Background:Habb-e-Mudir is a classical Unani pharmacopoeial formulation containing Aloe barbadensis, ferrous sulphate, and Crocus sativus, traditionally used for treating amenorrhea (Iḥtibās al-Tamth). Despite widespread clinical application, comprehensive safety evaluation studies remain limited.
Objective:To systematically evaluate the safety parameters of Habb-e-Mudir in patients diagnosed with secondary amenorrhea using standardized clinical assessment protocols.
Methods: This open-label, multi-centric clinical study was conducted at Regional Research Institute of Unani Medicine, Mumbai and Central Research Institute of Unani Medicine, Hyderabad. A total of 132 patients aged 18-40 years with secondary amenorrhea received 1 tablet thrice daily for 5 consecutive days per menstrual cycle for 3 months. Safety assessment included clinical monitoring, vital signs, and comprehensive laboratory investigations including hematological parameters, liver function tests, kidney function tests, and urinalysis at baseline and post-treatment.
Results: No serious adverse events were reported throughout the 3-month treatment period. All patients demonstrated excellent medication tolerance with zero treatment discontinuations due to adverse effects. Laboratory parameters including hemoglobin levels, total leucocyte count, liver enzymes (SGOT, SGPT, serum bilirubin, alkaline phosphatase), and kidney function markers (serum creatinine, blood urea) remained within normal physiological ranges across both centers, indicating no hepatotoxicity, nephrotoxicity, or hematological adverse effects.
Conclusion:Habb-e-Mudir demonstrates an excellent safety profile for secondary amenorrhea treatment, supporting its clinical applicability in contemporary healthcare settings. The consistent multi-centric findings establish this Unani formulation as a safe therapeutic option.