Vol. 9, Issue - 3, Part A (2025)

Arzeena jabeen, Humaira Bano, Nikhat Shaikh, Jamal Akhtar and Nighat Anjum

DOI: https://doi.org/10.33545/2616454X.2025.v9.i3a.373

Abstract:
Objective: To validate the efficacy of Unani pharmacopoeial formulation Habb-e-Mudir in patients with Iḥtibās al-Tamth (amenorrhea). Methods: An open-label, multi-centric clinical trial was conducted at RRIUM Mumbai and NRIUMSD Hyderabad, enrolling 132 patients with secondary amenorrhea aged 18-40 years. Participants received Habb-e-Mudir tablets (containing Aloe barbadensis 2gm, Ferrous sulphate 1gm, and Crocus sativus 1gm) three times daily for 5 consecutive days from expected menses date, continued for 3 months. Primary endpoints included restoration of normal menstruation and withdrawal bleeding assessment parameters. Results: Complete efficacy data from Mumbai center (n=49) demonstrated progressive menstrual restoration: 89.8% after first cycle, 100% after second cycle, and sustained response in 95.9% at final assessment. Duration of menstrual flow significantly improved from baseline 1.8±0.6 days to 3.8±1.2 days (111% increase). Severity scoring showed 68.4±24.7% mean improvement. Treatment response classification revealed complete relief in 57.1%, partial relief in 38.8%, and treatment failure in only 4.1%. Safety assessment across all 132 patients showed zero adverse events with normal post-treatment laboratory parameters. Conclusion: Habb-e-Mudir demonstrated excellent therapeutic efficacy (95.9% success rate) and safety profile in treating secondary amenorrhea, supporting its integration into evidence-based gynecological practice within the Unani system of medicine.