CTRI/2023/03/051028尚未招募Phase 3 4
Efficacy of Ayurveda Nutritional Supplements and Yoga Protocol in the Preventing/Reducing of the Severity of Acute Mountain Sickness: An Open-Label RCT.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 1,660
- 试验地点
- 2
- 主要终点
- Primary:
研究概览
简要总结
Based on the available empirical and scientific evidence, the proposed clinical study has been planned to evaluate the efficacy of Ayurveda supplements along with yoga protocol in reducing the incidence of acute mountain sickness and thromboembolic events and to combat the stress related to high altitude and cold climatic conditions in Defence personnel deployed at high altitude areas.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Apparently healthy Indian Army volunteers aged 18-50 years irrespective of gender
- •Indian Army volunteers who will be found fit for deployment to high altitude areas (under the Ladakh region of the Northern Command of Indian Army)as per the existing guidelines
- •Indian Army volunteers who will be either deployed to high altitude area for the first time or resumed their deployment after break
- •Willing to participate and provide written informed consent.
排除标准
- •History of underlying cardiovascular disease or a clinically significant ECG abnormality, cerebrovascular disease, pulmonary disease, neurological disease, psychiatric illness, major venous thromboembolism (deep vein thrombosis/pulmonary embolism/cerebrovascular thrombosis), sickle-cell disease, metabolic diseases, malignancy, glaucoma etc.
- •Previous history of pulmonary edema or severe physiological response to high altitude such as high altitude pulmonary edema
- •History of uncontrolled DM (HbA1C > 8.0) and uncontrolled hypertension (> 140/90 mm Hg) even after medications
- •BMI ≥ 30 kg/m2
- •History of abnormal hepatic function (AST and/or ALT, > 2 times upper normal limit) or abnormal renal function (serum creatinine 1.2 mg%)
- •Subjects on any concomitant conventional medication on regular basis
- •History of surgery within six months prior to screening
- •History of blood transfusion or any blood products within 90 days prior to screening
- •History of chain smoking, alcohol use disorder and substance abuse
- •Any other condition which the P.I. thinks may jeopardize the safety of the subjects.
结局指标
主要结局
Primary:
时间窗: Baseline to first seven days, then on the first four days at each altitude.
•Incidence of AMS assessed through Lake Louise Scoring System (2018)
时间窗: Baseline to first seven days, then on the first four days at each altitude.
•Proportion of participants with LLSS score ≥ 6.
时间窗: Baseline to first seven days, then on the first four days at each altitude.
次要结局
- 1. Proportion of participants with thromboembolic events (DVT, PE, CVT, MI etc.) (DVT will be assessed through hand held vascular Doppler and other thromboembolic disorders will be assessed clinically and through relevant investigations)(2. Proportion of participants with normal markers of coagulation and hemostasis activation)
研究者
研究点 (2)
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