exercising at all, and 13 (21.7%) were exercising regularly.

The comparison of mean FBS level before and after treatment in both groups is mentioned (Table/Fig 6). In Group M, the mean FBS level before treatment was 151.98±27.442 mg/dL, which significantly reduced to 138.56±24.948 mg/dL after treatment with t and p-values of (2.801, p=0.009, S). In Group N, the mean FBS level before treatment was 143.08±24.646 mg/dL, which reduced to 129.39±27.173 mg/dL after treatment, and this reduction was statistically significant with t and p-values of (2.854, p=0.008, S).

When comparing both groups using the Z-proportion test, the z-value was -1.084, and the p-value was 0.280, indicating a non significant difference in the % change of FBS, suggesting that both groups are equally effective in reducing FBS levels.

The comparison of mean PMBS level before and after treatment in both groups is detailed in (Table/Fig 7).

In Group M, the mean PMBS level before treatment was 232.45±41.609, which reduced to 230.35±46.022 after treatment; this change was statistically non significant with t and p-values of (0.291, p=0.773, S). In Group N, the mean PMBS level before treatment was 223.56±51.838, which reduced to 209.26±57.886 after treatment; this reduction was also statistically non significant with t and p-values of (1.729, p=0.094, S).

When comparing both groups using the Z-proportion test, the z-value was -4.155, and the p-value was 0.001, indicating a significant difference in the % change of PMBS. This suggests that Nisha-amalaki has a better effect compared to Metformin in reducing PMBS levels.

In Group M, the BMI before treatment was 26.49±0.900, which reduced to 26.23±0.899 after treatment; this change was statistically significant with t and p-values of (15.661, p=0.001, S). In Group N, the BMI before treatment was 26.06±0.826, which reduced to 25.86±0.804 after treatment; this reduction was also statistically significant with t and p-values of (15.314, p=0.001, S).

When comparing both groups using the Z-proportion test, the z-value was 2.459, and the p-value was 0.013, revealing a significant difference in the % change of BMI. This means that Metformin has a better effect compared to Nisha-amalaki in reducing BMI (Table/Fig 8).

Discussion

According to demographic statistics, Diabetes Mellitus is most common in the age group of 51 to 60 years. The percentage of females and males affected by Madhumeha is 45% and 55%, respectively. It is worth mentioning that Madhumeha can affect individuals of any gender; however, due to their stressful and sedentary lifestyles, males may experience it more frequently. Previous research investigations by Deshpande S et al., and Kundu S et al., have indicated that the incidence of the disease is higher in age groups between 40 and 60 years (16),(17). The present data clearly shows that the condition is common among elderly people. The cause could be attributed to factors such as stress, addiction, poor eating habits, and a sedentary lifestyle (18).

Other research studies (19),(20),(21),(22) found a higher prevalence of the disease in males in their studies, revealing that Diabetes was present in 34 individuals (5%; 20 men and 14 women) and impaired glucose tolerance in 15 individuals (2%; eight men and seven women). Thus, a total of 49 individuals (7%) had abnormal glucose tolerance. Total 13 of those with diabetes were receiving treatment. Gender differences arising from psychosocial and cultural processes, such as different behaviours, lifestyles, and attitudes towards prevention and treatment, also impact the susceptibility and progression of Type-2 diabetes.

In present study, 78.3% of patients were found to be suffering from Type-2 Diabetes Mellitus and were not exercising, whereas only 21.7% of patients had a history of regular exercise. This clearly indicates that regular exercise plays a role in the occurrence of Type-2 Diabetes Mellitus. Research conducted by Joseph JJ et al., showed that the incidence of Type-2 Diabetes Mellitus in patients who do not exercise is higher than in those who do regular exercise (23).

The mean FBS level before treatment was 151.98 and 143.08 in Group M and Group N, respectively, which significantly reduced to 138.56 and 129.39 after treatment. This depicts that both Nisha-amalaki Churna and Tablet Metformin are equally effective in reducing FBS levels. The mean PMBS level before treatment was 232.45 and 223.56 in Group M and Group N, respectively, which reduced to 230.35 and 209.26 after treatment. This depicts that Nisha-amalaki Churna is more effective than Tablet Metformin in reducing PMBS levels. The mean BMI before treatment was 26.49 and 26.06 in Group M and Group N, respectively, which reduced to 26.23 and 25.86 after treatment. This reveals that Metformin is more effective than Nisha-amalaki in reducing BMI.

The animal study conducted by Bedarkar P (24) showed that at dose levels of 90 and 180 mg/kg, Nishamalaki Churna (fine powder of Curcuma longa and Emblica officinalis 1:1) significantly decreased (p<0.05-0.01) hyperglycemia compared to the glucose-treated group (25). When compared to the normal group’s animals, the glucose control group’s animals displayed a substantial (p<0.01) rise in glucose levels following 30 minutes of glucose delivery. Nishamalaki Churna has a hypoglycaemic impact comparable to that of regular metformin.

A clinical trial on Nisha-amalaki in the management of Madhumeha vis-à-vis diabetes mellitus was conducted by Yadav RK (25) revealing that the medication Nishamalaki appears to be a risk-free and economical treatment for Diabetes mellitus. It might not be as helpful for people whose FBS levels are higher than 200 mg%. An oral hypoglycaemic medication may be added in such a situation. Due to its superior safety profile, this medication can be used in conjunction with current oral hypoglycaemic medicines as an adjuvant.

A study conducted by Rao G demonstrated that diabetic rats treated with Nishamalaki had significantly lower plasma glucose levels than those treated with Troglitazone (26). In one animal study, Nisha-amalaki Churna was also found to be a weight-reducing agent (27). In a study conducted by Yadav KD, Chaudhary AK, it was revealed that Turmeric has anti-inflammatory and antioxidant properties, boosts adiponectin concentration, and keeps the balance of nutritional components, genetic points, and therefore might be advantageous for the management of obesity (28).

Probable mode of action of Nisha-amalaki: Nisha-amalaki contains Haridra (Curcuma longa L) and Amalaki (Emblica officinalis Gareth). In experimental animal models, its rhizomes were shown to exhibit antidiabetic characteristics. Curcumin, the key component, was shown to have antidiabetic properties, according to researchers (29).

Haridra’s Veerya (potency) is Ushna and has Tikta Rasa, both of which are advantageous in Kaphaja Vikaras. These drugs have properties like Ruksha, Ushna, Tikshna, and Katu Vipaka that help with Samprapti Vighatana (pathogenesis) and so aid in the treatment of Type-2 Diabetes Mellitus patients (30). A study conducted by Maithili N et al., revealed that turmeric may be added as an adjuvant to antihyperglycemic medication in order to avoid or delay Type-2 DM molecular consequences. Consequently, turmeric helps to maintain normoglycemic status and prevent the emergence of complications (31). A study conducted by Zinjarde SS et al., showed that the enzyme Human Pancreatic Amylase (HPA) was most effectively inhibited by the Curcuma longa isopropanol and acetone extracts. Less starch hydrolysis due to this HPA suppression reduces blood glucose levels (32).

In a systematic review conducted by Zhang D-W it was studied that most of the main hallmarks of diabetes, including insulin resistance, hyperglycemia, hyperlipidemia, and islet apoptosis and necrosis, may be positively impacted by Curcumin (the main constituent of Turmeric). Curcumin also has the potential to prevent the negative effects of diabetes complications (33). In a study conducted by Ghorbani Z et al., it was revealed that by decreasing hepatic glucose production and glycogen synthesis and stimulating glucose uptake, Curcumin can lower blood sugar and HbA1c levels. This is accomplished by suppressing hyperglycemia-induced insulin resistance (34).

Ellagic acid in Emblica officinalis exhibits antidiabetic effects by stimulating insulin production and decreasing glucose intolerance in diabetic rats. Immunohistochemistry of the pancreas revealed that Emblica officinalis boosted Beta cell size and number in diabetic rats. It also increased glucose-stimulated insulin production from isolated islets and reduced glucose intolerance in diabetic rats (35). Amalaki (Emblica officinalis) is mostly composed of alkaloids, phenolic chemicals, amino acids, and carbohydrates. In a study conducted by Muruhananthan G et al., it was revealed that in tests using the Oral Glucose Tolerance Test (OGTT) and herbal preparations made with Emblica officinalis extract on normal and diabetic rats, there was a significant, minimal, and very slight decrease in blood glucose levels (36).

As Madhumeha is Kaphjanya Vikar, due to the Ushna and Tikshna properties of Haridra and Amalaki, they act on Kapha dosha to decrease it and thereby aid in the management of Madhumeha (37).

Limitation(s)

Limitation of the present study was that the Glycosylated Haemoglobin (HbAIC) was not assessed to evaluate the efficacy of the trial drug on sugar control.

Conclusion

Madhumeha is more prevalent in the 51-60 years age group, as well as in males compared to females. Patients who do not exercise were found to have more incidence of Type-2 Diabetes Mellitus. Upon comparing both groups, a non significant difference in the % change of FBS suggests that both groups are equally effective in reducing FBS levels. Nisha-amalaki has a better effect compared to Metformin in reducing PMBS levels, while Metformin has a better effect compared to Nisha-amalaki in reducing BMI. Nisha-amalaki Churna is found to be equally effective in overweight and obese diabetic patients. Nisha-amalaki (a combination of daily use herbs Haridra and Amalaki) is effective in normalising blood sugar levels for patients with FBS in the range of 126-200 mg/dL and PMBS in the range of 200-300 mg/dL, with a BMI range of 25-30 kg/m2.

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DOI and Others

DOI: 10.7860/JCDR/2024/67643.19256

Date of Submission: Sep 21, 2023
Date of Peer Review: Dec 19, 2023
Date of Acceptance: Jan 22, 2024
Date of Publishing: Mar 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: Sep 23, 2023
• Manual Googling: Dec 22, 2023
• iThenticate Software: Jan 20, 2024 (9%)

ETYMOLOGY: Author Origin

EMENDATIONS: 8

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