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临床试验/CTRI/2020/09/028007
CTRI/2020/09/028007尚未招募2 期

Ashwagandha for the Prophylaxis against SARS-COV-2 Infection: A Randomized Hydroxychloroquine Controlled Clinical Trial in Health Care Providers

CSIR Ministry of Ayush0 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
尚未招募
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

  • 1)Participants of either sex,20 to 69 years of age
  • 2)Participants tested negative COVID-19 by nose throat swab using PCR technique
  • 3)Participants should be naive for HCQ
  • 4)Willing to come for regular follow-up visits
  • 5)Written informed consent

排除标准

  • 1)Individuals with known hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency)
  • 2)Pregnant women, lactating women and women of child bearing potential. hypersensitivity orIntolerance to Hydroxychloroquine will not be assigned to HCQ intervention arms in Group A and Group B Contraindications to HCQ use such as psoriasis, porphyria, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • 3)Individuals with known allergy or contraindication to Ashwagandha
  • 4)Have any Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the participant at increased risk during the study
  • 5)History of having received any investigational drug in the preceding one month.
  • 6)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
  • 7)History of taking any kind of Ayurvedic formulation or any other form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months
  • 8)Unwilling to come for regular follow-up for the entire duration of the study.
  • 9)Non â?? co-operative attitude of the participant
  • 10)Any condition that, in the opinion of the investigator, does not justify the
  • participantâ??s inclusion in the study.

研究者

发起方
CSIR Ministry of Ayush

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