Preliminary efficacy of shallakyadi capsules (Ayurvedic intervention) on post-chikungunya chronic inflammatory rheumatism: Single-arm, open-label clinical trial

Over 40 % of chikungunya (CHIK) patients develop arthritic manifestations resembling amavata disease as described in Ayurveda. Therefore, a clinical trial was planned to establish the efficacy and safety of the Ayurvedic medicine shallakyadi capsules on post-chikungunya chronic inflammatory rheumatism (pCHIK-CIR). A single-centre, open-label, single-arm, clinical trial was conducted on the participants with pCHIK-CIR. A total of 90 participants were treated with shallakyadi capsule, in a dose of two capsules twice daily (each of 500 mg), orally before lunch and dinner for two months. The primary outcomes were disease activity score (DAS-28) and clinical disease activity index (CDAI), while secondary outcomes were health assessment questionnaire (HAQ) and changes in clinical symptoms. Mean changes were calculated using paired t-tests (for continuous data) and the Wilcoxon signed-rank test (ordinal data). A significant improvement was observed in the changes between before and after treatment for the primary and secondary outcomes, viz. DAS-28 (mean difference (MD) ± standard deviation (SD): 1.27 ± 0.74, p < 0.001), CDAI (MD ± SD: 8.85 ± 4.34, p < 0.001), HAQ (MD ± SD: 13.73 ± 5.71, p < 0.001). In contrast, changes in C-reactive protein (CRP) (MD ± SD: 1.17 ± 9.3, p = 0.25) and erythrocyte sedimentation rate (ESR) (MD ± SD: 2.1 ± 13.1, p = 0.14) were statistically insignificant. No adverse drug reactions were observed. Shallakyadi capsule improves disease activity, quality of life and symptomatic relief with no adverse effects in pCHIK-CIR cases during a two-month treatment regimen. The study demonstrates the feasibility and potential of Ayurvedic treatment for post-chikungunya arthritis, underscoring the need for larger, well-designed multicentre trials.