Clinical evaluation of Pushyanug Churna in the management of bacterial vaginosis: A prospective single-arm multicenter pilot study

BACKGROUND: Bacterial vaginosis (BV) is among the most prevalent disorders of the female genital tract and is a common cause of leucorrhea. In Ayurvedic literature, the symptomatic presentation of BV can be correlated with Swetapradara . In addition to contemporary medical management approaches, Ayurveda offers traditional formulations that can contribute to comprehensive management strategies for BV. Pushyanug Churna (PC), a classical Ayurvedic herbo-mineral formulation traditionally indicated for Raktapradara and Swetapradara , was evaluated for its role in the management of BV in this pilot study. The objective of this study was to clinically evaluate PC in the management of BV. MATERIALS AND METHODS: This prospective, single-arm, multicenter pilot study enrolled 80 women aged 18–40 years presenting with complaints of white vaginal discharge and diagnosed with BV. Participants received PC (3 g) twice daily with 50 mL of Tandulodaka (rice-washed water) after meals for 60 days. Follow-up assessments were conducted every 15 days during the treatment period (day 15, 30, 45, and 60) and once post-treatment on day 90. Primary outcome measures included the proportion of participants achieving clinical cure, assessed by resolution of symptoms and Amsel’s criteria. Secondary outcomes were change in symptom severity measured by the visual analogue scale (VAS), bacteriological cure defined as Gram stain Nugent score <4, and improvement in quality of life assessed by the SF-36 questionnaire. RESULTS: Of the 80 participants enrolled, 13 were lost to follow-up, and data from 67 participants were analyzed. At the end of treatment, compared to baseline, symptomatic relief was observed in 43.3% for excessive vaginal discharge, 89.6% for fishy odor, 68.7% for vaginal itching, 92.5% for vaginal burning, 95.5% for burning micturition, 86.6% for dyspareunia, and 38.8% for low backache. Symptom severity, assessed using the VAS, showed statistically significant improvement across all symptoms ( P < 0.001). Significant remission was also observed in Amsel’s criteria and Nugent’s score ( P < 0.001). Quality of life, measured using the SF-36 questionnaire, demonstrated significant improvement in all eight domains ( P < 0.001). No adverse drug reactions (ADRs) or events were reported during the study. CONCLUSION: The findings of this pilot study suggest that PC has potential benefits in the management of BV, as indicated by clinical, bacteriological, and quality of life improvements. The intervention was well-tolerated, with no ADRs reported. While these results are promising, further evaluation through randomized controlled trials is warranted to confirm efficacy and establish comparative effectiveness. TRIAL REGISTRATION: CTRI/2018/07/014717, dated 03/07/2018.