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CTRI Number  CTRI/2020/07/026626 [Registered on: 16/07/2020] Trial Registered Prospectively
Last Modified On: 13/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   CLINICAL EFFECT OF PUGAKHANDA AND AYUSH PVK GEL ON WHITE DISCHARGE 
Scientific Title of Study   CLINICAL EVALUATION OF AYURVEDIC FORMULATIONS PUGAKHANDA AND AYUSH PVK GEL IN THE MANAGEMENT OF SWETAPRADARA (PATHOLOGICAL LEUCORRHOEA)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VANMALA BAPURAO WAKODE 
Designation  Research Officer (Ayurveda) 
Affiliation  Regional Ayurveda Research Institute For Mother and Child Health Nagpur 
Address  Regional Ayurveda Research InstituteFor Mother and Child Health Nagpur Near Gharkul Parisar NIT complex Nandanvan Nagpur Maharashtra

Nagpur
MAHARASHTRA
440009
India 
Phone  9404669789  
Fax    
Email  dr.vanmala@gov.in  
 
Details of Contact Person
Scientific Query
 
Name  DR VANMALA BAPURAO WAKODE 
Designation  Research Officer (Ayurveda) 
Affiliation  Regional Ayurveda Research Institute For Mother and Child Health Nagpur 
Address  Regional Ayurveda Research InstituteFor Mother and Child Health Nagpur Near Gharkul Parisar NIT complex Nandanvan Nagpur Maharashtra

Nagpur
MAHARASHTRA
440009
India 
Phone  9404669789  
Fax    
Email  dr.vanmala@gov.in  
 
Details of Contact Person
Public Query
 
Name  DR PRASHANT SHINDE 
Designation  Research Officer (Ayurveda) 
Affiliation  Regional Ayurveda Research Institute For Mother and Child Health Nagpur 
Address  Regional Ayurveda Research InstituteFor Mother and Child Health Nagpur Near Gharkul Parisar NIT complex Nandanvan Nagpur Maharashtra

Nagpur
MAHARASHTRA
440009
India 
Phone  9623011214  
Fax    
Email  drshindeprashant07@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES NEW DELHI 
 
Primary Sponsor  
Name  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65 Institutional Area Opposite D-Block Janakpuri New Delhi 110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MEGHNA P P  Regional Ayurveda Research Institute for Lifestyle Related Disorders Thiruvananthapuram  OPD 1 Shastri Nagar poojapura Thiruvananthapuram kerala 695012
Thiruvananthapuram
KERALA 
9495129282

drmeghnapp@gmail.com 
DR VANMALA WAKODE  Regional Ayurveda Research Institute for Mother and Child health care (RARIMCH) Nagpur  Near Gharkul Parisar NIT complex Nandanvan Nagpur 440009 Maharashtra
Nagpur
MAHARASHTRA 
9404669789

dr.vanmala@gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Regional Ayurveda Research Institute for Lifestyle Related Disorders Poojappura Thiruvananthapuram Kerala  Approved 
Regional Ayurveda Research Institute for Mother and Child health care Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  PUGAKHANDA AND AYUSH PVK Gel   Pugakhanda 10 gm twice a day after food with milk for two months AYUSH PVK Gel 3gm once daily applied intra vaginal for 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Married woman of age between 18 to 40 years.
2.Presence of discharge per vaginum with or without itching/burning sensation /dyspareunia /foul smell for at least one month.
3.Patient agrees to refrain from use of douches oral or intra-vaginal antibiotics or antifungal agents or lubricants during the entire study period.
4.Patient willing and agrees to participate for three months and signs informed consent. 
 
ExclusionCriteria 
Details  1)Patient with Pelvic Inflammatory Disease (PID).
2)Patient with Abnormal Papanicolaou smear with
Intra-epithelial or invasive cancer.
3)Patient with unexplained vaginal bleeding.
4)Abnormal findings on pelvic Sonography.
5)Patient with positive pregnancy test.
6)Patient with Fibromyoma, polyp ovarian tumour or cyst prolapse.
7)Systemic disease like heart disease tuberculosis and uncontrolled Diabetes Mellitus Hypertension and Severe anemia i.e Hemoglobin less than 7 gms
8)Use of antibiotics or local vaginal formulation within the previous month
9)Endocervical smear positive for gonococci, or positive VDRL HIV & HbsAg test
10)Patients who are currently participating in any other clinical trial or participated in past four weeks.



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the symptom-vaginal white discharge Foul smell vaginal itching vaginal burning sensation Burning Micturition Pain during intercourse Lower abdominal pain and any other associated symptom   Baseline 15th 30th 45th 60th and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in quality of life of the women in Swetapradara (Pathological leucorrhoea)   Baseline 60th day and 90th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/09/2020 
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   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The term leucorrhoea means, strictly speaking, an excessive normal vaginal discharge, however it has become a generic term covering any purulent vaginal discharge.  Leucorrhoea is still a global problem in spite of many elaborate studies for past decades. It is a common problem which affects many women during their reproductive years. The discharge may range from excess of normal to one which is a part of wide spectrum of ailments. The most common cause of leucorrhoea is physiological, followed by vaginal infections due to bacteria, virus, fungi and parasites. Other causes include foreign bodies, cervicitis and atrophic vaginitis.

Normal vaginal flora consists of both aerobic and anaerobic bacteria, with Lactobacillus species being the predominant microorganisms and accounting for greater than 95% of all bacteria present. Lactobacilli are believed to provide defense against infection, in part by maintaining an acidic pH in the vagina and ensuring hydrogen peroxide is present in the genital environment.

Rationale of the study:

            The word “Swetapradara” has not appeared in Brihatrayee i.e. Charaka Samhita, Sushruta Samhita, and Astanga Hridaya.) For white vaginal discharge Swetastrava or Yonistrava words have been used. Commentator Chakrapani, Sharangadhara Samhita, Bhava Prakash, Yoga Ratnakara have used the word Swetapradara for white vaginal discharge. Swetapradara or white discharge is a symptom of all gynecological disorders (Yonivyapads) developing due to vitiation of Kapha and Vatakapha (Atyananda, Karnini, Acharana, Aticharana, Sleshmala, Upapluta and Prasramsini Yoniivyapada). Commentator Chakrapani has explained the word Pandura-Asrigdara (Pale vaginal discharge) as Swetapradara (leucorrhoea) in his commentary. Acharya Sushruta has described it as a physiological discharge of women secreted during sexual act.

Recently, it has been demonstrated that many human pathogenic bacteria have developed resistance against several synthetic drugs.  Available reports on  lesser  efficacy  and  more  side  effects  of  synthetic  drugs  necessitate  alternative medicine. There are number of drugs mentioned in Ayurveda. Classical Ayurvedic compound Pugakhanda described in Bhaishajyaratnavali is used for the successful treatment of Leucorrhoea since ancient times. Panchavalkala kwatha has been conventionally used for reducing infection and inflammation for centuries.

On the basis of textual and clinical experience compound drug Pugkhanda is selected for the clinical trial in patients of Swetapradara. Ayush PVK gel is another medicine which basically consist of stem barks of five plants mainly Udumbara (Ficus racemosa), Plaksha (Ficus microcarpa) Ashwattha (Ficus religiosa), Nyagrodha (Ficus bengalensis) and Parisha (Thepsia populnea). The aqueous extracts of the above said plants were developed in gel form for local application in vagina. In a previous study conducted by CCRAS in 2012, the vaginal application of PVK gel had similar clinical efficacy as allopathic treatment symptomatically. Therefore, this study plans to find out the efficacy of Pugakhanda & Ayush –PVK gel in the management of Swetapradara (Pathological Leucorrhoea).


 
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