CTRI/2010/091/001442招募中2 期
Preparation and assessment of topical preparation(s) enhancing peripheral microcirculation using nuclear medicine technology in civilian volunteers, followed by limited field experience at high altitude for preventing or treating various degrees of cold-injury
Defence R&D Organisation0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy volunteers
- •1. Healthy Males/females, between 18-65 years ages group
- •2. On no permanent treatment
- •3. Suffering from no permanent / recurrent / chronic disease or disability
- •Diseased subjects
- •a) Mild cold injury
- •1. Painful cold periphery (hands & feet) attributed to cold injury in appropriate weather conditions.
- •2. Age group: 18-65 years
- •3. Ambulatory, preferably confined patients for better follow-up
- •4. Assured availability for 7-10 days
- •5. Non-critically ill patients.
- •6. Educated persons capable of self assessment (quantitative)
- •b) Significant cold injury
- •1. Age group: 18-65 years
- •2. One or more frostbite lesions (superficial / deep)
- •3. Ambulatory, preferably confined patients for better follow-up
- •4. Assured availability for 7-10 days
- •5. Non-critically ill patients
- •6. Educated persons capable of self assessment (quantitative)
排除标准
- •Healthy volunteers
- •1. Those who do not sign the ICF
- •2. Those who refuse to abide by the rules/briefing
- •3. Those who have had any medical condition which in the judgment of the investigator may render them inappropriate for participation in the trial.
- •4. Patients who have received any other investigational drug for the last 1 month.
- •5. Too low or too high body weight (< 40 kg, > 100 kg).
- •Diseased subjects
- •1. Patients with prior hypersensitivity to salbutamol
- •2. Patients who are unwilling to give informed consent.
- •3. Patients receiving beta-agonists within 1 week of the start of the study with persisting medical effect.
- •4. Patients with very large lesions, extensively broken / ulcerated skin
- •5. Volunteers with serious or critical illness.
- •6. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception (except those with severe disease and who are likely to be benefit in the clinical judgment of clinician in charge).
- •7. Patients with skin disease in the area of cold injury / other lesions.
- •8. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders.
- •9. Patients who have any medical condition which in the judgment of the investigator may render them inappropriate for participation in the trial.
- •10. Patients who have received any other investigational drug for the last 1 month
研究者
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