Covid19NCT04542876
Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection
A study testing Guduchi Ghan Vati in people with Covid19, run by Aarogyam UK at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Guduchi Ghan Vati
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2020to 18 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hospitalised cases above 18 years of age,
- Diagnosed with Covid-19
- Asymptomatic at the time of admission
- Agree to give consent
Who cannot join
- 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
Show all 9Show fewer
- Malignant,
- Chronic renal failure or
- On immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
India1 site
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur, Rajasthan
About this study
Official title: Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study
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
- Conditions
- Covid19
- Being tested
- Guduchi Ghan Vati
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guduchi Ghan VatiDrug
Also called Giloya, Amrita, Tinosporia Cordifolus, Guduchi
Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem. Receives: Drug: Guduchi Ghan Vati |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic clearance
Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
Measured: 14 days
Secondary outcomes (3)
Hospital Stay
Total duration of stay in hospital for complete recovery
Measured: 14 days
Clinically relevant adverse effects
Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form
Measured: 14 days
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.
Measured: change from baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 May 2020
- Primary completion31 Jul 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Responsible party
- Sponsor
- Investigators
- Abhimanyu Kumar, Principal investigator, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved UniversityNeha Sharma, Study director, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542876
- Sponsor's protocol ID
- AYU/DSSR/03
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study
- ClinicalTrials.gov ID
- NCT04542876
- Acronym / sponsor ID
- AYU/DSSR/03
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | Experimental | Drug: Guduchi Ghan VatiGuduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All hospitalised cases above 18 years of age,
- Diagnosed with Covid-19
- Asymptomatic at the time of admission
- Agree to give consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guduchi Ghan VatiAlso: Giloya, Amrita, Tinosporia Cordifolus, GuduchiGuduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks. | Drug | Ayurveda |
Primary outcome
Virologic clearance
Time frame: 14 days
Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
3 secondary outcomes
Hospital Stay
Time frame: 14 days
Clinically relevant adverse effects
Time frame: 14 days
Laboratory tests
Time frame: change from baseline to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhimanyu Kumar principal investigator
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Neha Sharma study director
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guduchi Ghan Vati in people with Covid19, run by Aarogyam UK at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic clearance (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.