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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480398
• Other study ID #: AYU/DSSR/02
• Status: Completed
• Start date: May 12, 2020
• Est. completion date: July 3, 2020

Study information

• Verified date: July 2020
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 3, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases
• Covid19

Intervention

Drug:
• Guduchi Ghan Vati
Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.

Locations

Country	Name	City	State
India	Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University	Jodhpur	Rajasthan

Sponsors (3)

Lead Sponsor	Collaborator
Aarogyam UK	Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic clearance	Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result	21 days
Secondary	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
Secondary	Hospital Stay	Total duration of stay in hospital for complete recovery	21 days
Secondary	Clinically relevant adverse effects	Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)	21-days