| CTRI Number |
CTRI/2017/12/010947 [Registered on: 21/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
dsyapereunia
female sexual dysfunction |
|
Scientific Title of Study
|
An open clinical trial to evaluate the effect of Yonipichu with Dhanvantara taila in Paripluta Yonivyapat wsr to Dyspareunia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNamrataBBhagaje |
| Designation |
Post Graduate |
| Affiliation |
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI |
| Address |
#65/8 Bhandur galli
Belagavi
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI
Belgaum
KARNATAKA
590002
India |
| Phone |
7204727997 |
| Fax |
|
| Email |
bnamratabhagaje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata bhagaje |
| Designation |
READER DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI |
| Address |
#65/8 bhandur galli belgaum 590002
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI
Belgaum
KARNATAKA
590006
India |
| Phone |
7204727997 |
| Fax |
|
| Email |
bnamratabhagaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNamrataBBhagaje |
| Designation |
Post Graduate |
| Affiliation |
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI |
| Address |
#65/8 Bhandur galli
Belagavi
KLEUS SHRI BMK AYURVEDIC MAHAVIDYALAYA PG AND RESEARCH CENTRE SHAHPUR BELAGAVI
Belgaum
KARNATAKA
590002
India |
| Phone |
7204727997 |
| Fax |
|
| Email |
bnamratabhagaje@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE University’s Shri.B.M.Kankanawadi Ayurveda Mahavidyalaya, PG Studies & Research Centre,
Belgavi Karnataka
|
|
|
Primary Sponsor
|
| Name |
drnamratabbhagaje |
| Address |
#65/8
bhandur galli
belagavi 590002 |
| Type of Sponsor |
Other [self sponsored ] |
|
|
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 |
| DrNamrata b bhagaje |
KLEU SHRI BMK AYURVEDA MAHAVIDYALAYA, PG STUDIES AND RESEARCH CENTRE AND HOSPITAL |
SHAHAPUR 590003
Belgaum
KARNATAKA |
7204727997
bnamratabhagaje@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 |
FEMALE COMPLAINING OF PAIN DURING THE SEXUAL INTERCOURSE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DHANVANTARA TAILA |
DHANVANTARA TAILA IN YONI PICHU FORM 30ml 7 days daily once |
| Comparator Agent |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pain during the intercourse
2. Dry vagina
3. Failure of orgasm
4. Married female patients of sexually active group 20- 45yrs
|
|
| ExclusionCriteria |
| Details |
1. Tough imperforate hymen
2. Narrow introitus
3. Pregnancy
4. Known cases of Benign and malignant condition of cervix
5. Known cases of Veneral diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in pain during intercourse according to VAS scale
2.Increase in number of sexual intercourse weekly |
1.Reduction in pain during intercourse according to VAS scale
2.Increase in number of sexual intercourse weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
15/02/2017 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Above study is an open clinical single group study in patients with mentioned complaints in between age group of 20-45yrs, who will undergo treatment of yonipichu with dhanvantara taila 30ML for 7 days with follow up after 15days of treatment . At the end of the treatment after 15days 1.Pain 2. Dry vagina 3. Frequency of intercourse will be assessed |