跳至主要内容
临床试验/CTRI/2022/09/045922
CTRI/2022/09/045922尚未招募2 期

Strategies for rapid acclimatization to high altitude – using different modalities

DEFENCE RESEARCH AND DEVELOPMENTAL ORGANIZATION2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
Incidence of Acute Mountain Sickness

研究概览

简要总结

Exposure at high altitude (HA) induced hypobaric hypoxia is known to deteriorate health and decrease performance. The aim of the study is to develop of Rapid Acclimatization Schedule for HighAltitude in Western sector using different modalities. 400 volunteers within the age range of 20-40 years will be recruited. The volunteers will be randomized into 4 different groups - Control, Drug treated (Acetazolamide), Stay at Moderate Altitude (Short duration) and Intermittent Hypoxia Exposure (IHE). After recording their baseline parameters at Sea Level area they will be inducted to Stage - I HA by air followed by Stage - II HA by road. In all stages differentphysiological, physical and biochemical parameters would be assessed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Male

入选标准

  • a) Age group: 20 – 40 years b) Medical history: SHAPE – I.

排除标准

  • a) Smokers b) Drinker c) Prior induction to HA d) Medical history of any sort.

结局指标

主要结局

Incidence of Acute Mountain Sickness

时间窗: During the initial days after ascent to high altitude area.

次要结局

  • Exercise Capacity at High Altitude(After 48 and 72 hours after reaching high altitude area.)

研究者

发起方
DEFENCE RESEARCH AND DEVELOPMENTAL ORGANIZATION
申办方类型
Government funding agency

研究点 (2)

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