A Randomized Controlled Trial Comparing the Analgesic Efficacy of Ehretia laevis Roxb. (Khandu Chakka/Ajan Vruksha) Leaf Powder and Diclofenac Sodium

Abstract

Pain is a major clinical concern affecting quality of life globally. While Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like Diclofenac Sodium are effective in pain relief, their long-term use poses safety concerns. This study aimed to evaluate the efficacy and safety of Ehretia Roxb. leaf powder a traditionally used Ayurvedic herb compared to Diclofenac Sodium in musculoskeletal pain management. A randomized, single-blind, standard-controlled clinical trial was conducted on 142 patients aged 20–80 years with musculoskeletal pain. Participants were randomly assigned to receive Ehretia laevis Roxb. capsules (500 mg TID) or Diclofenac Sodium tablets (50 mg BID) for 15 days. Pain intensity was measured using the Universal Pain Scale i.e Visual Analogue Scale. Statistical analyses included t-tests, repeated measures ANOVA, and effect size calculations. Both groups showed significant within-group pain reduction over 15 days (p < 0.001). However, Diclofenac Sodium demonstrated superior efficacy with a 91.4% average pain reduction, compared to 56.5% with Ehretia laevis Roxb. The ≥50% pain reduction response rate was 97.2% in the Diclofenac group versus 60.6% in the Ehretia laevis Roxb.  group. Complete response (VAS ≤ 1) occurred in 78.9% and 16.9% of participants respectively. Time to 50% relief was earlier in the Diclofenac group (Day 6–9) than in the Ehretia laevis Roxb.  group (Day 9–12). Diclofenac Sodium was significantly more effective in reducing pain intensity quickly and completely. Nonetheless, Ehretia laevis Roxb. showed a moderate but consistent effect, highlighting its potential as a safer herbal alternative requiring further exploration through long-term, large-scale trials.