Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection
1 other identifier
interventional
46
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started May 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedSeptember 9, 2020
September 1, 2020
3 months
September 8, 2020
September 8, 2020
Conditions
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
14 days
Secondary Outcomes (3)
Hospital Stay
14 days
Clinically relevant adverse effects
14 days
Laboratory tests
change from baseline to 14 days
Study Arms (1)
Ayurveda
EXPERIMENTALGuduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.
Interventions
Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.
Eligibility Criteria
You may qualify if:
- All hospitalised cases above 18 years of age,
- Diagnosed with Covid-19
- Asymptomatic at the time of admission
- Agree to give consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur, Rajasthan, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abhimanyu Kumar
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- STUDY DIRECTOR
Neha Sharma
Aarogyam UK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 9, 2020
Study Start
May 1, 2020
Primary Completion
July 31, 2020
Study Completion
August 18, 2020
Last Updated
September 9, 2020
Record last verified: 2020-09