Efficacy of Gunja Beeja Ointment versus Diclofenac Sodium Ointment in the Management of Avabahuka (Frozen Shoulder): A Research Protocol for a Randomised Controlled Trial

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.