DOI: 10.4103/ijra.ijra_21_26 ISSN: 3117-4051

An Open-label, Randomized, Exploratory, Noninferiority Trial of Ruta graveolens 200cH and Individualized Homeopathic Medicines in Tennis Elbow in Adults

Reshma Pilanghu, Chintamani Nayak, Divya Bhardwaj, Arunava Nath, James Michael, Priyanka Sen, Munmun Koley, Subhranil Saha
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Abstract

Background:

Tennis elbow (TE), a common musculoskeletal disorder causing elbow pain and functional limitation, lacks a superior conservative intervention. In homeopathy, both individualized homeopathic medicines (IHMs) and specific remedies like Ruta graveolens (RG) – indicated for tendon, periosteum, and joint affections – are used.

Materials and Methods:

An open-label, two-arm parallel exploratory trial randomized (1:1) 60 participants (18–65 years) with clinically diagnosed TE to either RG 200cH or IHMs. Primary outcome: Patient-rated TE Evaluation (PRTEE); secondary: Numerical Rating Scale (NRS) assessed at baseline, 2, and 4 months. Analyses included linear mixed-effects models, noninferiority testing, and a hierarchical Bayesian linear model with prior sensitivity analysis. Subgroup and moderator analyses were conducted to assess treatment stability.

Results:

Both groups demonstrated significant reductions in PRTEE pain, function, total scores, and NRS pain from baseline to month 4 (all P < 0.001). Between-group differences were not statistically significant at any time point. Noninferiority of RG 200cH was demonstrated at 2 months for selected PRTEE domains but not consistently at 4 months. Bayesian analysis showed overlapping credible intervals centered near zero, supporting clinical equivalence between interventions. Sensitivity, subgroup, and moderator analyses confirmed methodological robustness and consistency of effects across demographic and clinical variables. No adverse events were reported.

Conclusions:

Both RG 200cH and IHMs showed comparable and clinically meaningful improvement in TE, with no significant difference between groups, supporting their clinical equivalence. Larger, rigorously controlled trials are warranted to confirm effectiveness and long-term outcomes.

Trial Registration:

CTRI/2018/10/016175.

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