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临床试验/CTRI/2017/01/007704
CTRI/2017/01/007704已完成不适用

Field trial of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharshtra

Society for Education Action and Research in Community Health1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,000
试验地点
1
主要终点
Reduction in the prevalence of scabies in the intervention villages as compared to the control villages at the end community-based intervention

研究概览

简要总结

This study is a cluster randomized, parallel group, two arm controlled trial to assess the effectiveness of community-based intervention to control scabies in the tribal communities of Gadchiroli, Maharashtra. The study will be conducted in the selected 12 villages of Dhanora block of Gadchiroli district.  The community-based intervention package will target all people of the intervention villages. During community survey if the prevalence of scabies  is found to be less than 10%, then the intervention will include i) Treatment of cases of scabies with two doses of ivermectin  (200 microgram per kg) with a gap of 14 days, along with single dose ivermectin (200 microgram per kg) administration to household members unless contraindicated (weight less than 15 kg, pregnant and breastfeeding women, individual with neurologic disease such as parkinson’s disease or cerebral palsy and individual taking medication that is metabolised by the cytochrome p450 pathway eg. warfarin, anticonvulsants). ii) Ivermectin will be replaced by topical permethrin 5% lotion in the above “ivermectin contra-indication†groups. iii) In addition to scabies treatment, the identified infected scabies or impetigo cases will be treated with 0.5% gentian violet paint by health workers. The severe infected scabies and impetigo cases (fever above 101 0F, toxic and delirious, severe protein energy malnutrition children with infected scabies or impetigo, patients with more than 40 lesions, no response to health worker treatment) will be referred to the tribal friendly hospital of SEARCH for further management. iv) If the prevalence of scabies is more than 10% in the community, then all the villagers in place of household members of scabies patient in the intervention villages will be treated with a single dose of Ivermectin (200 microgram per kg) unless contraindicated. The primary outcome will be reduction of prevalence of scabies among people of intervention villages as compared to the control villages at the end of 2 months of community-based intervention. The secondary outcome will be reduction of prevalence of impetigo among people of intervention villages as compared to the control villages after 2 months of community-based intervention. Other secondary outcomes will be reduction of prevalence of scabies and impetigo among people of intervention villages as compared to the control villages after 12 months of community-based intervention.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
1.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria: Cluster/Village level: 1) Tribal village in the field practice area of SEARCH in Gadchiroli district of Maharashtra state of India 2) The village should provide community consent through Gram Sabha for participation in the study.
  • Individual: 1) Should provide verbal consent for participation in the study.

排除标准

  • Exclusion Criteria: Cluster level: 1) Village with population less than 100 Individual level: 1) Currently on, or has taken ivermectin in the previous 7 days 2) Has had topical 5% permethrin applied within previous 7 days 3) Seriously ill patients 4) Allergy to any of the components of the allocated drug regimen.

结局指标

主要结局

Reduction in the prevalence of scabies in the intervention villages as compared to the control villages at the end community-based intervention

时间窗: 2 months

次要结局

  • Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages at the end community-based intervention(2 months)
  • Reduction in the prevalence of scabies in the intervention villages as compared to the control villages after community-based intervention(12 months)
  • Reduction in the prevalence of impetigo in the intervention villages as compared to the control villages after community-based intervention(12 months)

研究者

申办方类型
Other [Non-Governmental Organisation]

研究点 (1)

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