Covid19NCT04480398
Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
An observational study of Covid19 and Asymptomatic Condition, run by Aarogyam UK at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Asymptomatic Condition
- What is being tested?
- Guduchi Ghan Vati
- Type of treatment
- Pill or oral medicine
- How many people
- 91 participants
- Where
- 1 siteIndia
- Study dates
- 12 May 2020to 3 Jul 2020
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Covid-19 Confirmed Asymptomatic patients
Who may be able to join
- Age over 18
- A person diagnosed with COVID-19
- Asymptomatic at the time of admission
Who cannot join
- Patients over 75 years
- Taking antibiotics or antiretroviral for any reason
- Mild to Moderate symptoms at the time of hospital admission
Trial locations and contacts
1 site in 1 country.
India1 site
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur, Rajasthan
About this study
Official title: A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
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
- Being tested
- Guduchi Ghan Vati
- Keywords
- Ayurveda, Guduchi Ghan Vati
- Medical subject headings
- COVID-19, Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guduchi Ghan VatiDrug
Also called Giloy Ghan Vati
Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Guduchi Ghan Vati | |
| Control | Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines. |
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: 21 days
Secondary outcomes (3)
Change in the number of patients going from asymptomatic to moderately disease
change in the number of patients going from asymptomatic to moderately disease
Measured: 10-days of hospital admission
Hospital Stay
Total duration of stay in hospital for complete recovery
Measured: 21 days
Clinically relevant adverse effects
Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)
Measured: 21-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start12 May 2020
- Primary completion15 Jun 2020
- Study completion3 Jul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India
- Responsible party
- Sponsor
- Investigators
- Parashar Sharma, Study chair, Samta Ayurveda PrakoshthaJaydeep Joshi, Study chair, Aarogyam UKNeha Sharma, Study director, Aarogyam UKAbhimanyu Kumar, Principal investigator, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480398
- Sponsor's protocol ID
- AYU/DSSR/02
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 22 Jul 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 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
- ClinicalTrials.gov ID
- NCT04480398
- Acronym / sponsor ID
- AYU/DSSR/02
- Conditions
- Covid19, Asymptomatic Condition
- Keywords
- Ayurveda, Guduchi Ghan Vati
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India
- Study start
- 12 May 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 21 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | – | Drug: Guduchi Ghan VatiGuduchi 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. |
| Control | – | –Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Covid-19 Confirmed Asymptomatic patients
Key inclusion criteria (3 listed)
- Age over 18
- A person diagnosed with COVID-19
- Asymptomatic at the time of admission
Key exclusion criteria (3 listed)
- Patients over 75 years
- Taking antibiotics or antiretroviral for any reason
- Mild to Moderate symptoms at the time of hospital admission
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: Giloy Ghan VatiGuduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia. | Drug | Ayurveda |
Primary outcome
Virologic clearance
Time frame: 21 days
Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
3 secondary outcomes
Change in the number of patients going from asymptomatic to moderately disease
Time frame: 10-days of hospital admission
Hospital Stay
Time frame: 21 days
Clinically relevant adverse effects
Time frame: 21-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 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Parashar Sharma study chair
Samta Ayurveda Prakoshtha
Jaydeep Joshi study chair
Aarogyam UK
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?
An observational study of Covid19 and Asymptomatic Condition, 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 3 inclusion and 3 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 22 Jul 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: 21 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 22 Jul 2020.