| CTRI Number |
CTRI/2019/07/020104 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dhoopan or Fumigation in Itching vulva |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to evaluate efficacy of Yonidhoopan by Bruhatiphal-Haridradway in management of Yonikandu in relation to Vulvovaginitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANITA |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayuveda |
| Address |
Stri Roga and Prasuti Tantra Department All India Institute of Ayurvada Gautampuri Saritavihar New Delhi 110076
R6 Old Uttam Nagar Near West Uttam Nagar Metro Station New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
7042267767 |
| Fax |
|
| Email |
verma.anita678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sujata Kadam |
| Designation |
HOD Stri Roga & Prasuti Tantra & Dean Academic |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Stri Roga and Prasuti Tantra Department Room No 401 All India Institute of Ayurveda Gautampuri Saritavihar New Delhi 110076
Dean Office Ground floor Academic C Block All India Institute of Ayurveda Gautampuri Saritavihar New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9818294577 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANITA |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Stri Roga and Prasuti Tantra Department All India Institute of Ayurveda Gautampuri Saritavihar New Delhi 110076
R6 Old Uttam Nagar Near West Uttam Nagar Metro Station New Delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
7042267767 |
| Fax |
|
| Email |
verma.anita678@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Gautampuri Saritavihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Gautampuri Saritavihar New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anita |
All India Institute of Ayurveda |
OPD No 203 2nd Floor Stri roga Prasuti Tantra Department Hospital Block
Saritavihar New Delhi 110076
South
DELHI |
7042267767
verma.anita678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
V-Gel for local application in vulvovaginal region twice a day for 7 days in Management of Yonikandu in Vulvovaginitis |
Control group include 33 patients in which V Gel is applied in vulvovaginal region twice daily for 7days |
| Intervention |
Yonidhoopan by Bruhatiphal Haridradway in Management of yonikandu in vulvovaginitis |
Trial group include 33 patients for Yonidhoopan by bruhatiphal Haridradway twice a day for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married woman
Age 20 to 40 years
Clinical sign symptoms of vulvovaginitis that is itching pain in vulvovaginal region redness scratch marks
Microscopically positive specimen for Candida albicans Trichomonas Monoliasis E coli |
|
| ExclusionCriteria |
| Details |
Pregnant women
Immuno compromised patients
Suspected cases of carcinoma of cervix endometrial carcinoma
Known case of Asthma
Tuberculosis positive
Senile vaginitis
Systemic illness like Diabetes mellitus Severe Anaemia Liver disorder Hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce pruritis or itching in vulvovaginal region |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Bacterial flora of vulvovaginitis that is Candida vaginitis Trichomonas vaginalis Monilial E.coli Bacterial vaginosis
To reduce pain redness scratch marks |
1 month |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2019 |
| Date of Study Completion (India) |
27/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, open labelled, parallel group study to evaluate the efficacy of Yonidhoopan by Bruhatiphal Haridradway in management of Yonikandu in relation to Vulvovaginitis compared with individuals receiving V-Gel for local application. This study involves 66 patients divided 33each into Trial and Control Group. Trial Group is receiving Yonidhoopan twice a day for 7days by Bruhatiphal-Haridradway churna. Control Group is receiving V-Gel for local application twice a day for 7days. Follow up will be done on 10th and 14th day. Primary outcome of the study is to reduce itching in vulvovaginal region. Secondary outcome is to reduce the bacterial flora of vulvovaginitis that is Candida vaginitis, Trichomonas vaginalis, Monilial, E.coli, Bacterial vaginosis and also to reduce pain, redness, scratch marks. |