Estimation of the therapeutic efficacy of a novel Ayurvedic Vaginal tablet in treating excessive abnormal vaginal discharge during Phase II clinical trials

The per vaginal excessive abnormal discharge of vagina, itching around the external part of genital organs are common symptoms of large population of female patients in India due to unhygienic condition, poor diet, general weakness etc. Vaginal complaints are very common in the general population and are one of the most frequent reasons for patient visits to obstetrician-gynecologists. Vaginitis is defined as the spectrum of conditions that cause vulvo-vaginal symptoms. Chronic vaginal problems have a significant impact in the overall health and well-being of affected women. It is a disease which is mentioned by the Charak in the Charak Samhita under the upadravas of Yoni-Vyapat Roga (Ch. Chikitsa 30/39 & 131) in the pradar roga that means excessive abnormal discharge coming out from the vagina. There are two type of this disease based on the basis of colour of the discharge. If excessive abnormal vaginal discharge is yellowish-white, thick & purulent it is called Sweta Pradar (Leuchorrhea).

Although leucorrhoea is one of the most common female ailments, there is no safe, cost-effective antimicrobial Ayurvedic herbal vaginal tablet having for its treatment.

The aim of present study is to develop once daily muco-adhesive extended release vaginal delivery system for the herbal combination drug having stem bark of Ficus glomerata Roxb. and Symplocos racemosa Roxb plants which is designed to improve the adhesion to the vagina in order to prolong the residence time and consequently to obtain a long therapeutic concentration at the site of infection.

Formulated Ayurvedic herbal vaginal tablets have been evaluated and standardized for bio-adhesive properties, in vitro and in situ release studies, in vitro swelling studies and stability studies along with phytochemical standardization for marker compound and in vitro anti-microbial property. After getting the significant result of the standardized Ayurvedic vaginal tablet, the clinical trial on female human subject will be done for the treatment of Sweta prader (Excessive vaginal discharge) called Lecucorrhea and other associated symptoms in the hospital of this Institute.

The research effort will establish the pre-clinical efficacy and clinical study of a proposed herbal formulation after rigorous scientific evaluation through phytochemical studies, antimicrobial, antibacterial, antifungal and concerned animal experiments (Acute toxicity, Dermal toxicity and mucosal toxicity).

This novel research vaginal tablet will be a cost effective, safe, easy to use, easily available antimicrobial herbal standardized drug for the treatment of leucorrhoea in female human subjects.

Publications:

1.Mradu Gupta et al, Pharmacognostic and Chemical Standardization of Vaginal Herbal Formulation Extracts Using Spectroscopy (UV-VIS & FTIR) and Chromatography (HPTLC, HPLC & GC-MS) Methods, International journal of Pharmacy and Pharmaceutical Research, Human journals, 2017; 9(2): 21-51.

 2.Mradu Gupta et al, Formulation, development and standardization of an Ayurvedic muco-adhesive extended release vaginal tablet, International Journal of Pharmacognosy, 2018;  5(1):15-25.

 3.Mradu Gupta et al, Design and Standardization of Novel Muco-Adhesive Vaginal Herbal Tablet for Treatment of Leucorrhea Using In-Vitro & In-Situ Methods, International Journal of Pharmaceutical Sciences Review and Research, 2017; 45(2): 187-197.

 4.Mradu Gupta et al, Assessment of oral toxicity and vaginal irritation test of novel antimicrobial mucoadhesive herbal vaginal tablet for the treatment of vaginitis, International Journal of Green Pharmacy,2018:12(1): 15-24.