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Clinical Trials/CTRI/2020/07/026462
CTRI/2020/07/026462
Completed
Phase 3

A prospective, interventional, case control study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of the disease in hospitalized SARS-CoV2 tested positive asymptomatic /mild to moderate symptomatic COVID-19 cases, managed as per Govt of India COVID-19 management guidelines, at a COVID-19 management facility

Central Council for Research in Unani Medicine CCRUM New Delhi0 sites62 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Enrollment
62
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
September 12, 2020
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients of either sex aged between 18\-65 years
  • 2\. Patients who have been tested positive with SARS\-CoV2 virus
  • Asymptomatic Patients
  • Patients with mild symptoms
  • Patients with moderate symptoms with respiratory rate \< 30 per minute and oxygen
  • saturation \> 90%
  • 3\. Voluntariness to participate in the trial
  • USCDC classification mild to moderate, severe and critical stages of COVID\-19
  • Stage Features
  • Asymptomatic No specific clinical symptoms of COVID\-19 disease

Exclusion Criteria

  • The subject must be excluded from participating in the trial if they fulfill anyone of the criteria as
  • mentioned below:
  • 1\. COVID\-19 patients with symptoms classified as severe or critical.
  • 2\. Suspected COVID\-19, not tested positive for COVID\-19 by RT\-PCR
  • 3\. Persons with severe primary respiratory disease or pneumonia
  • 4\. Pregnant and lactating women
  • 5\. Persons with serious diseases such as Cancer, Heart Disease, Stroke, Disabilities, Mental
  • illnesses, etc., and who are considered to be excluded from the study as evaluated by the
  • investigators
  • 6\. COVID\-19 positive cases participating as subjects in the interventional arm of other

Outcomes

Primary Outcomes

Not specified

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