Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

NCT04480398 | Completed DMC

• 1 other identifier: AYU/DSSR/02
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety, preventative and curative measures to control the spread of virus. Confirmed cases are treated with clinical management as they are diagnosed but so far, there is no effective treatment or vaccine yet for Covid-19. With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear. Present study examined the efficacy and safety of one of the recommended Ayurveda drug (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19 patients.

Conditions

Covid19; Asymptomatic Condition

Keywords

Ayurveda; Guduchi Ghan Vati

Outcome Measures

Primary Outcomes (1)

• Virologic clearance

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

  21 days

Secondary Outcomes (3)

• Change in the number of patients going from asymptomatic to moderately disease

  10-days of hospital admission

• Hospital Stay

  21 days

• Clinically relevant adverse effects

  21-days

Study Arms (2)

Ayurveda

Guduchi Ghan Vati was given to Covid patients 2 tablets (500 mg each) twice daily were given orally after meal for 28 days. Guduchi ghan vati is a powdered aqueous extract of Tinospora cordifolia in tablet form and prepared in GMP certified Pharmacy of the University, following standard protocol.

Drug: Guduchi Ghan Vati

Control

Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines.

Interventions

Guduchi Ghan Vati DRUG

Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.

Also known as: Giloy Ghan Vati

Ayurveda

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Covid-19 Confirmed Asymptomatic patients

You may qualify if:

• Age over 18
• A person diagnosed with COVID-19
• Asymptomatic at the time of admission

You may not qualify if:

• Patients over 75 years
• Taking antibiotics or antiretroviral for any reason
• Mild to Moderate symptoms at the time of hospital admission

Sponsors & Collaborators

• Aarogyam UK: lead
• Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University: collaborator
• Samta Ayurveda Prakoshtha, India: collaborator

Study Sites (1)

Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur, Rajasthan, India

Location

MeSH Terms

Conditions

COVID-19; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Parashar Sharma

  Samta Ayurveda Prakoshtha

  STUDY CHAIR

• Jaydeep Joshi

  Aarogyam UK

  STUDY CHAIR

• Neha Sharma

  Aarogyam UK

  STUDY DIRECTOR

• Abhimanyu Kumar

  Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 21, 2020
• Study Start: May 12, 2020
• Primary Completion: June 15, 2020
• Study Completion: July 3, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

IN (1)