| CTRI Number |
CTRI/2019/04/018709 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
22/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of Yastimadhu churna and Nagkeshar churna in the management of Raktapradara.(Excessive vaginal bleeding) |
|
Scientific Title of Study
|
A Randomized controlled clinical study of Yastimadhu churna and Nagkeshar churna in the management of Raktapradara. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Bhimrao Bhowate |
| Designation |
PG Student BAMS MS |
| Affiliation |
PDEAs COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurveda and Reaserch Centre sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital sector 27 Nigdi Pradhikaran Pune 44.
Pune
MAHARASHTRA
411044
India |
| Phone |
8806682808 |
| Fax |
|
| Email |
prachibhowate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayak Shinde |
| Designation |
Guide M.S. (Ayu.) Asso. Profeser (Dept.of Prasuti Tantra & Stri Roga) |
| Affiliation |
PDEAs COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurveda and Reaserch Centre sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital sector 27 Nigdi Pradhikaran Pune 44.
Pune
MAHARASHTRA
411045
India |
| Phone |
9850933512 |
| Fax |
|
| Email |
drvkshinde@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Bhimrao Bhowate |
| Designation |
PG Student BAMS MS |
| Affiliation |
PDEAs COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurveda and Reaserch Centre sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital sector 27 Nigdi Pradhikaran Pune 44.
Pune
MAHARASHTRA
411044
India |
| Phone |
8806682808 |
| Fax |
|
| Email |
prachibhowate@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved And Reasearch 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 |
| Prachi Bhowate |
Dr Prachi Bhimrao Bhowate |
OPD NO. 119 BHEL CHOWK NIGDI PUNE 44
Pune
MAHARASHTRA |
8806682808
prachibhowate@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 |
Nagkeshar churna |
Nagkeshar churna 3gm BD is prepared by punkeshar(Dried stamen of mesua ferrea) as per ayurved text. |
| Intervention |
Yastimadhu churna |
Yastimadhu churna 3gm BD is prepared by yastimadhu root as per ayurved text. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient having lakshanas of raktapradara |
|
| ExclusionCriteria |
| Details |
Known case of hypertesion.
known case of severe anemia.
known case of fiboid ,uterine cancer,genital tuberculosis.
Patient on harmonal replacement therapy. |
|
|
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 Yastimadhu churna and Nagkeshar churna in the managment of Rakt-pradara. |
follow up for 3 months on 7th day of Menses in 3 cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effectif any. |
3 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)
|
20/05/2019 |
| 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 Yastimadhu churna 3 gm twice a day and Nagkeshar churna 3 gm twice a day for 3 month in 70 patient of Rakt-pradara. |