Efficacy and Safety of Guduchi Ghan Vati in the Managemen... | NCT04542876

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

NCT04542876

Sponsor

Aarogyam UK

Status

Completed

Last Update Posted

Sep 9, 2020Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Covid19

Interventions

Guduchi Ghan Vati

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Aug 18, 2020Actual

First Submitted Date

Sep 8, 2020

First Submission Date that Met QC Criteria

Sep 8, 2020

First Posted Date

Sep 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2020

Last Update Posted Date

Sep 9, 2020Actual

Name	Class
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ayurveda	Experimental	Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.	Drug: Guduchi Ghan Vati

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guduchi Ghan Vati	Drug	Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.	Ayurveda

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abhimanyu Kumar	Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University	Principal Investigator
Neha Sharma	Aarogyam UK	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University		Jodhpur	Rajasthan		India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515274	Amrita Bindu
C000722787	guduchi

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided