Evaluation of anti-microbial effect of Ayurvedic vaginal tablet in treatment of leucorrhea using animal experiments and human trials

Phase 1/2

Not yet recruiting

Conditions: Continuous per vaginal excessive abnormalwhite discharge exceptovulationperiod in Female patients, Itching around external genital parts, Pain in back, Constipation,Loss ofappetite,Painful intercourse

Registration Number: CTRI/2019/03/017986

Lead Sponsor: Institute of Post Graduate Ayurvedic Education and Research

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

1 Continuous per vaginal excessive abnormal white discharge except ovulation period 2 Itching around the external genital parts 3 Pain in the back region 4 Painful intercourse.

Exclusion Criteria

1 Pregnancy 2 History of significant per vaginal bleeding 3 prolapsed of uterus 4 Malignancy in the internal genital parts 5 Allergy to known constituents 6 Severely ill patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in excessive abnormal vaginal discharge and associated symptoms, improvement in genital health condition and well beings.	Day 1 Day 15

Secondary Outcome Measures

Name	Time	Method
The primary outcome will be justified on the basis of vaginal fluid study, microbiological study, Routine haematological investigation and also urine in this study	Day 1 Day 15

Trial Locations

Locations (1): Institute of Post Graduate Ayurvedic Education and Research
🇮🇳
Kolkata, WEST BENGAL, India
Institute of Post Graduate Ayurvedic Education and Research
🇮🇳Kolkata, WEST BENGAL, India
Dr Mradu Gupta
Principal investigator
9433665125
mradu_gupta@hotmail.com