| CTRI Number |
CTRI/2023/03/051017 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Preventive |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Homeopathic prevention for diarrheal disease in children |
|
Scientific Title of Study
|
Efficacy of Homoeopathic interventions Cuprum metallicum 30C and Camphor 30C in preventing childhood diarrhoea at urban slums of Delhi - cluster randomized, double blind, placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer (H)/ Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
9873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer (H)/ Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
9873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer (H)/ Scientist III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri
South West
DELHI
110058
India |
| Phone |
9873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, New Delhi, Ministry of Ayush, Government of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy, under Ministry of Ayush, Government of India |
| Address |
61-65, Institutional area, opp. D-Block Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Debadatta Nayak |
Central Council for Research in Homoeopathy |
Epidemic cell, Room No 303
61-65, Institutional Area, Opp. D Block, Janak Puri, New Delhi – 110058, India
South West
DELHI |
9873404012
drdnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Childhood Diarrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Camphor 30C |
One dose (4 pills) per week will be given to children for initial 2 months after enrollment, thereafter one dose (4 pills) fortnightly for next 2 months (3rd & 4th month) and subsequently one dose (4 pills) per month for last 20 months (5th – 24th month). |
| Intervention |
Cuprum metallicum 30C |
One dose (4 pills) per week will be given to children for initial 2 months after enrollment, thereafter one dose (4 pills) fortnightly for next 2 months (3rd & 4th month) and subsequently one dose (4 pills) per month for last 20 months (5th – 24th month). |
| Comparator Agent |
Placebo |
One dose (4 pills) per week will be given to children for initial 2 months after enrollment, thereafter one dose (4 pills) fortnightly for next 2 months (3rd & 4th month) and subsequently one dose (4 pills) per month for last 20 months (5th – 24th month). |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary written informed consent by the parent/ guardian.
No diarrhoea at the time of enrolment to study
|
|
| ExclusionCriteria |
| Details |
Diarrhea during last 7 days.
Child taking any other Homeopathic medicines.
Child seeking treatment for any other diseases or life-threatening complications or suffering from any other immuno-compromised disease.
Parents refused to give written informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of diarrhoea |
Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of diarrhoeal episode |
Weekly |
| Hospitalization rates for diarrheal episode |
Weekly |
| Usage of conventional medication for diarrheal episode |
Weekly |
| Frequency of diarrheal episodes during study period. |
Weekly |
|
|
Target Sample Size
|
Total Sample Size="7000"
Sample Size from India="7000"
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)
|
15/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be a cluster randomised, double-blind, placebo controlled trial wherein apparently healthy children of age 1 - 10 years residing in slums of Holambi kalan of Delhi, shall be enrolled in the study. Health workers shall screen children who fulfill the inclusion criteria for the enrollment in the study. The children will be enrolled into 3 groups and shall receive medicine as per dosage pattern assigned.
- Group 1 - Approx. population of 2000 receiving Cuprum metallicum 30C
- Group 2 - Approx. population of 2000 receiving Camphor 30C
- Group 3 - Approx. population of 2000 receiving placebo
The dosage of medicine and placebo shall be one dose (4 pills) per week for initial 2 months after enrollment, thereafter one dose (4 pills) fortnightly for next 2 months (3rd & 4th month) and subsequently one dose (4 pills) per month for last 20 months (5th – 24th month). I.E.C material regarding prevention of diarrhoeal diseases shall be given to participants in all 03 groups. The participants will be observed weekly for medicine compliance and for incidences of diarrhea. Primary outcome measure will be comparison of incidence of diarrhea between the groups. |