Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection

Covid19 Clinical Trial

Official title:

Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542876
• Other study ID #: AYU/DSSR/03
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 18, 2020

Study information

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

Clinical Trial Summary

The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 18, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All hospitalised cases above 18 years of age,

• Diagnosed with Covid-19

• Asymptomatic at the time of admission

• Agree to give consent

Exclusion Criteria:

• Symptoms relating to Covid-19

• Severe vomiting

• Respiratory failure or requiring mechanical ventilation

• Patients having alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper range of normal limits

• Patients with Covid-19 in critical condition or ARDS or NIAD 8 -point ordinal score-2

• Patients with uncontrolled diabetes mellitus

• Malignant,

• Chronic renal failure or

• On immunosuppressive medication

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Drug:
• Guduchi Ghan Vati
Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Aarogyam UK	Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

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	14 days
Secondary	Hospital Stay	Total duration of stay in hospital for complete recovery	14 days
Secondary	Clinically relevant adverse effects	Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form	14 days
Secondary	Laboratory tests	Routine blood tests were performed to assess complete blood counts, blood biochemistry parameters {Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin} and immunoglobulines.	change from baseline to 14 days