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

Completed

• Conditions: Covid19; Asymptomatic Condition
• Interventions: Drug: Guduchi Ghan Vati

• Registration Number: NCT04480398
• Lead Sponsor: Aarogyam UK

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Primary Completion: 2020-06-15
• Status Verified: 2020-07
• Study Completion: 2020-07-03
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-21
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ayurveda	Guduchi Ghan Vati	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.

Primary Outcome Measures

Name	Time	Method
Virologic clearance	21 days	Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University; 🇮🇳 Jodhpur, Rajasthan, India