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
|
|
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
|
|
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). |