| CTRI Number |
CTRI/2017/03/008095 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
25/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of constipation in children with haritaki khanda |
|
Scientific Title of Study
|
A clinical study on the effect of haritaki khanda in the management of vibandha (constipation) in children aged 3-6 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahana CL |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9482645944 |
| Fax |
918172256464 |
| Email |
sahanavarsha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Kulkarni |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9480478639 |
| Fax |
918172256464 |
| Email |
drreenakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Kulkarni |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9480478639 |
| Fax |
918172256464 |
| Email |
drreenakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
| Type of Sponsor |
Other [Sri Dharmasthala Manjunatheshwara College of Ayurveda 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 Sahana CL |
Dept of kaumarabhritya OPD no 2 Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital
BM ROAD Hassan
Hassan
KARNATAKA |
9482645944
918172256464
sahanavarsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vibandha (constipation), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HARITAKI KHANDA |
HARITAKI KHANDA
6GRAMS TWICE DAILY ORALLY WITH WARM MILK BEFORE FOOD FOR 14 DAYS |
| Comparator Agent |
NONE |
NONE |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1 Children either of both genders between the age group of 03 to 06 years.
2 Children fulfilling the diagnostic criteria of constipation.
3 Parents willing to give assent for the Research study.
|
|
| ExclusionCriteria |
| Details |
1 Children having constipation secondary to any of other disorder like hypothyroidism, hirschprung’s disease and structural anamolies of anal canal will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in the symptom of Vibandha
Improvement in the diagnostic tool Rome III criteria
-for neonates and toddlers --for a child with developmental age of 4 years and above 4 years |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in overall health and nutrition
Improvement in digestion |
28 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)
|
01/04/2017 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open labeled single arm non-randomized prospective clinical trial to study the effect of Haritaki Khanda given at a dose of 6grams bid with warm milk for 14days in children with Vibandha (constipation)and the study will be conducted at Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India. The primary outcome measures will be relief from constipation and improvements in the diagnostic tool ROME III criteria for both Neonates and Toddlers and a child with developmental age of 4years and above 4years respectively at 14day and followed for 28 days to assess the sustained effect of trial drug.
|