| CTRI Number |
CTRI/2022/07/043766 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of constipation in children |
|
Scientific Title of Study
|
Clinical study on the effectiveness of Triphala Arka in children with Vibandha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sawant Diksha Gurudas |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Room no. 16,Department of Kaumrabhritya,
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8888938183 |
| Fax |
|
| Email |
dikshasawant22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja Uppinakuduru |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Room no. 16,Department of Kaumrabhritya,
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja Uppinakuduru |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Room no. 16, Department of Kaumarabhritya,
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
rao.shaila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan |
| Type of Sponsor |
Private medical college |
|
|
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 Sawant Diksha Gurudas |
SDM College of Ayurveda and Hospital |
Room No.16, Department of Kaumarabhritya, Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA |
8888938183
dikshasawant22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triphala Arka |
3ml thrice daily before food for 2 to 4 years and 5ml thrice daily before food for 5 to 6 years |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. The children of either gender between the age group of 2 to 6 years fulfilling the diagnostic criteria of vibandha
2. Children whose parents are willing to participate them in the study by giving informed parent consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of evacuation of stools and Nature of evacuation using ROME IV criteria |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nature of stools assesses using BRISTOL STOOL CHART |
15 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)
|
15/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dikshasawant22@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2025?
Response (Others) - One year post publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The objective of the study is to evaluate the effectiveness of Tripahala Arka in the management of Vibandha in children. 30 children with Vibandha will be administered with Triphala Arka in stipulated dose for a period of 15 days. The assessment will be done using ROME IV criteria. |