| CTRI Number |
CTRI/2024/12/078028 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Short duration treatment of zinc versus conventional zinc therapy in acute diarrhea in children |
|
Scientific Title of Study
|
Comparison of Short Duration Zinc Supplementation with Conventional Zinc therapy in Children with Acute Diarrhea; A Quadruple Blind, Randomized Controlled Trial
|
| Trial Acronym |
ZESC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patlolla Akhila |
| Designation |
Junior Resident(Academic), MD Pediatrics |
| Affiliation |
Junior Resident |
| Address |
Room no:321, 3rd Floor
OPD Block
Department of Pediatrics
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9398366318 |
| Fax |
|
| Email |
akhilapatlolla17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jyothi Naik |
| Designation |
Associate Professor, Department of Pediatrics, AIIMS Mangalagiri |
| Affiliation |
Associate Professor |
| Address |
Room no:321
3rd floor, OPD block
Department of Pediatrics
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9398366318 |
| Fax |
|
| Email |
naikpuja879@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Patlolla Akhila |
| Designation |
Junior Resident(Academic), MD Pediatrics |
| Affiliation |
Junior resident |
| Address |
Room no: 321,
3rd Floor OPD block
Department of Pediatrics
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9398366318 |
| Fax |
|
| Email |
akhilapatlolla17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pediatrics
AIIMS Mangalagiri, Mangalagiri
Guntur District
522503
Andhra Pradesh
India |
| Self funded with institutional support |
|
|
Primary Sponsor
|
| Name |
Patlolla Akhila |
| Address |
Room no:321,3rd floor OPD block,Department of Pediatrics AIIMS Mangalagiri, Guntur, AndhraPradesh, 522503 |
| 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 Akhila Patlolla |
AIIMS Mangalagiri |
Room no: 321, 3rd floor OPD block, Department of Pediatrics
AIIMS Mangalagiri
Mangalagiri
Guntur
Pincode 522503
Guntur
ANDHRA PRADESH |
9398366318
akhilapatlolla17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Zinc sulphate given for 14 days |
Zinc sulphate tablet 20mg given once daily orally for 14 days |
| Intervention |
Zinc sulphate tablet for 7 days followed by placebo tablets for 7 days |
Zinc sulphate tablet 20mg once daily given orally for 7 days after which placebo once daily orally is given for 7 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
children between 6months to 59 months of age who are diagnosed with Acute watery Diarrhea for less than 7 days(Acute watery diarrhea is defined as a change in the consistency of stool leading to loose/liquid stools and/or an increase in the frequency of evacuations to three or more in 24 hours, with or without fever or vomiting lasting 7 days or less |
|
| ExclusionCriteria |
| Details |
1. Children with persistent diarrhea 2. Children who have undergone prior GI surgery/ history of prolonged nutritional therapy/ who has taken prior zinc therapy in last 6 months 3. Children with comorbidities |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| number of episodes of loose stools after treatment |
Days 1,2,3,30,60,90 after treament |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of episodes of vomiting after treatment |
Day 1 ,2,3,30,60,90 after traetment |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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 3 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| 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="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
We are conducting a randomised controlled trial as a part of post graduate thesis programme. Title of the research is "Comparison of Short Duration Zinc Supplementation with Conventional Zinc Therapy in Children with Acute Diarrhea;A Quadruple Blind Randomised Controlled Trial". It is done in the setting of Department of Pediatrics OPD and IPD, AIIMS Mangalagiri. The sample size is 156 participants and duration of study is 18 months.
|