Homoeopathic medicine Belladonna 30 in preventing Heat Related Illness

Not yet recruiting

• Conditions: Heat related illness

• Registration Number: CTRI/2025/04/085489
• Lead Sponsor: Central Council for Research in Homoeopathy

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-22
• Study Start: 2025-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Voluntary written Informed consent by the family head.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Central Council for Research in Homoeopathy; 🇮🇳 West, DELHI, India

Central Council for Research in Homoeopathy

🇮🇳West, DELHI, India

Dr Debadatta Nayak

Principal investigator

9873040412

drdnayak@gmail.com