CTRI Number |
CTRI/2019/03/017986 [Registered on: 08/03/2019] Trial Registered Prospectively |
Last Modified On: |
06/03/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Evaluation of anti-microbial effect of Ayurvedic vaginal tablet in treatment of leucorrhea using animal experiments and human trials |
Scientific Title of Study
|
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) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mradu Gupta |
Designation |
Professor and HOD |
Affiliation |
Department of Health & Family Welfare, Govt. of West Bengal |
Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research
294/3/1 A. P. C. Road
Kolkata WEST BENGAL 700009 India |
Phone |
9433665125 |
Fax |
|
Email |
mradu_gupta@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mradu Gupta |
Designation |
Professor and HOD |
Affiliation |
Department of Health & Family Welfare, Govt. of West Bengal |
Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research
294/3/1 A. P. C. Road
Kolkata WEST BENGAL 700009 India |
Phone |
9433665125 |
Fax |
|
Email |
mradu_gupta@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mradu Gupta |
Designation |
Professor and HOD |
Affiliation |
Department of Health & Family Welfare, Govt. of West Bengal |
Address |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research
294/3/1 A. P. C. Road, Kolkata -700009
Kolkata WEST BENGAL 700009 India |
Phone |
9433665125 |
Fax |
|
Email |
mradu_gupta@hotmail.com |
|
Source of Monetary or Material Support
|
Institute of Post Graduate Ayurvedic Education and Research
294/3/1 A. P. C. Road Kolkata -700009 |
|
Primary Sponsor
|
Name |
Institute of Post Graduate Ayurvedic Education and Research |
Address |
294/3/1 A. P. C. Road Kolkata -700009 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Mradu Gupta |
Institute of Post Graduate Ayurvedic Education and Research |
Room No. 2, Department of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research
294/3/1 A. P. C. Road Kolkata -700009 Kolkata WEST BENGAL |
9433665125
mradu_gupta@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional ethical committee for Clinical Trial on Human subjects at Institute of Post Graduate Ayurvedic Education and Research |
Approved |
Institutional Ethical Committee for Clinical Trials at IPGAER Kolkata |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Continuous per vaginal excessive abnormalwhite discharge exceptovulationperiod in Female patients, Itching around external genital parts, Pain in back, Constipation,Loss ofappetite,Painful intercourse, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ayurvedic mucoadhesive vaginal tablet combination of stem bark of Neem (Azadirechta indica )and Asoka (saraca asoka)
|
One vaginal tablet per day up to 15 days
|
Comparator Agent |
Standard candid vaginal tablet |
Per vaginal standard tablet up to 15 days |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Female |
Details |
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
|
|
ExclusionCriteria |
Details |
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 |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in excessive abnormal vaginal discharge and associated symptoms, improvement in genital health condition and well beings. |
Day 1 Day 15 |
|
Secondary Outcome
|
Outcome |
TimePoints |
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 |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
01/05/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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. |