Evaluation of the therapeutic effect of Vishwadi Kwatha in the management of post-operative pain: An exploratory randomized controlled clinical trial

Abstract BACKGROUND: Post-operative pain remains a significant concern in surgical recovery, often managed with nonsteroidal anti-inflammatory drugs with a risk of side effects and complications, which raises the need for safer alternatives. Vishwadi Kwatha , an Ayurvedic formulation, has been traditionally used to manage pain and inflammation. OBJECTIVES: To evaluate the effect of Vishwadi Kwatha versus diclofenac sodium in the management of post-operative pain. MATERIALS AND METHODS: A parallel-arm, randomized controlled pilot study was conducted at KLE Shri BMK Ayurveda Mahavidyalaya and Hospital on 30 post-operative patients who had undergone surgery. Participants were randomized in a 1:1 ratio into two groups: The trial group received Vishwadi Kwatha (48 mL, thrice daily), and the control group received diclofenac sodium (50 mg, twice daily) for three consecutive days. The primary outcome was the reduction in post-operative pain, assessed using the visual analog scale (VAS) and verbal descriptor scale (VDS). Secondary outcomes, including blood pressure and pulse rate, were monitored every 8 h for 3 days post-operatively. Statistical analysis was performed using the Wilcoxon signed-rank test for within-group comparisons and the Mann–Whitney U test for between-group comparisons. RESULTS: All 30 participants (aged 30–50 years) completed the study with good adherence. Mild adverse events (AEs), such as nausea, dizziness, and gastrointestinal discomfort, were reported in a few participants in Group A and in 4% of Group B, which was self-limiting. Both groups showed significant pain reduction over 72 h. Group A had significantly lower VAS and VDS scores at 48 and 72 h compared to Group B ( P < 0.01). No severe AEs occurred, and the intervention was well-tolerated. CONCLUSION: This pilot study indicates that Vishwadi Kwatha is a feasible and well-tolerated intervention for post-operative pain management. Preliminary findings suggest potential benefits in pain reduction compared to diclofenac sodium. However, larger, adequately powered studies are needed to confirm these results and further establish their clinical efficacy and safety. TRIAL REGISTRATION: CTRI/2022/12/04486, dated September 13, 2022.