Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

Study Overview
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Brief Summary
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Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety, preventative and curative measures to control the spread of virus. Confirmed cases are treated with clinical management as they are diagnosed but so far, there is no effective treatment or vaccine yet for Covid-19. With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear. Present study examined the efficacy and safety of one of the recommended Ayurveda drug (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19 patients.

Official Title
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A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

Conditions
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Covid19, Asymptomatic Condition

Intervention / Treatment
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* Drug: Guduchi Ghan Vati


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 A person diagnosed with COVID-19 Asymptomatic at the time of admission Exclusion Criteria: Patients over 75 years Taking antibiotics or antiretroviral for any reason Mild to Moderate symptoms at the time of hospital admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ayurveda<br>Guduchi Ghan Vati was given to Covid patients 2 tablets (500 mg each) twice daily were given orally after meal for 28 days. Guduchi ghan vati is a powdered aqueous extract of Tinospora cordifolia in tablet form and prepared in GMP certified Pharmacy of the University, following standard protocol. | Drug: Guduchi Ghan Vati<br>* Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.<br>* Other names: Giloy Ghan Vati;|
| Control<br>Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic clearance | Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of patients going from asymptomatic to moderately disease | change in the number of patients going from asymptomatic to moderately disease | 10-days of hospital admission | 
| Hospital Stay | Total duration of stay in hospital for complete recovery | 21 days | 
| Clinically relevant adverse effects | Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported) | 21-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ayurveda, Guduchi Ghan Vati