Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level study

Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level, multi centric, non-randomized, comparative, interventional community based study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025861

Enrollment

500

Registered

2020-06-14

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: AYUSH INTERVENSION - Treatment Protocol - I:: Ayush Raksha Kwath 10 gms (A.P.I.) Luke warm decoction of of kwath churna twice daily 30 minute before breakfast and dinner Ashwagandha

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female > 18 and 2. The normal healthy individuals. 3. High risk individuals. 4. Immunosuppressant peoples and subjects with mild to moderate co-morbidities. 5. Non-symptomatic subjects under Institutional and Home Quarantine. 6. Symptomatic subjects under Institutional Quarantine. (Optional, subject to approval from concerned officials and departments) 7. Confirmed COVID-19 cases under isolation and treatment (Optional, subject to approval from concerned officials and departments) 8. Signed ICF

Exclusion criteria

Exclusion criteria: 1. Subjects 75 years of age 2. Uncontrolled systemic illness. 3. Hypersensitivity to any component of Investigational Drug. 4. Recent history of drug or alcohol abuse. 5. Pregnant female. 6. Pre-existing GI symptoms like nausea and vomiting. 7. Patients not willing to sign ICF. 8. Individuals with severe co-morbidities.

Design outcomes

Primary

Measure	Time frame
i. Clinical, psychological and Quality of life assessment ii. Comparative analysis of occurrence of COVID-19 in subjects taking Ayurvedic Interventions and those not taking Ayurvedic Intervention iii. Comparative analysis of occurrence of conclusive symptoms of COVID-19 (as per ordinal scale of clinical improvement published by WHO). iv. Comparative analysis of occurrence of conclusive symptoms of other than non-COVID-19Timepoint: From baseline assessment, 1 week, 2 week and 4 week	—

Measure

Time frame

i. Clinical, psychological and Quality of life assessment ii. Comparative analysis of occurrence of COVID-19 in subjects taking Ayurvedic Interventions and those not taking Ayurvedic Intervention iii. Comparative analysis of occurrence of conclusive symptoms of COVID-19 (as per ordinal scale of clinical improvement published by WHO). iv. Comparative analysis of occurrence of conclusive symptoms of other than non-COVID-19Timepoint: From baseline assessment, 1 week, 2 week and 4 week

—

Secondary

Measure	Time frame
Assesment of laboratory parameters Rapid ELISA COVID 19, PCR COVID 19, Viral Load, T.L.C. D.L.C; Hb% ; E.S.R. ; P.P.B.S., URINE : RE / ME etc. Incidence of COVID 19 infection in during study period in study population Requirement of treatment for symptoms developed, if any during trial periodTimepoint: From screening assessment till the end of two weeks	—

Countries

India

Contacts

Public ContactDr Alok Kumar Shukla

Department of Ayurvedic and Unani Services Uttarakhand

kkpandey.dr@gmail.com9634465557

Outcome results