Clinical Efficacy and Safety of the Unani Pharmacopoeial Formulation Sailani in the Management of Sayalān al-Rahim (Excessive Abnormal Vaginal Discharge): An Open-Label Clinical Trial

Background: Sayalān al-Rahim, characterized by excessive abnormal vaginal discharge (EVD), is prevalent in Indian women of reproductive age (prevalence: 26.3% in rural India) and is associated with significant morbidity. The Unani formulation Sailani possesses documented astringent, antimicrobial, and uterotonic properties; however, clinical evidence validating its therapeutic use remains limited.
Objective: To evaluate the clinical efficacy and safety of Sailani in managing Sayalān al-Rahim over a four-week treatment period.
Methods: An open-label clinical study was conducted at RRIUM Mumbai, enrolling 100 women aged 18–45 years presenting with (EVD),. Participants received Sailani tablets (2 tablets twice daily post-prandially with lukewarm water) for four weeks. Clinical symptoms, laboratory parameters (CBC, LFT, KFT, urine analysis), and quality of life (WHO-BREF) were assessed at baseline, Week 2, and Week 4.
Results: Statistically significant reductions were observed in discharge quantity, vulval itching, low backache, and generalized weakness (p < 0.01). No clinically significant adverse effects or haematological/biochemical abnormalities were recorded. WHO-BREF domain scores demonstrated significant improvements across physical, psychological, and social dimensions. Conclusion: Sailani demonstrated clinically meaningful efficacy and an acceptable safety profile in the management of Sayalān al-Rahim, supporting its evidence-based integration into gynaecological practice under the Unani system of medicine.