A clinical trial to evaluate safety and efficacy of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster in the suspected and COVID-19 diagnosed patients.

A Multi-centric, Double blind, Randomized, Comparative, Parallel-group, Placebo-controlled, Phase III clinical trial to evaluate the efficacy and safety of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster, anti-cough, expectorant, anti inflammatory, cardio-protective, hepato-protective, broncho-protective in the suspected and COVID-19 diagnosed patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025590

Enrollment

120

Registered

2020-06-03

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

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Astha-15 capsule: Two capsules to be taken orally twice a day. Two capsules after breakfast and two capsules after dinner with standard care of therapy Control Intervention1: Placebo: T

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures. 2. Non-ICU patients suspected and diagnosed of COVID-19 diseases (In hospital isolation / quarantine ward). 3. Subjects having stable common respiratory associated disorders like Flu & common cold, allergic rhinitis, asthma and COPD.

Exclusion criteria

Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form. 2. Subject with positive pregnancy test as confirmed by urine dipstick test and who is planning to become pregnant within the study duration/lactating mothers. 3. Patients having psychiatric, musculoskeletal or cardiovascular diseases. 4. Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, neurological disorders and diarrhoeal disorders. 5. Patients having a haemoglobin level 6. Patients having serious or unstable respiratory and its associated disorders. 7. Use of systemic corticosteroid therapy (this may affect peripheral muscle function). 8. Thyrotoxicosis, or diabetes treated with insulin. 9. Subjects having BMI less than 18.

Design outcomes

Primary

Measure	Time frame
1. Changes in scores of the St. George Respiratory Questionnaire from baseline to EOT visit. 2. Changes in scores of the Leicester Cough Questionnaire from baseline to EOT visit.Timepoint: Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)	—

Secondary

Measure	Time frame
1. Changes in scores of Quality of life Questionnaire from baseline to EOT visit. 2. Evaluation and comparison of subjects of both group not attaining ICU rather gaining potential to get recovered during the study treatment.Timepoint: Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)	—

Countries

India

Contacts

Public ContactMukesh Kumar

RAHE Life Science

mukesh@rahelife.com9873038019

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026