| CTRI Number |
CTRI/2019/04/018562 [Registered on: 11/04/2019] Trial Registered Prospectively |
| Last Modified On: |
10/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Indrayava choorna and Aamalaki choorna in the management of white discharge. |
|
Scientific Title of Study
|
A Randomized controlled clinical study of Indrayava choorna and Aamalaki choorna in the management of Shwetpradara. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Kalyan Kotwal |
| Designation |
PG Student BAMS MS |
| Affiliation |
PDEAs College of Ayurveda And Research Centre |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
|
| Fax |
|
| Email |
priyankakotwal72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Vijay jadhav |
| Designation |
Hod and Guide (Stree rog and Prasuti tantra) department |
| Affiliation |
PDEAs College of Ayurveda And Research Centre |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Kalyan Kotwal |
| Designation |
PG Student BAMS MS |
| Affiliation |
PDEAs College of Ayurveda And Research Centre |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
|
| Fax |
|
| Email |
priyankakotwal72@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayurved And Research Centre Akurdi PUNE Nigdi Pradhikaran Sector 25 |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pune |
| Address |
Nigdi Pradhikaran sec.no 25 Akurdi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Priyanka Kotwal |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi |
OPD NO.119 Bhel Chowk Nigdi Pune 44
Pune
MAHARASHTRA |
7350749942
priyankakotwal72@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: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aamalaki Choorna |
Aamalaki choorna 5 gm BD with sita anupana orally for 1 month. |
| Intervention |
Indrayava Choorna |
Indrayav Choorna 2 gm BD with sita anupana orally for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient having lakshanas of shwetapradara.
2.Married women.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating mothers.
2.Known case of any other pelvic pathology or other pathology like T.B., carcinoma or congenital deformities of reproductive tract.
3.Known case of IDDM.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Indrayava choorna and Aamalaki choorna in the management of Shwetapradara. |
1 Month With Follow up on 7th,15th and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study The Adverse Effect If Any |
1 month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/04/2019 |
| 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="1"
Months="0"
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
|
This study is randomized clinical study parallel group comparing efficacy of Indrayava choorna 2gm twice a day and Aamalaki choorna 5gm twice a day for 1month in 70 patients with leukorrhea. |