drugset / Trial / NCT07436104

Mortality Control Program for Economically Productive Age Group in Tribal Area of Melghat.

NCT07436104

RandomizedParallel-groupTriple-blindTreatment

Summary

Background: Age specific mortality rate (ASMR) of 16-60 years is very high in Indian tribal areas due to communicable and non-communicable diseases. Objectives: The primary objective is to reduce the ASMR in 16-60 years age group by at-least 30% from 16 tribal villages of Melghat. The secondary objectives are to reduce cause-specific mortality rates (CSMR) in 16-60 years age group because of diarrhoea, malaria, pneumonia, etc. Design: Community-based, single-centered, parallel-arm, cluster randomised controlled trial. Setting: 36 tribal villages/clusters (research phase: 2004-2015) and 44 new villages (replication phase: 2016-2022) were externally randomized by lottery method to intervention arm (IA) or control arm (CA). Participants: All persons in age group of 16-60 years from inaccessible 80 tribal villages. Interventions: Trained VHWs in IA, provided behaviour change communication, treatment and referral. Except principal investigator, other study staff and participants were double blinded.

Timeline

Start
2004-01-01
Primary completion
2015-12-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg
Subject Azithromycin Small molecule
Subject Chloroquine Small molecule
Subject Norfloxacin Small molecule
Subject ORS Unknown
Subject Salbutamol Unknown