跳至主要内容
临床试验/CTRI/2020/08/027163
CTRI/2020/08/027163进行中(未招募)2 期

A Study of Ashwagandha in the Prophylaxis Against COVID-19 and its Benefits on General Health in High Risk Health Care Workers: A Randomized Controlled Comparison with Hydroxychloroquine Sulphate (HCQS)

Ministry Of AYUSH CCRAS0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方

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

  • I.Participants of either sex, 20-65 years of age
  • II.Participants testing negative for SARS-CoV-2 by RT PCR technique using nose and throat swab
  • III.Participants testing negative for anti-SARS-CoV-2 IgG antibodies
  • IV.HCQS naïve participants
  • V.Willing to come for regular follow up visits
  • VI.Written Informed Consent

排除标准

  • I.Participants with hypersensitivity or intolerance and contraindications(psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) to study drug use
  • II.Pregnant women, lactating women and women of child bearing potential not willing to follow adequate contraception
  • III.History of having received any investigational drug in the preceding one month
  • IV.History of regular intake of Ayurvedic or any other form of CAM (Complementary Alternative Medicine) formulation in the preceding 1 month
  • V.Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders, Retinopathy or other disease of concern which may put the participant at increased risk during the study
  • VI.Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other anti- hitaminic drugs, liquorice and potassium lowering drugs
  • VII.Serum Liver Enzymes >1.5 times of upper normal limits, Serum creatinine >2 mg/dL, Blood Urea >70 mg/dL, Blood Hemoglobin <9 gm/dL
  • VIII.Non co-operative attitude of the patient
  • IX.Any condition or circumstances which in the opinion of the investigator may make a participant unlikely or unable to complete the study or comply with study procedures and requirements

研究者

发起方
Ministry Of AYUSH CCRAS

相似试验