| CTRI Number |
CTRI/2015/07/006037 [Registered on: 20/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial being conducted in children complaining of irregular menstrual cycle and related issues |
|
Scientific Title of Study
|
A FURTHER CLINICAL STUDY ON GRAHANI DOSHA AND ITS MANAGEMENT WITH DEVDARVYADI VATI AND BHUNIMBADI VATI IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MALEKA RAISBHAI VHORA |
| Designation |
MD SCHOLAR |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR |
| Address |
PG GIRLS HOSTEL ROOM NO 09 IPGT AND RA GUJARAT AYURVED UNIVERSITY JAMNAGAR
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
09033564992 |
| Fax |
|
| Email |
maleka23vhora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S PATEL |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR |
| Address |
Dept of Kaumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
GUJARAT
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
09427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAJAGOPALA S |
| Designation |
ASSISTANT PROFESSAR |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR |
| Address |
Dept of Kaumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
GUJARAT
Institute for Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
09409207548 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar 361008
|
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar 361008
GUJARAT |
| 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 |
| Dr MALEKA RAISBHAI VHORA |
Institute for Post Graduate Teaching and Research in Ayurveda |
Department of Kaumarbhritya Institute for Post Graduate Teaching and Research in Ayurved GAU Jamnagar
Jamnagar
GUJARAT |
09033564992
maleka23vhora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute for Post Graduate Teaching and Research in Ayurved GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Irregular Mala Pravritti , Udarashula , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A DEVDARVYADI VATI |
DOSE 3gm ,3.5gm,4gm,5gm,5.5gm,6gm (As per age)
Dosage form: Vati(Each Vati is of 500 mg)
Duration : 4 Weeks
Route of administration:Oral,
Time of administration:Adhobhakta,
Anupana :Sukhoshna jala,
Follow up :4 Weeks |
| Intervention |
Group:B BHUNIMBADI VATI |
DOSE 3gm ,3.5gm,4gm,5gm,5.5gm,6gm (As per age) Dosage form: Vati(Each Vati is of 500 mg) Duration : 4 Weeks,
Route of administration :Oral,
Time of administration:Adhobhakta ,Anupana :Sukhoshna jala ,Follow up :4 Weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
(Any two or more among it)
1)Age : 5 -10 years of both sex
2) Irregular Mala Pravritti
3) Udarashula
4) Balakshaya
5) Avipaka |
|
| ExclusionCriteria |
| Details |
1)Age: below 5 years and above 10 years.
2)Having infestation and infectious disease.
3)Congenital anomalies
4)Hereditary diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| On the basis of improvement in the Irregular Mala Pravriti |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
On basis of improvement in the clinical signs and symptoms and investigations
|
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is designed
1) To evaluate the clinical efficacy of Devadarvyadi Vati and Bhunimbadi Vati in Grahani Dosha.
2)To survey for the prevalence of Grahani Dosha in school going children of Jamnagar city.
Group : A DEVDARVYADI VATI
Dose : 3gm,3.5gm,4gm,5gm,5.5gm,6gm (As per age )
Dosage form :Vati (Each vati is of 500mg)
Route of administration :Oral
Time of administration:Adhobhakta
Anupana : Sukhoshna jala
Duration:4 Weeks
Follow up : 4 Weeks
Group : B BHUNIMBADI VATI
Dose : 3gm,3.5gm,4gm,5gm,5.5gm,6gm (As per age )
Dosage form :Vati (Each vati is of 500mg)
Route of administration :Oral
Time of administration:Adhobhakta
Anupana : Sukhoshna jala
Duration:4 Weeks
Follow up : 4 Weeks
|