Ayurvedic Proprietary Medicine (VIRANORM) clinical trial on COVID-19 patients

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/09/028158
• Lead Sponsor: K Wellness

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Must be >=18 years and <=70 years at the time of signing the informed consent

2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures

3. Able to adhere to the study visit schedule and other protocol requirements

4. Asymptomatic or Mild Symptomatic PCR positive COVID-19 infection with outpatient/in-patient management as decided by the treating physician

5. Early warning score for 2019-nCoV infected patients < 5

6. Females of childbearing potential must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe

7. Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met

Exclusion Criteria

1. Requirement for oxygen administration

2. Shortness of breath in resting position

3. Creatinine > 2.0 mg/dl

4. Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).

5. Women during pregnancy and lactation

6. Participation in other clinical trials or observation period of competing trials

7. Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).

8. Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).

9. Physician decision that involvement in the study is not in the patient´s best interest

10. History of alcohol or drug abuse in the previous two years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified