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

Phase 3

Recruiting

Conditions: Healthy Human Volunteers in high risk for having COVID-19 infected.

Brief Summary: It is well known that COVID-19 infection influences immunosuppressive people more harshly. Thusly, improving insusceptibility is unquestionably one of the manners in which the specialists over the globe have been utilizing for treating COVID-19 cases. Truth be told, high portions of vitamin C, known to support immunity, have been regulated to the COVID-19 patients in China and other countries with promising outcomes. Indian Council of Medical Research (ICMR) also endorsed the utilization of hydroxyl-chloroquinone for prophylactic treatment of COVID-19 positive cases as of late on March 26, 2020.

Ayurveda makes reference to various resistances boosting therapeutics, one of the incredibly Indian customary medications. The study objectives are the scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic.

Recruitment & Eligibility

Inclusion Criteria

Male or female > 18 and < 75 years of age (inclusive).
The normal healthy individuals.
High risk individuals.
Immunosuppressant peoples and subjects with mild to moderate co-morbidities.
Non-symptomatic subjects under Institutional and Home Quarantine.
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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Locations (11): Institutional Quarantine/ COVID Care Centre Almora
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Almora, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Chamoli
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Chamoli, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Champawat
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Champawat, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Dehradun
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Dehradun, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Garhwal
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Garhwal, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Haridwar
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Hardwar, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Nainital
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Nainital, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Pithoragarh
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Pithoragarh, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Rudraprayag
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Rudraprayag, UTTARANCHAL, India
Institutional Quarantine/ COVID Care Centre Tehri
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Garhwal, UTTARANCHAL, India
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Institutional Quarantine/ COVID Care Centre Almora
🇮🇳Almora, UTTARANCHAL, India
Dr Sandeep Kumar
Principal investigator
9456781360
sandeepguptamp@gmail.com