| CTRI Number |
CTRI/2023/11/059581 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study effect of Amylase Rich Food in children with diarrhea |
|
Scientific Title of Study
|
Effectiveness of Amylase Rich Food in children with diarrhea |
| 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 Shalaka Prabhakar Patil |
| Designation |
Associate Professor, Pediatrics |
| Affiliation |
BJMC ,Pune |
| Address |
Byramjee Jeejeebhoy Medical College, 11 Storey building, second floor, Department of Pediatrics, Pune
Byramjee Jeejeebhoy Medical College,11 Storey building, second floor, Department of Pediatrics, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
07738085484 |
| Fax |
2026126868 |
| Email |
healthforall2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalaka P Patil |
| Designation |
Associate Professor, Pediatrics |
| Affiliation |
BJMC ,Pune |
| Address |
Byramjee Jeejeebhoy Medical College,11 Storey building, second floor, Department of Pediatrics, Pune
Byramjee Jeejeebhoy Medical College,11 Storey building, second floor, Department of Pediatrics, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
07738085484 |
| Fax |
2026126868 |
| Email |
healthforall2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Arvind Bhagat |
| Designation |
Junior Resident, Pediatrics |
| Affiliation |
BJMC ,Pune |
| Address |
Byramjee Jeejeebhoy Medical College, 11 Storey building, second floor, Department of Pediatrics, Pune
Byramjee Jeejeebhoy Medical College,11 Storey building, second floor, Departments of Pediatrics, Pune.
Pune
MAHARASHTRA
411001
India |
| Phone |
7083886988 |
| Fax |
2026126868 |
| Email |
bhagatsonali555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Byramjee Jeejeebhoy medical college, Sassoon General hospital 411001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NA] |
|
|
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 Shalaka P Patil |
Sassoon General Hospital |
Byramjee Jeejeebhoy medical college, Jai Prakash Narayan Road, near railway station,11 Storey building, second floor, department of pediatrics, Pune
Pune
MAHARASHTRA |
07738085484
2026126868
healthforall2020@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE B.J.Govt.Medical College and Sassoon General Hospital,Pune 1 and Sassoon General Hospital ,Pune |
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 |
| Intervention |
Amylase Rich Food prepared from Finger millet (Ragi). |
S.P formula will be given. Which will be prepared as follows:
To 70ml of purified filtered water 10 Gms of puffed rice powder will be added in a steel vessel. After bringing this mixture to a boil at 100 degrees Celsius for 30 sec on an induction heater 10 Gms of jaggary will be added and brought to a boil at 100 degrees Celsius for 30sec.The vessel will be removed down from heater and cooled down for 30sec by stirring. To this 7 Gms of Amylase Rich Food powder prepared from Finger millet (Ragi) will be added. It will be stirred for 2mins till mixture liquefies. Then it will be given to children with diarrhea. It will be ensured that S.P formula is consumed within 2 hours of its preparation. Along with this WHO protocol of diarrhea and dehydration treatment will be followed for all children. This S.P. formula will be given till symptoms of diarrhea subsides. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
Children of age 7 months to 36 months with diarrhea. |
|
| ExclusionCriteria |
| Details |
Children requiring ventilatory support. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes will be frequency and volume of diarrhea episode experienced by children in each group. |
Till resolution of diarrhea. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcomes will include weight gain by children, time to first formed stools, acceptability of daily feeds and overall well-being |
Till resolution of diarrhea. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 1 |
|
Date of First Enrollment (India)
|
12/11/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The question always remains what more can be done to treat children with diarrhea. Some superfoods which would remove toxin from gut, decreases damage to gut mucosa, aid in healing and promote gut regeneration. Challanges of treating dehydration have been overcome with WHO guidelines. Food availability in resource poor setting is of major concern. While food acceptability and palatability are of concern to primary caregiver of child. To overcome above obstacles, Ragi based Amylase Rich Food was selected in present study. All infant and young children with diarrhea would be given treatment for dehydration and diarrhea as per WHO protocol while 50% of cases would be given in addition S.P. formula. S.P. formula would be made as follows. To 70ml of portable drinking water ,10Gms of puffed rice powder would be added, mixture will be boiled at 100 degrees Celsius for 30 secs on induction heater, to this 10Gms jaggery will be added and again mixture will be boiled at 100 degrees Celsius or 30secs. Vessel will then be removed from the heater and stirred for 30sec. To this 7Gms of Ragi based Amylase Rich Food will be added. In sometime mixture starts liquifying, releasing a pleasant aroma. This S.P. formula will be given to treatment group. Effect will be studied with respect to following. Effect on frequency and duration of diarrhea, consistency of stool, acceptability of feeds, effect on weight gain in child, appearance of any complication and duration of hospital stay, duration of injectable therapy(antibiotics/fluid) . The above mentioned S.P. formula is going to be prepared at Nutritional Rehabilitation Centre, Sassoon hospital under aseptic and hygienic condition.
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