| CTRI Number |
CTRI/2025/07/091348 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of honey in acute diarrhea in young children |
|
Scientific Title of Study
|
Effect of honey supplementation in acute diarrhea in children aged 7 months to 5 years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gali Tejaswini |
| Designation |
Junior Resident |
| Affiliation |
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Pediatrics
2nd floor Hospital Building BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8885166685 |
| Fax |
|
| Email |
teju.g8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hidayatullah Bijapure |
| Designation |
Associate Professor |
| Affiliation |
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Pediatrics
2nd Floor Hospital Building
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
9987376749 |
| Fax |
|
| Email |
Hr.bijapure@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Gali Tejaswini |
| Designation |
Junior Resident |
| Affiliation |
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Paediatrics
2nd floor Hospital Building BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8885166685 |
| Fax |
|
| Email |
teju.g8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College, Hospital and Research Centre Bangaramma Sajjan Campus Solapur Road Bijapur 586103 Karnataka State India |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Shri B M Patil Medical College, Hospital and Research Centre Bangaramma Sajjan Campus Solapur Road Bijapur 586103 Karnataka State India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gali Tejaswini |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
Pediatrics ward,
Ward No.401,
Hospital Building
BLDE Deemed to be
University Shri B M Patil
Medical College Hospital and
Research Centre
Bijapur
KARNATAKA
Bijapur
KARNATAKA |
8885166685
teju.g8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE S B M P M C |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORS + Zinc + Honey |
Honey 1.5ml 6th hourly to children aged 1-3 years and 2ml 6th hourly a day to children aged 3-5 years.
Duration of honey : Until recovery or max 5 days |
| Comparator Agent |
ORS + Zinc as per WHO protocol |
With out honey supplementation |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Acute non bloody diarrhea (more than or equal to 3 loose stools per day)
Age between 7 months and 5 years
Mild to moderate dehydration (WHO IMNCI criteria)
Informed parental consent |
|
| ExclusionCriteria |
| Details |
Severe dehydration.
Malnutrition (weight for height Z score less than 3 standard deviation)
H/O Allergy to honey
Underlying immunodeficiency or chronic GI disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration (in hours) from enrolment to last unformed stool |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Daily stool frequency
Stool consistency (Bristol Stool Chart)
Time to recovery (return to normal diet/activity)
Weight gain/loss during illness
Se Na (Hypernatremia or hyponatremia)
Adverse events (Vomiting, Rash)
|
5 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2025 |
| 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)
|
Not Applicable |
| 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
|
Acute diarrhea remains a significant cause of morbidity and mortality in children, especially in low- and middle-income countries. The World Health Organization emphasizes oral rehydration therapy (ORS) and zinc supplementation as cornerstones of management. However, there is a growing interest in adjunctive natural therapies that may improve outcomes. Honey, a natural substance rich in antioxidants, enzymes, and antimicrobial agents, has been used traditionally to treat gastrointestinal illnesses. Studies suggest that honey: · Promotes water and electrolyte absorption in the intestine. · Exhibits bacteriostatic and bactericidal effects against common diarrheal pathogens. · May help reduce the duration, frequency, and severity of diarrhea. Yet, evidence on its clinical use in pediatric acute diarrhea remains limited and underexplored. This study aims to assess the effectiveness of oral honey supplementation as an adjunct to standard therapy in children with acute diarrhea |