| CTRI Number |
CTRI/2018/05/013722 [Registered on: 07/05/2018] Trial Registered Prospectively |
| Last Modified On: |
16/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect oF syp "Dhatakyadi yoga" In childhood diarrhoea |
|
Scientific Title of Study
|
A clinical study to evaluate the role of "Dhatakyadi yoga" in Balatisara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laxmi |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow Uttar Pradesh |
| Address |
PG deptt of kaumarabhritya state ayurvedic college and hospital lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow Uttar Pradesh |
| Address |
PG deptt of kaumarabhritya state ayurvedic college and hospital lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow Uttar Pradesh |
| Address |
PG deptt of kaumarabhritya state ayurvedic college and hospital lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| state ayurvedic college and hospital and lucknow university Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
state ayurvedic college and hoispital lucknow Uttar Pradesh |
| Address |
state ayurvedic college and hoispital tulsidas marg lucknow Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Dr Laxmi Assistant Professor Deptt of
Kaumarabhritya state ayurvedic hospital and
college lucknow Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Laxmi |
State ayurvedic college and hospital lucknow Uttar Pradesh |
Deptt of kaumarabhritya opd no 2 State ayurvedic college and
hospital tulsidas marg
lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH |
9792446688
lakshmiomsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee State Ayurvedic Post Graduate College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients showing pratyatma lakshana of atisara(diarrhea)i.e.loose stools more than three
times a day, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Single Arm Study trial thus not applicable |
not applicable |
| Intervention |
Syrup Dhatakyadi Yoga |
Administered orally in dose
of 1ml/kg body wt/day in three divided dosage for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children suffering from diarrhea between 2 to 12 year of age(annada)
2. Passage of loose / watery stools more than three times per day
3. Diarrhea with or without sign and symptoms of mild dehydration |
|
| ExclusionCriteria |
| Details |
1.children above the age of 12 years and below 2 years.
2.Children suffering from diarrhea with moderate to severe
dehydration.
3.Children suffering from severe systemic disorders and congenital gastrointestinal anomalies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in frequency and consistency of loose
stool |
2 to 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in pain abdomen
and improvement in loss of appetite |
3 to 7 days |
|
|
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)
|
11/05/2018 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single arm trial to evaluate the efficacy of classically mentioned compound ’dhatakyadi yoga’ in balatisara (childhood diarrhea) on scientific parameter .The study is aimed to conduct trial on 30 patients from OPD and IPD of State Ayurvedic college and hospital Lucknow(U.P.). Study includes children aged between 2 to 12 years. The trial drug will be administered as syrup form in the dose of 1ml/kg body wt/day in 3 divided dosage for 7 days. Primary outcome measures are relief in frequency and consistency of stool in 2 to 4 days while secondary outcome are improvement in appetite and pain in abdomen in 3 to 7 days.The trial is not yet recuited. |