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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Guduchi Ghan Vati

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jodhpur, Rajasthan, India
      • Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ayurveda; Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.	Drug: Guduchi Ghan Vati; Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.; Other Names: Giloya; Amrita; Tinosporia Cordifolus; Guduchi

What is the study measuring?

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	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Stay	Total duration of stay in hospital for complete recovery	14 days
Clinically relevant adverse effects	Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form	14 days
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

Collaborators and Investigators

• Sponsor: Aarogyam UK
• Collaborators: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ACTUAL): July 31, 2020
• Study Completion (ACTUAL): August 18, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AYU/DSSR/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No