| CTRI Number |
CTRI/2021/03/031909 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the action of Sukumara ghrita and Harithaki Khanda in constipation in children |
|
Scientific Title of Study
|
comparative clinical study on the effectiveness of sukumara ghrita and harithaki khanda in the management of vibandha in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sonam malik |
| Designation |
post graduate scholar |
| Affiliation |
sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka |
| Address |
department of kaumarabhrithya
sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thanniruhalla hassan karnataka
pon 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9053818750 |
| Fax |
|
| Email |
drsonammalik9053@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Mallannavar |
| Designation |
Associate Professor |
| Affiliation |
sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka |
| Address |
department of kaumarabhrithya
sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thanniruhalla hassan karnataka
pon 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sonam malik |
| Designation |
post graduate scholar |
| Affiliation |
sri dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka |
| Address |
department of kaumarabhrithya
sri dharmasthala manjunatheshwara college of ayurveda and hospital BM road thanniruhalla hassan karnataka
pon 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9053818750 |
| Fax |
|
| Email |
drsonammalik9053@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Dr Sonam Malik |
| Address |
Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| 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 |
| Dr Sonam Malik |
SDM College of Ayurveda and Hospital, Hassan |
Room No.16, Department of Kaumarabhritya, SDM College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA |
9053818750
drsonammalik9053@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: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Harithaki khanda |
2.5gm for 2 to 4years
5gm for 4 to 6 years
for 15 days |
| Intervention |
Sukumara ghrita |
5ml for 2 to 4years
10 ml for 4 to 6 years
both for 15 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either gender within the age of 2 to 6 years
2. Whose parents willing to sign the informed consent |
|
| ExclusionCriteria |
| Details |
1. Hypothyroidism
2. Structural anomalies of anal canal
3. Hirschsorung disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from constipation in 7 days |
Relief from constipation in 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life after 15 days |
Quality of life after 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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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="0"
Days="15" |
|
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-identification.
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 (Others) - Data will be made available on request
- For how long will this data be available start date provided 01-01-2023 and end date provided 31-12-2023?
Response (Others) - One year post publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will be a comparative one where the effectiveness of Sukumara ghrita and Harithaki khanda is assessed in the management of Vibandha (constipation) in children. The total duration of therapy will be for a period of 15 days. |