| CTRI Number |
CTRI/2017/11/010377 [Registered on: 06/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of ayurvedic drug compound, Nimbashatak Vati in patient with intestinal worm infestation |
|
Scientific Title of Study
|
Clinical study on the management of krimiroga (intestinal worm infestation) in children with Nimbashatak Vati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh Patel |
| Designation |
P.G.Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Institute of Ayurveda P.O. Limda Tal-Waghodia Dist-Vadodara pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909597376 |
| Fax |
|
| Email |
drmjp007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Changle |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Institute of Ayurveda P.O. Limda Tal-Waghodia Dist-Vadodara pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
Sunilchangle16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh Patel |
| Designation |
P.G.Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Parul Institute of Ayurveda P.O. Limda Tal-Waghodia Dist-Vadodara pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9909597376 |
| Fax |
|
| Email |
drmjp007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurveda Hospital, A/P Limada Tal Waghodia Dist Vadodara Gujarat. |
|
|
Primary Sponsor
|
| Name |
Mahesh Patel |
| Address |
Parul Institute of Ayurveda P.O.Limda Tal-Waghodia Dist-Vadodara Gujarat 391760 |
| 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 |
| Mahesh Patel |
Parul Institute of Ayurvedal |
Kaumarbhritya department in Ayurveda hospital
Vadodara
GUJARAT |
9909597376
drmjp007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurveda-Institutional Ethics Committee on Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
krimi(intestinal worm infestation), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimbashatak vati 500mg |
child dose as per age will be calculated according to youngs formula.
Time of drug administration-at night with luke warm water |
| Comparator Agent |
Tab Albendazole 400mg |
Tab Albendazole 400mg single dose, repeat 400mg dose after 15 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
children with clinical feature of krimiroga and positive stool report for intestinal helminthic infestation (cyst and ova) |
|
| ExclusionCriteria |
| Details |
patient with major congenital disorders and chronic debilitating disease. |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in subsidence of the clinical sign and symptoms with negative stool report for ova and cyst. |
28 days in both intervention and control grroup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in general health condition and quality of life. |
After 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "29"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2016 |
| Date of Study Completion (India) |
10/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized controlled clinical study to evaluate the efficacy of Nimbashatak vati (tablet prepared out of 6 anti-helminthic drugs mentioned in ayurvedic treaties- Yog-Ratnakar) and tab Albendazole in the management of krimi(intestinal worm infestation).The primary outcome measures are changes in subsidence of the clinical sign and symptoms measured at baseline and after 2 week in control group and abscence of recurrence during follow up. Changes in stool report in baseline ,after 4 weeks of intervention, and for 2 times during follow up period will also be conducted to assess the efficacy of treatment to prevent the recurrence. Secondary outcome measures are changes in general health condition like body weight ,Agni bala, Deha bala, Chetas bala at Baseline and after 4 weeks. |