Year :
2025
| Month :
July
| Volume :
19
| Issue :
7
| Page :
JK01 - JK04
Full Version
Efficacy of Gunja Beeja Ointment versus Diclofenac Sodium Ointment in the Management of Avabahuka (Frozen Shoulder): A Research Protocol for a Randomised Controlled Trial
Published: July 1, 2025 | DOI: https://doi.org/10.7860/JCDR/2025/75749.21169
Shreya Parkhi, Sadhana Durgaprasad Misar
1. Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Wardha, Maharashtra, India.
2. Professor, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Wardha, Maharashtra, India.
Correspondence Address :
Shreya Parkhi,
Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Wardha-442001, Maharashtra, India.
E-mail: shreyaparkhi22@gmail.com
Abstract 
Introduction: Avabahuka, primarily caused by vitiated Vata affecting the Amsa Sandhi, manifests as shoulder dysfunction. Acharya Sushruta, categorise Avabahuka as a Vata Vyadhi, recommending Vatavyadhi Chikitsa. Symptoms include loss of upper limb movement, pain, and shoulder joint stiffness. In modern medicine, Avabahuka is analogous to Frozen Shoulder or Adhesive Capsulitis, impacting 2-5% of people in general and 10-15% of diabetics. Charaka Samhita recommends Lepa (paste) for immediate relief.
Need of the study: The modern treatment includes analgesics and local intra-articular injections of corticosteroids, and physiotherapy. Nonsteroidal anti-inflammatory drugs have side effects such as nephrotoxicity, infectious arthritis and cartilage damage. There is a need for a safe and effective Ayurvedic herbal drugs which can be beneficial in such cases. Gunja Beeja contains Abrin and Abralin that has analgesic, anti-inflammatory and antimicrobial activities. No randomised controlled trial has been conducted on Gunja Beeja ointment in Avabahuka.
Aim: To evaluate the efficacy of Gunja Beeja ointment versus diclofenac sodium ointment in the management of Avabahuka (Frozen Shoulder).
Materials and Methods: This single-blind, parallel randomised controlled trial will take place over a period of one and a half years (February 2025-January 2026) at the Mahatma Gandhi Ayurved College Hospital and Research Centre (MGACH & RC), Salod (H) Wardha, Maharashtra, India. The study registered under CTRI/2024/07/070559 involves 60 patients meeting the inclusion criteria, randomly assigned into two groups of 30 each. Group 1 will receive Diclofenac sodium ointment while Group 2 will receive Gunja Beeja Ointment with shoulder exercises in both groups, once daily for seven days. Assessments will be conducted on days 0, 7, and 14, with follow-up on day 14. Outcomes will be measured using range of shoulder movement (Goniometer), pain (Visual Analogue Scale), stiffness (scoring method), muscle atrophy (measured in centimeters), and the Disability of Arm, Shoulder, and Hand (DASH) questionnaire.
Keywords
Amsa sandhi, Adhesive capsulitis, Lepa, Vatavyadhi chikitsa
Introduction
Avabahuka is caused mainly by vitiated Vata which affects Amsa Sandhi (1). Therefore, Avabahuka means dysfunction of shoulder. Acharya Sushruta and other Acharyas considered Avabahuka as Vata Vyadhi. Madhavnidana describes two stages of Avabahuka: Amsashosha (caused by vitiated Vata) and Avabahuka (caused by vitiated Vata and dryness of Shleshak Kapha) (2). The three main characteristics of Avabahuka are-Bahupraspandidahara (difficulty or loss of movement of the upper limb), Shoola (pain) and Amsabandhana Shosha (stiffness of shoulder joint) (3). In modern science, Avabahuka is correlated with frozen shoulder or adhesive capsulitis as the pathology involves the capsule of the joint as mentioned by various researches in their study (4). It affects around 2% to 5% of the general population and 10% to 15% of those with diabetes [5,6]. Shamana Chikitsa can be given in the form of Bahya and Abhyantar chikitsa (7). In Bahya chikitsa for pain and stiffness Lepa Chikitsa with various Vatashamaka herbs is indicated for instant relief (8). Most of the studies available are on Nasya and Agnikarma but studies on Bahya Chikitsa are not conducted for Avabahuka. In Yogaratnakar Gunja Beeja Lepa is mentioned for Avabahuka Chikitsa (9). In this study Gunja Beeja Lepa is modified to ointment to increase the duration of retention and easy applicability. Gunja contains alkaloids like Abrin, Abusine, N-Methyltryptophan, glycosides like Abrusion A, Precatorine; Flavonoids like Quercetin, Kaempferol and saponins like Abrus sapogenin which shows anti-inflammatory, antioxidant and analgesic effect. It Inhibit inflammatory mediators, interact with opioid receptors for analgesia, scavenge free radicals, reducing oxidative stress, modulate immune responses, reducing inflammation and relax muscles, improving mobility (10). Diclofenac sodium ointment is a topical non-steroidal anti-inflammatory drug used to treat pain, inflammation and stiffness. But in some cases, it causes skin irritation, pruritus, burning sensation and contact dermatitis (11). Hence, there is a need of safe and effective Ayurvedic herbal drug beneficial in such cases. No randomised controlled trial has been conducted on Gunja Beeja Ointment for the treatment of Avabahuka.
Review of Literature
According to the Sushruta and Vagbhatta, Avabahuka is a Vatavyadhi, or illness brought on the vitiation of Vatadosha. Sushruta promoted adhering to Vatavyadhi Chikitsa. The Avabahuka is described by Madhavkar in the Madhav-Nidan Vatavyadhi chapter. According to Madhukosha, there are two stages of Avabahuka. Amsashosha (caused by vitiated Vata) and Avabahuka (caused by vitiated Vata and dryness of Sheshak Kapha). The Yogratnakar brought up the use of shoulder joint movements, or Bahu-Parivartana, as a cure for frozen shoulder (12). Descriptions of Avabahuka can also be found in other Ayurvedic texts, such as Bhaisajya Ratnawali, Sahasrayoga, Gadnigraha, Bangsen, Vangasena and Vrihatnighanturatnakar, etc., (13). The study conducted by Wadnerwar NN et al., concluded that Gunja Beeja Lepa has been proved to be effective in comparison with standard anti-inflammatory Ayurvedic drug Shunthi in inflammatory conditions of either mono or bi Arthritis. But the local application should be restricted for limited time only to avoid adverse drug reaction. Similar study can be conducted with red variety of Gunja with Shodhana and white variety of Gunja with and without Shodhana to assess their efficacy without any adverse effects. As Gunja has been proved efficacious for external application in reducing pain and inflammation, the liniments or spray with the ingredients of Gunja may open new dimensions in sports medicine to relive the pain and swelling instantly (14). The study conducted by Akki M et al., concluded that Avabahuka can be co-related to Frozen Shoulder based on the clinical features mentioned in classics. Overall, Svalpa Masha Taila Nasya (Group A) is more effective clinically and statistically than Parinata Keriksheeradi Taila Nasya (Group B) in almost all the parameters. Highly significant results indicated that therapeutic effects like Vedanasthapana, Sthambhara, i.e., improvement in degree of shoulder joint movement is achieved to great extent by Nasya Karma (15). The study conducted by Tankitjanon P et al., compared the Topical Diclofenac (TD) and Court-type Traditional Thai Massage (CTTM) in a randomised controlled experiment to treat frozen shoulder. In terms of enhancing Shoulder Range of Motion (SROM) and reducing the severity of discomfort, the results indicated that CTTM was superior than TD. Over the course of six weeks, both treatments significantly improved SROM and discomfort, although CTTM made more progress than TD in these areas. After therapy, the CTTM group also had considerably superior quality of life scores. Additionally, CTTM has shown no adverse effects, indicating that it is a viable non pharmacological option for treating frozen shoulder (16).
The aim of the present study is to evaluate the comparative efficacy of Gunja Beeja ointment versus Diclofenac Sodium ointment in the management of Avabahuka (frozen shoulder).
Primary objective:
• To assess the efficacy of Gunja Beeja Ointment on objective and subjective parameters of Avabahuka (frozen shoulder).
• To assess the efficacy of Diclofenac Sodium Ointment on subjective and objective parameters of Avabahuka (frozen shoulder).
• To compare the effectiveness of Gunja Beeja Ointment and Diclofenac Sodium Ointment on subjective and objective parameters of Avabahuka (frozen shoulder)
Null hypothesis (H0)- Gunja Beeja Ointment is not as efficacious as Diclofenac Sodium Ointment in management of Avabahuka (frozen shoulder).
Alternate hypothesis (H1)- Gunja Beeja Ointment is as efficacious as Diclofenac Sodium Ointment in management of Avabahuka (frozen shoulder).
Material and Methods
This single-blind, parallel randomised controlled trial will take place over a period of one and a half years (February 2025-January 2026) at the Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H) Wardha,Maharashtra,India with a sample size of 60 subjects, 30 in each group. The ethical approval is obtained from the Institutional Ethical Committee (IEC) (MGACHRC/IEC/Jun-2024/841). The CTRI/2024/07/070559. Registration number for the experiment is attached to it. Prior to the trial commencing, informed consent will be obtained. (Table/Fig 1) shows the study protocol’s Gantt chart.
Sample size calculation: Sample size by Cohen’s effect size by comparing two means for assessing pain using VAS between two groups Group A- Gunja Beeja Ointment Group B- Diclofenac sodium ointment:
Effect size=d= μ2-m1/d2=0.8 (Estimated)
Considering large effect size difference=0.8 (Large effect size)
Z1-α/2 at 5% level of significance=1.96
Z1-β at 80% Power=0.84
Ratio allocation (Group 2/Group 1)=1
Considering 15% drop out total=4
Total 30 samples required per group.
Inclusion criteria:
• Patient willing to participate with written informed consent
• Age group between 31-60 years of either sex
• Painful/Freezing Stage (10 to 36 weeks) and Frozen Stage (4 to 12 months) of Avabahuka
• Patients having clinical sign and symptoms of Avabahuka
Exclusion criteria:
• Known cases of Dislocation and fracture of shoulder joint
• History of trauma to shoulder
• Other disorders like uncontrolled diabetic mellitus, cancer, TB etc.,
• Pregnant and lactating women
Withdrawal criteria: Subject will be withdrawn from the study if any adverse effect or aggravation of symptoms arise. Then the subjects will be offered treatment free of cost till the problems subside.
Preparation of drug: The local market will be the source of the raw medications.
Identification and authentication will be done by Dravayguna Department, MGACH & RC, Salod (H), Wardha, Maharashtra, India. Under the direction of subject matter specialists, Good Manufacturing Practices (GMP)-certified Rasa Shala (Dattatraya) of MGACH & RC will prepare Gunja Beeja Churna. Toxins will be removed from the Gunja seeds while maintaining their effectiveness using a 6-hour boiling process at 100°C in cow’s milk (Shodhana) (17). The Gunja Beeja Taila will be heated until the foam is removed. Wax will become liquefied when heated. After adding Gunja Beeja Taila and stirring until a homogeneous mixture forms, a semisolid ointment formulation with a consistent consistency will be produced. It will be filled in suitable containers (tubes). The patients will be advised to apply it in quantity sufficient on affected area, once a day for seven days. Diclofenac sodium in the form of ointment will be purchased, under the brand name Dicloliv from Livealth BioPharma Pvt., Ltd.
Shoulder home exercise: Pendular exercise, wall climb stretching exercise (finger walk), scapular retraction and posterior capsule stretch will be advised all the participants, once a day for seven days, for twenty minutes in each group (18).
Primary outcomes: There will be reduction in objective Bahupraspandhitahara (range of movement) and Amsashosh (Muscle wasting) and subjective Amsasandhi Shoola (Pain in shoulder joint), Amsasandhi Stabdhata (Stiffness of shoulder joint), and DASH questionnaire parameters.
Schedule of enrollment, interventions: Drugs administration will be once a day for seven days. Following the intervention, assessments will be made on days 0-7 and 14; follow-up will be conducted on day 14.
Implementation: The subjects will be registered by principal investigator, and assessment will be done by the second investigator, there will be two groups, each with 30 patients (Table/Fig 2).
The protocol for the study has been presented in (Table/Fig 3).
Assessment Criteria
Objective criteria
• Bahupraspandhitahara (range of movement of shoulder)- using Goniometer (19).
• Amsashosh (Muscle wasting)- measured in centimetres
Subjective criteria
• Amsasandhi shoola (Pain in shoulder joint)- by Visual Analogue Scale (20).
• Amsasandhi stabdhata (Stiffness of shoulder joint)- by scoring method (21)
• DASH questionnaire (22).
DASH questionnaire (Disability of arm, shoulder, and hand): It is an appropriate tool for the evaluation of upper limb pathology according to WHO guidelines. In 1996 Hudak published their move toward the assessment of disability-the DASH score, a self-administrated questionnaire which includes 30 points related to functional activities and symptoms in Activities of Daily Living (ADL). The patient is asked to point a score of 1 to 5 on all 30 points. Scores rise with increasing disability (Table/Fig 4).
Data coding will be handled by the principal investigator. Prior to the study’s commencement, the patient’s written consent will be obtained. Every patient’s confidentiality will be upheld throughout the investigation. Publication of papers will be used to spread the data. The qualifying criteria for authors and the planned usage of expert writers. Informed written consent will be taken from each participant.
Statistical Analysis
All the result will be calculated using Statistical Package for Social Sciences (SPSS) software version 17. Descriptive statistics will be performed for describing all demographic variables, frequency and percentage will be calculated for qualitative measurement mean standard deviation will be calculated for quantitative measurement. Parametric and non-parametric tests will be used to calculate quantitative and qualitative data respectively. Comparison will be done by using Chi-square test for qualitative data. Paired and unpaired t-test will be used for analysing quantitative data. Outcome variables like Amsasandhi shoola (pain in shoulder joint) will be assessed by visual analogue scale. Amsasandhi stabdhata (Stiffness of shoulder joint) by scoring method and quality of life will be assessed by DASH questionnaire score. Amsashosh (Muscle wasting) will be measured in centimetre and Bahupraspandhitahara (range of movement of shoulder) will be measured in angles by goniometer. The level of significance is taken at 0.05 or 5%. The expected outcome of the study will be reduction in objective Bahupraspandhitahara (range of movement), Amsashosh (Muscle wasting) and subjective Amsasandhi Shoola (Pain in shoulder joint), Amsasandhi Stabdhata (Stiffness of shoulder joint), and DASH questionnaire parameters.
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DOI: 10.7860/JCDR/2025/75749.21169
Date of Submission: Sep 23, 2024
Date of Peer Review: Nov 01, 2024
Date of Acceptance: Feb 27, 2025
Date of Publishing: Jul 01, 2025
AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• 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 26, 2024
• Manual Googling: Feb 22, 2025
• iThenticate Software: Feb 25, 2025 (11%)
ETYMOLOGY: Author Origin
EMENDATIONS: 6
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