| CTRI Number |
CTRI/2023/11/060337 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the efficacy of digestive enzymes, carminatives & probiotics in the management of infantile colic |
|
Scientific Title of Study
|
To evaluate the efficacy of digestive enzymes, carminatives & probiotics in the management of infantile colic in a tertiary care hospital in South India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. G. Raj Kamal |
| Designation |
Post Graduate |
| Affiliation |
Chengalpattu medical college and Hospital |
| Address |
Room no 13
First floor
Block 36 C
PG mens hostel
Chengalpattu medical college and Hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9789226685 |
| Fax |
|
| Email |
rajkamalgrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vijayarani |
| Designation |
Professor and HOD |
| Affiliation |
Chengalpattu medical college |
| Address |
Department of Pharmacology
Chengalpattu medical college
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9444728805 |
| Fax |
|
| Email |
vijayapaed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. G. Raj Kamal |
| Designation |
Post Graduate |
| Affiliation |
Chengalpattu medical college and Hospital |
| Address |
Room no 13
First floor
Block 36 C
PG mens hostel
Chengalpattu medical college and Hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9789226685 |
| Fax |
|
| Email |
rajkamalgrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tablets India Ltd
4th floor
Jhaver Centre’s R.A Building
72 Marshall’s road
Chennai
600008 |
|
|
Primary Sponsor
|
| Name |
Jhaver Research Foundation |
| Address |
4th floor Jhaver Centre’s R.A Building 72 Marshall’s road Chennai 600008 |
| Type of Sponsor |
Research institution |
|
|
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 G Raj Kamal |
Chengalpattu medical college and Hospital |
Paediatric OPD
Department of Paediatrics
Chengalpattu medical college and Hospital
GST Road
Chengalpattu
603001
Kancheepuram
TAMIL NADU |
9789226685
rajkamalgrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Chengalpattu Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of Probiotic, Digestive enzymes Carminatives
(Tummy soft drops) |
Each 5 ml contains
Bacillus coagulans 500 million
GBI-30, 6086
Alpha Amylase (1:800) 25mg
Pepsin (1:3000) 10mg
Lipase (1:15000) 1.5mg
Excipients Q.S
Duration : 5 days
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Infants (age 3 months to 1 year) fulfilling the Rome-IV diagnostic criteria for infantile colic with no evidence of acute/ chronic illness.
2. Rome-IV diagnostic for clinical research purposes, diagnosis of infantile colic also includes both of the following.
3. Caregiver reports infant has cried or fussed for three or more hours per day during three or more days in 7 days in a telephone or face-to-face screening interview; and
4. Total 24-h crying plus fussing in the selected group of infants is confirmed to be three h or more when measured by at least one prospectively kept 24-h behaviour diary.
5. Parents who report their infant crying excessively must be screened on an outpatient basis. |
|
| ExclusionCriteria |
| Details |
1. Infants born before completing 34 weeks of gestation or birth weight < 2500 g and inadequate weight gain (< 125 g/wk.).
2. Infants with known gastrointestinal disorders, previous abdominal surgery, known galactosemia or diabetes mellitus will be excluded from the study.
3. Infants with severe dehydration.
4. Presence of systemic infections.
6. Infants with known immunocompromising morbidities.
7. Infants with severe acute malnutrition.
8. Infants with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.
9. Infants with cystic fibrosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After a 5-day study, the primary outcome will be assessed by the clinical response which is defined as the percentage of infants achieving a reduction in the daily average crying time 50% |
5-days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. After a 5-day study, the secondary outcome will be assessed by the occurrence of adverse events (Milk regurgitation, vomiting, diarrhoea, constipation) following the administration of digestive enzymes, carminatives & probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow.
Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the dairy |
after 5 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study titled “ To evaluate the efficacy of digestive en, carmanatives & Probiotics in the management of infantile colic in a Tertiary care hospital in South India†is Terminated and recruitment not done. Reason: The sponsor insisted on sharing of raw data for publication which can promote the product (which turns it as regulatory trial). The IEC of Chengalpattu medical college is registered for conducting of Academic trials only. |