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临床试验/CTRI/2010/091/001388
CTRI/2010/091/001388招募中2 期

Multi center comparative phase-2 clinical trial to assess the efficacy and safety of L-arginine inhalation in treatment of secondary pulmonary hypertension & associated diseases

Defence R&D Organisation0 个研究点目标入组 113 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
招募中
发起方
入组人数
113
研究概览入排标准研究者记录与标识符相似试验

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

  • •a) Healthy volunteers
  • •1. Healthy Males/females, between 18-45 years ages group
  • •2. On no permanent treatment
  • •3. Suffering from no permanent / recurrent / chronic disease or disability
  • •b) Diseased subjects
  • •1. Worked up adult patients with pulmonary hypertension with associated mild or moderate asthma or COPD or ILD or with hypoxemia at high altitude
  • •2. Age group: 18-65 years
  • •3. Ambulatory, preferably admitted patients for better follow up
  • •4. Non-critically ill patients.

排除标准

  • •a) 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 judgement 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).
  • •b) Diseased subjects
  • •1. Patients with prior hypersensitivity to arginine
  • •2. Patients who are unwilling to give informed consent.
  • •3. Patients receiving oral or systemic arginine or other nitric acid donors or known to have increased indigenous nitric oxide production within 4 weeks of the start of the study.
  • •4. Patients with history of attack of ?Status Asthmaticus? within 6 months prior to enrollment or having severe dyspnoea.
  • •5. Patients on continuous oxygen
  • •6. Volunteers with serious or critical illness.
  • •7. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception.
  • •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. Athletes on unknown nutraceutials.
  • •10. Patients who have any medical condition which in the judgement of the investigator may render them in appropriate for participation in the trial.
  • •11. Patients who have received any other investigational drug for the last 1 month.

研究者

发起方
Defence R&amp;D Organisation

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