FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/04/018852 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 29/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety & Efficacy assessment of new Ayurvedic antimicrobial vaginal tablet for the treatment of leucorrhea through clinical trials.  
Scientific Title of Study   Estimation of the therapeutic efficacy of a novel Ayurvedic Vaginal tablet in treating excessive abnormal vaginal discharge during Phase II clinical trials 
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  Institute of Post Graduate Ayurvedic Education and Research 
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

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  Institute of Post Graduate Ayurvedic Education and Research 
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


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  Institute of Post Graduate Ayurvedic Education and Research 
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


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 Kolkata (from ICMR sanctioned project fund vide No. 5/10/FR/7/2018 - RCH dated 11.6.2018) 
 
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, IPGAE&R, 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= 1  
Name of Committee  Approval Status 
Institutional ethical committee for Clinical Trial on Human subjects at Institute of Post Graduate Ayurvedic Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N761||Subacute and chronic vaginitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic mucoadhesive vaginal tablet combination of equal amounts of dried parts of the stem bark of Udumber Ficus glomerata Roxb.andLodhra Symplocos racemosa Roxb   One Ayurvedic novel formulated and standardized vaginal tablet per day up to 15 days at night & proper cleaning of the external genital parts of female patients  
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   Computer generated randomization 
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. 
The final outcome of each participant will be evaluated after 15 days of treatment,i.e at the end of her study period.  
 
Secondary Outcome  
Outcome  TimePoints 
The primary outcome will be justified on the
basis of vaginal fluid study, microbiological
study, Routine haematological investigation,hormone FSH, LH, TSH analysis and also urine in this study 
Day 1 Day 15 Pre treatment and post treatment analysis  
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   15/05/2019 
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   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.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.

 
Close