| CTRI Number |
CTRI/2019/10/021772 [Registered on: 23/10/2019] Trial Registered Prospectively |
| Last Modified On: |
19/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of karanj malahar in management of kapaja yonivyapad |
|
Scientific Title of Study
|
Randomised open control study of karanj malahar in management of kapaja yonivyapad |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milind Hirve |
| Designation |
MS Prasutitantra and Streerog |
| Affiliation |
Annasaheb Dange Ayurved Medical college Ashta |
| Address |
Annasaheb Dange Ayurved Medical College and PG research training centre Ashta Dist.Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860582881 |
| Fax |
|
| Email |
drmilindhirave@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Hirve |
| Designation |
MS Prasutitantra and Streerog |
| Affiliation |
Annasaheb Dange Ayurved Medical college Ashta |
| Address |
Annasaheb Dange Ayurved Medical College and PG research training centre Ashta Dist.Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860582881 |
| Fax |
|
| Email |
drmilindhirave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Hirve |
| Designation |
MS Prasutitantra and Streerog |
| Affiliation |
Annasaheb Dange Ayurved Medical college Ashta |
| Address |
Annasaheb Dange Ayurved Medical College and PG research training centre Ashta Dist.Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860582881 |
| Fax |
|
| Email |
drmilindhirave@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon.Shri.Annasaheb Dange Ayurved Medical College Ashta Dist.Sangli Tal.Walwa 416301 |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
| Address |
Annasaheb Dange Ayurved Medical College and PG research training centre Ashta Dist.Sangli |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Zimbabwe
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Prakashrao Dandale |
Hon.Shri. Annasaheb Dange Ayurved Medical College Ashta |
Prasutitantra and streerog department
Sangli
MAHARASHTRA |
9767694357
dandaleshruti7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, (2) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clotrimazole gel |
per vaginal application of clotrimazole gel for 7 days |
| Intervention |
karanj malahar |
per vaginal application of karanj malahar for 7 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
marrisd non pregnant women with regular menstrual cycle having yonigatshwetstrav, yonikandu, alpavedana, gandha. |
|
| ExclusionCriteria |
| Details |
diabetic unmarried pregnant women having STD,Ca,post menopausal condition,cervical erosion,local skin lesion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the efficacy of karanj malahar in kaphaj yonivyapad |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the mode of action of karanja malahar |
7 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/11/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical research project named as Randomised open control study of karanj malahar in management of kaphaj yonivyapad will be conducted with support of Hon.Shri. Annasaheb Dange Ayurved Medical College Ashta.
|