Multi-dimensional scientific evaluation including in-vitro & in-vivo assessment and standardization of Ayurvedic vaginal tablets (Code-NA) for the treatment of Leucorrhea (excessive and abnormal vaginal discharge)

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 herbal vaginal tablet having for its treatment.

The aim of present study is to develop once daily muco-adhesive vaginal delivery system for the herbal combination drug of stem bark of  Neem (Azadirechta indica) and Asoka (saraca asoka)  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 concentrations at the site of infection.

Formulated Ayurvedic herbal vaginal tablets will be evaluated 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 new 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.