| CTRI Number |
CTRI/2017/04/008440 [Registered on: 28/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
SHAYYAMUTRA & its management and prevention |
|
Scientific Title of Study
|
A STUDY ON THE EFFICACY OF ASVAGHANDHADI COMPOUND (ANUBHUT) IN THE MANAGMENT OF SHAYYAMUTRA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHARGAV MEHTA |
| Designation |
MD SCHOLAR |
| Affiliation |
parul institute of ayurved |
| Address |
Department of Kaumarabhritya,Room No 12
PARUL INSTITUTE OF AYURVED
WADHODIA,LIMBDA,VADODARA
Department of Kaumarabhritya,Room No 12
PARUL INSTITUTE OF AYURVED
WADHODIA,LIMBDA,VADODARA
Vadodara
GUJARAT
390025
India |
| Phone |
9428088841 |
| Fax |
|
| Email |
bhargavmehta49@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL P CHANGLE |
| Designation |
ASSO.PROFESSOR |
| Affiliation |
parul institute of ayurved |
| Address |
Department of Kaumarabhritya,Room No 12
Parul Institute OF Ayurved
Waghodia,Limbda,Vadodara
Department of Kaumarabhritya,Room No 12
Parul Institute OF Ayurved
Waghodia,Limbda,Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIL P CHANGLE |
| Designation |
ASSO.PROFESSOR |
| Affiliation |
parul institute of ayurved |
| Address |
Department of Kaumarabhritya,Room No 12
Parul Institute OF Ayurved
Waghodia,Limbda,Vadodara
Department of Kaumarabhritya,Room No 12
Parul Institute OF Ayurved
Waghodia,Limbda,Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL INSTITUTE OF AYURVED
WAGHODIA,BARODA |
| 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 Bhargav Mehta |
parul institute of ayurved |
Department of Kaumarabhritya,Room No 12
Parul Institute OF Ayurved
Waghodia,Limbda,Vadodara
Vadodara
GUJARAT |
9428088841
bhargavmehta49@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved Ethics Committee on Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
SHAYYAMUTRA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASVAGHANDHADI COMPOUND |
2 TAB EACH OF 500 MG TWICE DAILY FOR 60 DAYS AS TREATMENT GROUP |
| Comparator Agent |
BRAHMI TAB |
2 TAB EACH OF 500 MG TWICE DAILY FOR 60 DAYS AS CONTROL GROUP |
| Intervention |
PLACEBO CAPSULE WITH MEDICAL COUNSELLING |
1 CAP EACH OF 250 MG TWICE DAILY FOR 60 DAYS AS TREATMENT GROUP |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
cardinal features of shayyamutra without daytime incontinance,repeated voiding of urinein bed or clothes at least 2-3 times in a week |
|
| ExclusionCriteria |
| Details |
disorders like TB,DM,urinary tract infection ,congenital anomalies,anatomical defect of genitourinary system,neurological disorders like cerebral palsy,mental retardation,spina bifida |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Asvaghandhadi Compound is more effective than Brahmi Vati & placebo group |
Asvaghandhadi Compound is more effective than Brahmi Vati & placebo group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bedwetting controlled |
Till Present study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
06/09/2016 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomised clinical study to evaluate the effect of asvagandhadi compound & brahmi vati on shayyamutra .Routine blood,urine and stool examination will be performed to rule out systemic pathology |