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

NCT ID: NCT04542876

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-08-18

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ayurveda

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

Group Type EXPERIMENTAL

Guduchi Ghan Vati

Intervention Type DRUG

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

Interventions

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Guduchi Ghan Vati

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

Intervention Type DRUG

Other Intervention Names

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Giloya Amrita Tinosporia Cordifolus Guduchi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

OTHER

Sponsor Role collaborator

Aarogyam UK

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abhimanyu Kumar

Role: PRINCIPAL_INVESTIGATOR

Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Neha Sharma

Role: STUDY_DIRECTOR

Aarogyam UK

Locations

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Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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AYU/DSSR/03

Identifier Type: -

Identifier Source: org_study_id

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