| CTRI Number |
CTRI/2023/07/055675 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy of complementary Food in Respiratory Health and Overall Well being |
|
Scientific Title of Study
|
Clinical Study to Evaluate the Efficacy of Complementary Food (Kidison) in Respiratory Health and Overall Well-being in Children- Randomized Open Label Clinical Study |
| 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 SUDIP SAHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CHITTARANJAN SEVA SADAN & SISHU SADAN HOSPITAL |
| Address |
CHITTARANJAN SEVA SADAN & SISHU SADAN HOSPITAL
ASSOCIATE PROFESSOR
OPD ROOM NO 5
37 SP MUKHERJEE ROAD BHOWANIPORE KOLKATA
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831112705 |
| Fax |
|
| Email |
sudipsaha1973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSUDIP SAHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CHITTARANJAN SEVA SADAN & SISHU SADAN HOSPITAL |
| Address |
CHITTARANJAN SEVA SADAN & SISHU SADAN HOSPITAL
ASSOCIATE PROFESSOR
OPD ROOM NO 5
37 SP MUKHERJEE ROAD
BHOWANIPORE
KOLKATA
70026
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831112705 |
| Fax |
|
| Email |
sudipsaha1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K SURESH KUMAR |
| Designation |
DIRECTOR |
| Affiliation |
BIOMIICRON PHARMA INDIA PVT LTD |
| Address |
BIOMIICRON PHARMA INDIA PVT LTD
OLD NO 18 NEW NO 32
DR AMBEDKAR ROAD
KODAMBAKKAM
CHENNAI
TAMIL NADU
Chennai
TAMIL NADU
600024
India |
| Phone |
9444102120 |
| Fax |
|
| Email |
smksuresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIOMIICRON PHARMA INDIA PVT LTD
OLD NO 18 NEW NO 32 DR AMBEDKAR ROAD KODAMBAKKAM CHENNAI 600024 |
|
|
Primary Sponsor
|
| Name |
Dr SUDIP SAHA |
| Address |
CHITTARANJAN SEVA SADAN AND SISHU SADAN HOSPITAL
DEPARTMENT OF PEDIATRICS
ASSOCIATE PROFESSOR
OPD ROOM NO 5
37 SP MUKHERJEE ROAD BHOWANIPORE
KOLKATA
700026 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BIOMIICRON PHARMA INDIA PVT LTD |
OLD NO 18 NEW NO 32 DR AMBEDKAR ROAD KODAMBAKKAM CHENNAI
TAMIL NADU 600024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SUDIP SAHA |
CHITTARANJAN SEVA SADAN AND SISHU SADAN HOSPITAL |
DEPARTMENT OF PEDIATRICS
OPD ROOM NO 5
37 SP MUKHERJEE ROAD
BHOWANIPORE
KOLKATA
700026
Kolkata
WEST BENGAL |
9831112705
sudipsaha1973@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHITTARANJAN SEVA SADAN COLLEGE OF OBSTETRICS GYNAECOLOGY AND CHILD HEALTH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMPLEMENTARY FOOD(KIDISON) |
Kidison with rich content of Amylase resistant starch is made with special care of properly selected ingredients like Rice flakes Essential pulses And Zinc |
| Comparator Agent |
NO TREATMENT |
NO TREATMENT WITH NORMAL DIET |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female children in the age group of 2 to 6 years
Subjects who present with mild occasional cold, cough, sore throat, fever, heaviness of head or headache Loss of appetite rhinorrhea sneeze nasal congestion lethargy tiredness or fatigue
Subjects or LAR willing to give written informed consent
Subjects who are willing to maintain their regular diet pattern and refrain from taking any other beverages known to relieve cold& cough
Subjects who have not participated in similar kind of study in last 4 weeks
|
|
| ExclusionCriteria |
| Details |
Subjects with chronic obstructive respiratory disorders, gastrointestinal disorders
Subjects who had undergone any surgery in the recent past
Subjects with chronic upper or lower respiratory tract infection
Subjects who are on any antibiotics anti allergic or anti inflammatory medications
Subjects with established cardio pulmonary disorders hypertension renal or hepatic or cardiac failure
Subjects with endocrine disorders
Subjects currently using prescription medication to treat respiratory conditions
Subjects who are not willing to sign informed consent form
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement as assessed by clinical examination1 Reduction in frequency of URTI 2 Improvement in appetite 3 weight gain 4 reduction in antibiotic usage Assessment will be done on the scale of 0 to 3 0 is nil 1 is mild 2 is moderate 3 is severe The scoring will be in turn correlated with response to the treatment as follows Poor response less than 25 percent reduction Moderate response 25 to 49 percent Good response 50 to74 percent Excellent response 75 percent |
six & nine months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the occurrence of any adverse
To assess events & overall compliance of the subject to the study intervention
|
six & nine months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/08/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
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 (Others) - BASED ON THE REQUEST TO PRINCIPAL INVESTIGATOR TO MAIL AT sudipsaha@gmail.com
- For how long will this data be available start date provided 18-12-2024 and end date provided 18-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This will be a randomized open label clinical
study In this study 120 Subjects who fulfil
the inclusion criteria will be selected and grouped into two groups According
to randomization Group 1 consists of 60 subjects and will receive standard
treatment plus regular diet followed by regular diet for 6 months and follow up for 3 more months after the completion of the
study and Group 2 consists of 60 subjects and will receive standard treatment plus
Kidison one serving of 20 grams two or
three times daily with regular diet followed by Kidison one serving 20 grams
two or three times daily along with their regular diet for 6 months If the results are showing improvement and the study
will be discontinued and the patients will be observed
for next three months 9 months from the start date If the results are not of major improvement then the study will be continued for a further
period of 3 months and the patients will be observed for next three months
12 months from the start date
Follow up visits end of every 3 months
Clinical assessment will be carried out at all scheduled study visits like
before and end of the study period 6 months or at the end of 9 months compared
with baseline and end of the study The severity of the clinical symptoms will
be recorded based on Complete Blood count C reactive
protein and IL 1 Severity of the
clinical symptoms will be recorded based on a scale 0 to 3 where 0 to nil 1 is
mild 2 is moderate 3 is severe Laboratory examination will be carried during
screening and at the end of the study and the values will be compared |