Clinical study to assess role of Vasa Ghana, Guduchi Ghana and Vasa-GuduchiGhana in therapeutic management of symptoms in Covid19

Phase 4

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

• Registration Number: CTRI/2020/09/028043
• Lead Sponsor: Ministry of AYUSH Govt of India

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

People who have been tested positive to be infected with SARS-CoV2 virus and

presenting with no symptoms or mild symptoms

Voluntariness to participate in the trial

Patients who are able to take the drug orally and comply with study procedures.

Women of childbearing potential must have a negative urine pregnancy test prior to

study entry.

Age 19-65 years

Exclusion Criteria

COVID patients with symptoms classified as moderate, severe or critical. Patients

suffering from severe COVID-19 disease as judged by a physician and fulfilling

at least two of the following three criteria:

Respiratory distress at room ambience (>=30 breaths per min)

SaO2/ SpO2 < 90% on room air and requiring oxygen support for more

than one hour to normalize.

PaO2/ FiO2 < 300 mmHg.

Any of the known COVID-19 complications and emergency procedures

which may require shift/admission in intensive care unit such as

respiratory failure, adult respiratory distress syndrome, requirement of

oxygen support for more than 1 hour, requirement of mechanical

ventilation, septic shock, or severe non-respiratory organ dysfunction or

failure. (Adapted and modified from the reference: Yang Liu et al. Lancet

Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2)

Individuals with uncontrolled, unstable co-morbidities/ co-existent medical illness

such as diabetes, hypertension, cardiac disorders, liver, kidney disorders and lung

disorders or other disease of concern that may put the patient at increased risk

during the study.

Persons with serious complications of 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.

Individuals with pre-existing respiratory conditions

Immuno-compromised individuals or those on immune suppressants. History of

immune suppression: solid organ or bone marrow transplant, use of immune

suppressive anti-metabolic and biologic agents, intrinsic immune deficiencies, HIV

infection.

Patients on or requiring parenteral nutrition

Patients with known sensitivity or contraindication to any of the study medication.

Pregnant and lactating females

Patients who are likely to worsen or planed ICU admission or ventilator support

due to any reason.

COVID-19 positive cases participating as subjects in the interventional arm of

other COVID-19 clinical trials.

Participation in a drug interventional clinical drug trial of any nature in the three

month period preceding onset of COVID-19.

Patients on any kind of Ayurveda treatment or any other alternative and

complementary medicinal systems such as Homeopathy, Unani, Siddha and in

particular requiring oral therapy of any kind.

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

Patient with persistent vomiting more than three episodes of vomiting in 12 hours,

preventing adequate oral hydration.

Patient with known active hepatitis, and definite bacterial or fungal infections.

Patient with altered mental state.

Patient taking concomitant medication associated with QTc-interval prolongation,

which cannot be withdrawn prior to study drug administration.

Patient with history of evidence of chronic interstitial infiltration at imaging.

Patient with history of serology tests positive for hepatitis B, hepatitis C, or human

immune deficiency virus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of time to clinical improvement/disease progression <br/ ><br>Duration of fever and respiratory symptoms <br/ ><br>Incidence of respiratory failure <br/ ><br>Number of days of treatment and hospitalization <br/ ><br>Requirement of SOS medication- reason and no.of times <br/ ><br>Requirement of Rescue medication <br/ ><br>Percent mortality <br/ ><br>Adverse events <br/ ><br>Percent mortality <br/ ><br>Changes in all the Lab parametersTimepoint: Length of time to clinical improvement/disease progression <br/ ><br>Duration of fever and respiratory symptoms <br/ ><br>Incidence of respiratory failure <br/ ><br>Number of days of treatment and hospitalization <br/ ><br>Requirement of SOS medication- reason and no.of times <br/ ><br>Requirement of Rescue medication <br/ ><br>Percent mortality <br/ ><br>Adverse events <br/ ><br>Percent mortality <br/ ><br>Changes in all the Lab parameters

Secondary Outcome Measures

Name	Time	Method
ength of time to clinical improvement/disease progression <br/ ><br>Duration of fever and respiratory symptoms <br/ ><br>Incidence of respiratory failure <br/ ><br>Number of days of treatment and hospitalization <br/ ><br>Requirement of SOS medication- reason and no.of times <br/ ><br>Requirement of Rescue medication <br/ ><br>Percent mortality <br/ ><br>Adverse events <br/ ><br>Percent mortality <br/ ><br>Changes in all the Lab parametersTimepoint: (days from admission; days from first testing <br/ ><br>positive; days from first noticed symptoms)