CTRI Number |
CTRI/2020/03/023744 [Registered on: 03/03/2020] Trial Registered Prospectively |
Last Modified On: |
27/06/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Managment of vaginal bleeding by ayurvedic medicine and procedure |
Scientific Title of Study
|
MANAGEMENT OF ASRIGDARA (AUB) BY VIRECHANA AND VASADI CHURNA: A RANDOMIZED COMPARATIVE CLINICAL STUDY |
Trial Acronym |
AUB |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
ANKIT KUMAR GARG |
Designation |
RESEARCH SCHOLAR |
Affiliation |
IPGT AND RA GAU JAMNAGAR |
Address |
OPD NO 1 DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY OPPOSITE CITY B DIVISION POLICE STATION JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
8302463471 |
Fax |
|
Email |
drankitgarg111@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
PROF LAXMIPRIYA DEI |
Designation |
professor |
Affiliation |
IPGT AND RA GAU JAMNAGAR |
Address |
5TH FLOR DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA IPGT AND RA HOSPITAL JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
9106943729 |
Fax |
|
Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
PROF LAXMIPRIYA DEI |
Designation |
professor |
Affiliation |
IPGT AND RA GAU JAMNAGAR |
Address |
DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA 5TH FLOR IPGT AND RA GUJRAT AYURVED UNIVERSITY JAMNAGAR Jamnagar GUJARAT 361008 India |
Phone |
9106943729 |
Fax |
|
Email |
deilaxmipriya@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
IPGT AND RA GAU JAMNAGAR |
Address |
IPGT AND RA GAU JAMNAGAR OPPOSITE B DIVISION POLICE STATION JAMNAGAR |
Type of Sponsor |
Research institution and hospital |
|
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 |
ANKIT KUMAR GARG |
IPGT AND RA PG HOSPITAL |
OPPOSITE CITY B DIVISION POLICE STATION JAMNAGAR Jamnagar GUJARAT |
8302463471
drankitgarg111@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: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
VIRECHANA |
Group A patients will be administered Virechana drug using Trivruta Avaleha 80 to 100 gm followed by Vasadi Churna 3 gm 6 hourly during bleeding 3 gm bd after bleeding orally with Anupana of Madhu for 60 dyas |
Comparator Agent |
VASADI CHURNA |
Group B patients will be treated with Vasadi Churna 3 gm 6 hourly during bleeding 3 gm bd after bleeding orally with Anupana of Madhu for 60 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
Patients having any one or two of the following features will be included
Ayurvedic features of Asrigdara
Modern features
Excessive bleeding
Prolonged duration
Intermenstrual bleeding
Bleedinng due to other cause
Patients who are Yogya for Virechana
The quantity of bleeding will be decided by complete soaked number of pads and using thickened pads
|
|
ExclusionCriteria |
Details |
Age below 18 and above 50 years
Bleeding due to Erosion cancer fibroid and Polyp
Bleeding followed by abortion
Bleeding from the site other than the uterus
Coagulation disorders
Suffering from malignancies and chronic systemic diseases like, uncontrolled hypertension (Systolic blood pressure above 180 & Diastolic blood pressure above 120mmhg) uncontrolled diabetes (above the range of 160-200 mg/dl (RBS) Veneral disease
Patients who are Ayogya for Virechana
Post menopausal bleeding
Hb% <7 |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
cure of asrigdara |
4 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Relief in bleeding as compare to previous |
4 month |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
05/03/2020 |
Date of Study Completion (India) |
20/05/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This was
an open-labelled, comparative parallel-group study in the management of Asrigdara.
In this trial total of 38 patients were enrolled, 34 patients completed the
treatment, and follow-up, 4 patients were dropped out. In Group A 17 patients had been prescribed Virechana and Vasadi
Churna 3 gm 6 hourly during bleeding and 3gm BD
after bleeding and in Group B, 17 patients had been prescribed
the Vasadi Churna 3gm 6 hourly during bleeding and 3gm BD after
bleeding for 60 days. After the completion of the treatment protocol,
the follow-up period was 1 month for both groups to assess the difference in the consecutive
menstrual cycle. The assessment was done based on signs
and symptoms i.e., Excessive Bleeding, Prolonged duration
bleeding, Intermenstrual Bleeding, Bleeding with clots and associated
complaints like Vedana, Angamarda, Panduta, Daurbalya, Daha,
Bhrama. Results: In the Overall effect of therapy, percentage relief in Group A was
89.30% while in Group B it was 74.93%. In Group A 47.05% of patients got complete
remission and 35.30% of patients were found to marked improvement. While 17.65%
were found to moderate improvement, no patient was found Mild improvement and
remained unchanged. In Group B 5.88% of patients got complete remission and
41.17% of patients found marked improvement. While 47.05% of patients got
moderate improvement, 5.88% got Mild improvement and no patient remained
unchanged. This data shows that Virechana with Vasadi Churna Group
(Group A) is better than Vasadi Churna Group (Group B).
So, analysing the data obtained from the present study, the null hypothesis
i.e., Virechana followed by Vasadi Churna is
not effective than that of Vasadi Churna alone in the management
of Asrigdara (AUB)) has rejected and the alternate hypothesis
i.e., Virechana followed by Vasadi Churna (Group
A) is more effective than Vasadi Churna alone (Group B) in the
management of Asrigdara (AUB)) has accepted.
|