| CTRI Number |
CTRI/2022/06/043338 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of vyoshadi kwath in granthibhutha aartav dushti |
|
Scientific Title of Study
|
Clinical study of vyoshadi kwath in granthibhutha aartav dushti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vasudha prakash khatake |
| Designation |
PG Scholar Streerog and Prasutitantra |
| Affiliation |
Annasaheb dange ayurved medical college and pg research centre,Ashta |
| Address |
Annasaheb dange ayurved medical college and pg research centre Ashta tal walawa dis sangali
At post ashta tal walawa dis sangali
Sangli
MAHARASHTRA
416302
India |
| Phone |
9975543447 |
| Fax |
|
| Email |
vasudhakhatake7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Vitthal Katare |
| Designation |
Guide and HOD |
| Affiliation |
Annasaheb dange ayueved medical college and pg research centre,Ashta |
| Address |
Annasaheb dange ayurved medical college and pg research centre Ashta tal walawa dis sangali
Sangli
MAHARASHTRA
416302
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vasudha prakash khatake |
| Designation |
PG Scholar Streerog and Prasutitantr |
| Affiliation |
Annasaheb dange ayurved medical college and pg research centre,Ashta |
| Address |
Annasaheb dange ayurved medical college and pg research centre Ashta tal walawa dis sangali
At post ashta tal walawa dis sangali
Sangli
MAHARASHTRA
416302
India |
| Phone |
9975543447 |
| Fax |
|
| Email |
vasudhakhatake7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Annasaheb Dange Ayurved Medical college and PG Research centre,Ashta |
|
|
Primary Sponsor
|
| Name |
vasudha prakash khatake |
| Address |
Annasaheb dange ayurved medical college and pg research centre ashta tal walawa dis sangali |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vasudha Prakash Khatake |
Shri Annasaheb Dange Ayurveda Medical College |
Shri Annasaheb Dange Ayurveda Medical College and P G Research Centre Ashta Tal- Walwa Dist-Sangali 416301
Sangli
MAHARASHTRA |
9975543447
vasudhakhatake7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi kwath , Reference: Ashtanga hrudya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Complaining of blood clots of associated with lower abdomen pain and backache during menstrual cycle.
2) Any of above age group female who is having regular three to five days menses in between 28 -35days for last two year |
|
| ExclusionCriteria |
| Details |
1) Patient with systemic disorders like diabetes mellitus, hypertension ,renal disorder, cardiac disorder . 2)patient having palpable pathology of uterus like fibroid , polyp, malignancy ,thyroid disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of vyoshadi kwath in garanthibhutha aartav |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review Literature of Granthibhuta aartav |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2022 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I am Vasudha prakash khatake PG Scholar Streerog and Prasuti-tantra trying to evaluate the efficacy of Vyoshadi kwath in Granthibhuta aartav dusthi .During this trial trying to evaluate untoward effect of vyoshadi kwath in Granthibhuta aartav dusthi as there is no previous work done on vyoshadi kwath. So emphasis will be made to find out easy, cost effective method to control clots in meneses with no side effects. |