Role of Herbal Immunomodulators in mild COVID-19 confirmed cases

Phase 2

Completed

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

• Registration Number: CTRI/2020/06/025801
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for Low Clinical Risk (News Scoring 0-4)

2. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive within 7 days from symptom onset or Patients within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR).

3.Female of childbearing potential willing to follow reliable and strict contraceptive measures.

4.Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and compliance to quarantine procedure (as per prevailing guidelines).

5. Able to give written inform consent to participate in the study.

Exclusion Criteria

1.Confirmed COVID-19 positive cases with NEWS scoring system >=5.

2.Individual with acute respiratory distress presenting with RR > 24/mt, SaO2/SPO2<=94% in room air condition, or the Pa02/Fi02 ratio <300mgHg.

3.Pregnant or breastfeeding females.

4.Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD).

5.Unable to take oral medication or suffering from ailments related to absorption.

6.Suffering from Immunocompromising conditions or taking any immunosuppressing therapy.

7.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease.

8.The subject with known hypersensitivity to any of the test materials or related compounds.

9.The subject who are unable or unwilling to comply fully with the study protocol.

10.Physician makes a decision that trial involvement is not in patients best interest, or any condition that does not allow the protocol to be followed safely.

Study & Design

• Study Type: Interventional
• Study Design: Not specified