跳至主要内容
临床试验/CTRI/2021/06/034433
CTRI/2021/06/034433已完成2 期

A Prospective, Randomized, Open Label, Two arm, Comparative Clinical Study to Evaluate the effect of IMMUNODAATââ??¢ Botanical Ingredient, in Post Covid-19 recovery - NI

ODAAT PHARMA0 个研究点目标入组 74 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
74

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.Patients who had mild to moderate symptoms [as per US-CDC classification) of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html) (Mild symptoms up to mild pneumonia) and is recovered clinically.
  • 2.Patients will be recruited from the day of clinical recovery till next 15 days and having Post Covid Symptoms as per https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects
  • 3.Ready to provide written informed consent for participation in the study
  • 4.Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt. / local health authority throughout the study period.

排除标准

  • 1.Subjects who had severe COVID-19 (moderate to severe pneumonia)
  • 2.Subjects with post COVID 19 complications (those who had gone into severe type of COVID-19)
  • 3.Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
  • 4.Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
  • 5.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
  • 6.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
  • 7.Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study
  • 8.Allergies, known to be allergic to IMMUNODAATââ??¢ Botanical Ingredient
  • 9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results

研究者

发起方
ODAAT PHARMA

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