Role of Herbal Immunomodulators in in Boosting the Immunity among healthcare workers assigned to COVID-19 wards

An Open Label, Prospective, Clinical Study to Evaluate The Role Of Herbal Immunomodulators (Tab Immusante and Tab Guduchi) in Boosting the Immunity among healthcare workers assigned to COVID-19 wards

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026579

Enrollment

100

Registered

2020-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tab. Immusante and Tab. Guduchi: Herbal Formulations (Tab. Immusante and Tab. Guduchi)- Each tablet is recommended at a dose of 1 tablet twice daily orally (BD) for 30 days Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or non-pregnant female subjects, aged 18-60 years old, 2.High risk people like Health care workers (Doctors, Nurse, Laboratory technicians, Other hospital support staff), community health care workers assigned to COVID-19 wards. 3. Female of child-bearing potential willing to follow reliable and strict contraceptive measures. 4. Subjects 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 willing to follow the regulations as per prevailing guidelines. 5. Willing to give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Current active/ Confirmed / relapsed COVID-19 positive cases 2. Pregnant or lactating women. 3. Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). 4. Unable to take oral medication or suffering from ailments related to absorption. 5. Suffering from Immunocompromising conditions or taking any immunosuppressing therapy. 6. Subjects suffering from severe and uncontrolled metabolic/endocrinal/cardiac/renal/liver disease. 7. The subject with known hypersensitivity to any of the test materials or related compounds. 8. The subject who are unable or unwilling to comply fully with the study protocol. 9. Physician makes a decision that trial involvement is not in subjectsâ?? best interest, or any condition that does not allow the protocol to be followed safely.

Design outcomes

Primary

Measure	Time frame
Incidence of subjects presenting with respiratory symptoms during study Improvement in the immune status based on the adapted Immune status Questionnaire (ISQ) Overall well-being (SF-12 Health Survey) Timepoint: Visit 1 Baseline Visit 2- Day 7Â±3day/ Telephonic optional Visit 3- Day 14Â±3day/ Telephonic optional Visit 4- Day 30Â±3day/EOS (Telephonic optional) Visit 5-Day 45Â±3day/ Follow-up visit (Telephonic optional) Either Visit 4 or Visit 5, one of the Visit should be Onsite Visit	—

Measure

Time frame

Incidence of subjects presenting with respiratory symptoms during study Improvement in the immune status based on the adapted Immune status Questionnaire (ISQ) Overall well-being (SF-12 Health Survey) Timepoint: Visit 1 Baseline Visit 2- Day 7Â±3day/ Telephonic optional Visit 3- Day 14Â±3day/ Telephonic optional Visit 4- Day 30Â±3day/EOS (Telephonic optional) Visit 5-Day 45Â±3day/ Follow-up visit (Telephonic optional) Either Visit 4 or Visit 5, one of the Visit should be Onsite Visit

—

Secondary

Measure	Time frame
Incidence of adverse effects Study Drug ComplianceTimepoint: Visit 1 Baseline Visit 2- Day 7Â±3day/ Telephonic optional Visit 3- Day 14Â±3day/ Telephonic optional Visit 4- Day 30Â±3day/EOS (Telephonic optional) Visit 5-Day 45Â±3day/ Follow-up visit (Telephonic optional) Either Visit 4 or Visit 5, one of the Visit should be Onsite Visit	—

Countries

India

Contacts

Public ContactDr Soorya Narayan H

The Himalaya Drug Company

dr.palani@himalayawellness.com

Outcome results