| CTRI Number |
CTRI/2024/06/068756 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in Preventing Heat related illnesses |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Intervention Glonoine 30 in Preventing Heat Related illness: A Cluster-randomized, Double Blind, Parallel Arm, Placebo-Controlled Trial |
| 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 Debadatta Nayak |
| Designation |
Research Officer/ Scientist-III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/ Scientist-III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri
DELHI
110058
India |
| Phone |
01128525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/ Scientist-III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri
DELHI
110058
India |
| Phone |
01128525388 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65, Institutional Area, Opp. D-Block, Janakpuri, Delhi 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy, New Delhi, 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 303, 61-65, Institutional area, Opposite D block, Janakpuri
South West
DELHI |
9873040412
drdnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Heat related illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glonoine 30 |
02 pills in each dose of the Glonoine 30 given every third day till the termination of heat wave as per IMD to children. 04 pills in each dose of Glonoine 30 given every third day till the termination of heat wave as per IMD to adults. |
| Comparator Agent |
Placebo |
02 pills in each dose of the placebo given every third day till the termination of heat wave as per IMD to children. 04 pills in each dose of placebo given every third day till the termination of heat wave as per IMD to adults. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Voluntary written Informed consent by the family head. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating females.
Child below age of 1 year.
Patients with malignancy, immune-compromised state, life threatening diseases, end stage diseases
Patient with symptoms of acute infectious illnesses at the time of enrolment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness induced due to exposure of heatwave |
Daily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intensity of symptoms (headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness) induced due to exposure of heatwave |
Daily |
| Mean duration of symptoms (headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness) induced due to exposure of heatwave |
Daily |
| Proportion of cases of heat related illnesses requiring hospitalization |
At the time of analysis |
|
|
Target Sample Size
|
Total Sample Size="25000"
Sample Size from India="25000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a prospective, randomized, double blind, placebo controlled trial to assess the effectiveness of homoeopathic medicine Glonoine 30 for prevention of Heat related illness. The study is a field study wherein apparently healthy participants will be enrolled from the population residing in 05 urban slums of Delhi, where there is significant chance of getting affected by heat related illness. Study participants who fulfil the inclusion criteria and willing to provide informed written consent shall be enrolled in the study and randomized to either group as below:
Group I - H+GM’ Arm - Homoeopathic intervention Glonoine 30 along with IEC regarding general measures for prevention of heat related illnesses will be provided to 03 clusters. Group II - ‘P+GM’ Arm - Placebo along with IEC regarding general measures for prevention of heat related illnesses will be provided to 02 clusters.
The study will be carried out till the termination of heat wave as per Indian Meteorological Department. The primary outcome shall be incidence of heat related illness amongst population of 05 slums. |