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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Guduchi Ghan Vati
Sponsored by
Aarogyam UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ayurveda

Arm Description

Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.

Outcomes

Primary Outcome Measures

Virologic clearance
Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result

Secondary Outcome Measures

Hospital Stay
Total duration of stay in hospital for complete recovery
Clinically relevant adverse effects
Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form
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.

Full Information

First Posted
September 8, 2020
Last Updated
September 8, 2020
Sponsor
Aarogyam UK
Collaborators
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
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1. Study Identification

Unique Protocol Identification Number
NCT04542876
Brief Title
Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection
Official Title
Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
Collaborators
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ayurveda
Arm Type
Experimental
Arm Description
Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.
Intervention Type
Drug
Intervention Name(s)
Guduchi Ghan Vati
Other Intervention Name(s)
Giloya, Amrita, Tinosporia Cordifolus, Guduchi
Intervention Description
Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.
Primary Outcome Measure Information:
Title
Virologic clearance
Description
Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Hospital Stay
Description
Total duration of stay in hospital for complete recovery
Time Frame
14 days
Title
Clinically relevant adverse effects
Description
Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form
Time Frame
14 days
Title
Laboratory tests
Description
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.
Time Frame
change from baseline to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Kumar
Organizational Affiliation
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Aarogyam UK
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
City
Jodhpur
State/Province
Rajasthan
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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