A RANDOMISED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARBUDAHARA ARKA IN UTERINE LEIOMYOMAS

Background: Uterine leiomyoma is a common benign smooth-muscle tumour of the uterus and may present with menstrual abnormalities, pelvic pain, pressure symptoms and reproductive problems. In Ayurveda, uterine fibroid may be clinically correlated with Granthi/Arbuda on the basis of its localized, nodular and relatively firm character and with involvement of Kapha-Vata and tissues including Rakta, Mamsa and Meda. The present study evaluated Arbudahara Arka, a distillate formulation described for Arbuda, and compared it with Kasisadi Yoga. Aim: To clinically evaluate the efficacy of Arbudahara Arka in uterine leiomyoma and to compare its effects with Kasisadi Yoga on disease-specific subjective and objective parameters. Methods: A randomized, open-labelled, controlled clinical study was conducted on 30 participants with ultrasonographically diagnosed uterine fibroids. Participants were allocated by lottery method into Group A (n=15), receiving Arbudahara Arka 6 ml twice daily before food, and Group B (n=15), receiving Kasisadi Yoga twice daily before food. Treatment was continued for 90 days with assessments at baseline (D0), after 30 days, 60 days and 90 days. Subjective outcomes included pain working ability, pain location, days of pain, pain intensity and menstrual bleeding. Objective outcomes included number and size of fibroids assessed by ultrasonography. Wilcoxon signed-rank and Mann–Whitney U tests were used for non-parametric analysis; clinical effect size was calculated using r = Z/√N. Results: Both groups showed improvement in pain-related symptoms and reduction in menstrual bleeding. Group A showed greater percentage improvement in days of pain (40.0% vs 30.0%) and pain intensity (50.0% vs 20.0%), whereas Group B showed greater improvement in working ability (45.5% vs 31.8%) and pain location (42.1% vs 38.9%). Improvement in menstrual bleeding was comparable (26.3% in both groups). The number of fibroids did not show meaningful reduction in either group. Fibroid size showed statistically significant within-group reduction, with large within-group effect sizes: 0.79 for Group A and 0.85 for Group B. No significant adverse drug reaction or rescue medication was reported. Conclusion: Both Arbudahara Arka and Kasisadi Yoga produced clinically beneficial changes in uterine leiomyoma. Arbudahara Arka showed comparatively greater improvement in several symptom domains, particularly pain duration and intensity, while Kasisadi Yoga showed greater improvement in working ability and pain location. Both interventions demonstrated significant reduction in fibroid size, and between-group analyses generally indicated comparable efficacy.