Efficacy of Homoeopathic Intervention Glonoine 30 in Preventing Heat Related illness: A Cluster-randomized, Double Blind, Parallel Arm, Placebo-Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 25,000
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Voluntary written Informed consent by the family head.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: Daily
Secondary Outcomes
- 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)
Investigators
Dr Debadatta Nayak
Central Council for Research in Homoeopathy