| CTRI Number |
CTRI/2025/04/085489 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic medicine Belladonna 30 in preventing Heat Related Illness |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Intervention Belladonna 30 in Preventing Heat related illnesses: A Cluster randomized, Double-Blind, Parallel Arm, 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-IV |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Epidemic cell, Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri
New Delhi
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-IV |
| 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 |
9873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research officer (H)/ Scientist-IV |
| 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 |
9873404012 |
| 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 |
| 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 |
Belladonna 30 |
Children - 02 pills in each dose of Belladonna 30, to be given twice every week till the termination of heat wave as per IMD
Adults - 04 pills in each dose of Belladonna 30, to be given twice every week till the termination of heat wave as per IMD. |
| Comparator Agent |
Placebo |
Children - 02 pills in each dose of placebo, to be given twice every week till the termination of heat wave as per IMD
Adults - 04 pills in each dose of placebo, to be given twice every week till the termination of heat wave as per IMD. |
|
|
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 |
1) Pregnant or lactating females.
2) Child below age of 1 year.
3) Patients with malignancy, immune-compromised state, life threatening diseases,
end stage diseases
4) 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 symptoms of heat-elated illnesses (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 |
1st Week, 2nd Week, 3rd Week, 4th Week, 5th Week, 6th Week, 7th Week, 8th Week, 9th Week,
10th Week |
|
|
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="10000"
Sample Size from India="10000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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, parallel arm, placebo-controlled trial to assess the effectiveness of homeopathic medicine Belladonna 30 in preventing heat related illnesses. The population will be enrolled from 15 urban slum clusters of Delhi, where there is a significant chance of getting affected by heat and contracting symptoms of heat related illnesses. Study participants who will fulfilled the inclusion criteria and providing the written consent shall be enrolled in the study and randomized to either group as below:
Group I - H+GM Arm - Homoeopathic intervention Belladonna 30 along with IEC regarding general measures for prevention of heat-related illnesses. Group II- P+GM Arm - Placebo along with IEC regarding general measures for prevention of heat-related illnesses.
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 illnesses amongst the population of 15 clusters. |