Chopra 2004.

Methods	Randomised, double‐blind, placebo control, 2 parallel groups. Duration 32 weeks
Participants	Randomised n=90, intervention n=45, control n=45. Midpoint (16 weeks) n=78. Completed n=62, intervention n=31, control n=31. Age 35+ years. OA knee (ACR criteria). Stable NSAIDs for 1 month at baseline. Not pregnant
Interventions	RA‐11: Ayurvedic medication, 2 capsules Placebo control: ingredients not reported Rescue medication not permitted Concurrent medication permitted: stable medication for concomitant diseases
Outcomes	WOMAC 0‐4 (Asian ‐ Indian modification), VAS 0‐100, 50 feet walk time (seconds), physician global assessment 0‐4, patient global assessment 0‐4, early morning stiffness (minutes), knee swelling 0‐3
Notes	Confirmatory study design, power 80%, alpha 0.05 (2 tailed). Did not report ethical oversight or compliance with guidelines. Results favour intervention.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Described as randomised: "...assigned to the active or placebo groups as per a predetermined computer generated randomisation schedule..."
Allocation concealment (selection bias)	Low risk	Adequate allocation concealment can be inferred: "A sealed copy of the randomization code was kept with the sponsor and the chief investigator but was not revealed to the subjects or the clinical staff until completion of the study."
Blinding (performance bias and detection bias) All outcomes	Low risk	Active intervention and placebo not distinguished by look, taste, smell, packaging, or medication regimen
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Reported withdrawals. Included intention‐to‐treat analysis. Last observation carried forward to replace missing data (low risk) Three participants were withdrawn by the investigators due to "efficacy failure", which may confound results (unclear risk)
Selective reporting (reporting bias)	Low risk	Pre‐determined levels of improvement (MCID) (low risk) Reported adverse events. Two participants in intervention group died, but these deaths were attributed to concomitant cardiovascular disease
Other bias	Low risk	Diagnosis consistent with ACR criteria (low risk)