EFFICACY OF BIBHITAK (TERMINELIA BELLIIRICA ROXB) PHALA MADHYA LEPA (FRUIT PULP APPLICATION) ON PAINFUL KNEE JOINT IN SANDHIGATAVATA - A PILOT STUDY

Abstract

Background: Sandhigata Vata is an age-associated disorder characterized predominantly by joint pain, swelling, painful flexion–extension, stiffness and crepitus, and it is commonly correlated with knee osteoarthritis. Conventional care may be inadequate or unsafe for some patients, creating a need for simple, affordable and non-invasive supportive interventions. Classical Ayurvedic texts describe Bibhitak phala madhya lepa, an external paste prepared from the fruit pulp of Terminalia bellirica, for pain, swelling and burning sensation. Objective: To evaluate the efficacy of Bibhitak phala madhya lepa in reducing knee-joint vedana (pain), shotha (swelling) and daha (burning sensation) in patients with Sandhigata Vata. Methods: This prospective, open-label, single-arm pilot clinical trial enrolled 10 pre-diagnosed patients aged 30–70 years from an institutional hospital. Eight participants had bilateral involvement; therefore, 18 knees were treated and analyzed. Freshly prepared paste was applied once daily in the evening for at least one hour for seven days. Outcomes were assessed at baseline, day 7 and day 14. Pain was measured using a visual analogue scale, swelling by circumferential tape measurement, and burning sensation by a four-point ordinal scale. Paired t tests were reported for pain and swelling and a Wilcoxon signed-rank test for burning sensation. Results: Mean pain decreased from 8.33 to 6.39 (t=5.07; p<0.05), and mean knee circumference decreased from 38.39 cm to 37.28 cm (t=5.66; p<0.05). Both changes were reported as statistically significant. Mean burning-sensation score decreased from 0.611 to 0.056, but the reported Wilcoxon result was statistically non-significant (W=15, Z=−2.02; p>0.05). No safety concern was described in the source report. The sample was predominantly female (80%), older (50% aged 61–70 years), rural (60%), and composed largely of homemakers (60%); 60% reported hard bowel habits. Conclusion: Bibhitak phala madhya lepa produced promising short-term reductions in pain and swelling, but evidence for burning sensation was inconclusive. Because the study was small, uncontrolled and based on knee-level analysis nested within participants, the findings should be considered hypothesis-generating and verified in a larger randomized controlled trial.