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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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