CTRI

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CTRI Number

CTRI/2020/09/028043 [Registered on: 24/09/2020] Trial Registered Prospectively

Last Modified On:

24/09/2020

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Clinical study to assess role of Vasa Ghana, Guduchi Ghana and Vasa-Guduchi Ghana in therapeutic management of symptoms in Covid19

Scientific Title of Study

A Prospective, Randomized, Open label Three Armed Clinical study to assess the role of Vasa Ghana(whole Aqueous extract of Adhatoda vasica), Guduchi Ghana (whole Aqueous extract of Tinospora cordifolia) and Vasa-Guduchi Ghana (whole Aqueous extract of Adhatoda vasica &Tinospora cordifolia combined) in management of symptoms and preventing the progression of severity of the disease in SARS-CoV2 tested positive asymptomatic and mild COVID-19 cases

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Prof Tanuja Manoj Nesari
Designation	Director, AIIA
Affiliation	All India Institute of Ayurveda
Address	Ground floor Admininstration block , All India Institute of Ayurveda , New Delhi South West DELHI 110076 India
Phone	9958817145
Fax
Email	tnesari@hotmail.com

Details of Contact Person
Scientific Query

Name	DR BHAVANA PRASHER
Designation	Senior Scientist, at CSIRâ€™s Ayurgenomics Unit- TRISUTRA
Affiliation	CSIRâ€™s Ayurgenomics Unit- IGIB
Address	CSIRâ€™s Ayurgenomics Unit- TRISUTRA South Campus, Mathura Road, Opp:, Sukhdev Vihar, New Delhi, Delhi 110025 South West DELHI 110025 India
Phone	9899107338
Fax
Email	bhavana.p@igib.res.in

Details of Contact Person
Public Query

Name	Dr Meera K Bhojani
Designation	Associate Professor ,Dept. of Kriya Sharira AIIA
Affiliation	All India Institute of Ayurveda
Address	Room No. 302 , 3rd floor Academic block , All India Institute of Ayurveda , New Delhi South West DELHI 110076 India
Phone	9990247410
Fax
Email	meera.samhita@aiia.gov.in

Source of Monetary or Material Support

Ministry of AYUSH, Govt. of India

Primary Sponsor

Name	Ministry of AYUSH Govt of India
Address	GPO Complex, AYUSH BHAWAN, B Block, INA Colony, New Delhi, Delhi 110023
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Tanuja Nesari	All India Institute of Ayurveda	IPD 4th floor ,Hospital block , Covid Health centre All India Institute of Ayurveda South West DELHI	9958817145 tnesari@hotmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethical comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: B972\|\|Coronavirus as the cause of diseases classified elsewhere,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Guduchi Ghana (Aqueous extract of Tinospora cordifolia)	The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test positive will be administered Guduchi Ghana (whole water soluble extract): 500mg BD 15 min. before meals for 14 days
Intervention	Vasa Ghana (Aqueous extract of Adhatoda vasica),	The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test positive will be administered Vasa Ghana (whole water soluble extract): 500mg BD 15 min. before meals for 14 days
Intervention	Vasa- Guduchi Ghana (whole water soluble extract): 500mg (250 mg each of Vasa and Guduchi)	The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test positive will be administered Vasa- Guduchi Ghana (whole water soluble extract): 500mg (250 mg each of Vasa and Guduchi) BD 15 min. before meals for 14 days

Inclusion Criteria

Age From	19.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or mild symptoms Voluntariness to participate in the trial Patients who are able to take the drug orally and comply with study procedures. Women of childbearing potential must have a negative urine pregnancy test prior to study entry. Age 19-65 years

ExclusionCriteria

Details

COVID patients with symptoms classified as moderate, severe or critical. Patients
suffering from severe COVID-19 disease as judged by a physician and fulfilling
at least two of the following three criteria:
Respiratory distress at room ambience (â‰¥30 breaths per min)
SaO2/ SpO2 < 90% on room air and requiring oxygen support for more
than one hour to normalize.
PaO2/ FiO2 < 300 mmHg.
Any of the known COVID-19 complications and emergency procedures
which may require shift/admission in intensive care unit such as
respiratory failure, adult respiratory distress syndrome, requirement of
oxygen support for more than 1 hour, requirement of mechanical
ventilation, septic shock, or severe non-respiratory organ dysfunction or
failure. (Adapted and modified from the reference: Yang Liu et al. Lancet
Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2)
Individuals with uncontrolled, unstable co-morbidities/ co-existent medical illness
such as diabetes, hypertension, cardiac disorders, liver, kidney disorders and lung
disorders or other disease of concern that may put the patient at increased risk
during the study.
Persons with serious complications of diseases such as cancer, heart disease, stroke,
disabilities, mental illnesses, etc. and who are considered to be excluded from the
study as evaluated by the investigators.
Individuals with pre-existing respiratory conditions
Immuno-compromised individuals or those on immune suppressants. History of
immune suppression: solid organ or bone marrow transplant, use of immune
suppressive anti-metabolic and biologic agents, intrinsic immune deficiencies, HIV
infection.
Patients on or requiring parenteral nutrition
Patients with known sensitivity or contraindication to any of the study medication.
Pregnant and lactating females
Patients who are likely to worsen or planed ICU admission or ventilator support
due to any reason.
COVID-19 positive cases participating as subjects in the interventional arm of
other COVID-19 clinical trials.
Participation in a drug interventional clinical drug trial of any nature in the three
month period preceding onset of COVID-19.
Patients on any kind of Ayurveda treatment or any other alternative and
complementary medicinal systems such as Homeopathy, Unani, Siddha and in
particular requiring oral therapy of any kind.
Physician decision that involvement in the study is not in the patientÂ´s best interest.
Patient with persistent vomiting more than three episodes of vomiting in 12 hours,
preventing adequate oral hydration.
Patient with known active hepatitis, and definite bacterial or fungal infections.
Patient with altered mental state.
Patient taking concomitant medication associated with QTc-interval prolongation,
which cannot be withdrawn prior to study drug administration.
Patient with history of evidence of chronic interstitial infiltration at imaging.
Patient with history of serology tests positive for hepatitis B, hepatitis C, or human
immune deficiency virus.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parameters	Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parameters

Secondary Outcome

Outcome	TimePoints
Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parameters	(days from admission; days from first testing positive; days from first noticed symptoms)

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

21/09/2020

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The coronavirus 2019 (COVID-19) pandemic caused by a severe acute respiratory coronavirus (SARS-CoV-2) has become a global health issue. To date, it has infected more than 10 million people with 500 thousand fatalities worldwide. In India alone, the total number of positive cases

has reached 1.4 million (27 th July â€™20). Ayurveda describes therapeutic usage of AV in form of aqueous extract (Kwath). The effect

of aqueous extract of AV on expression of molecular markers and genes associated with asthma and other hypoxia induced inflammation phenotypes has not been studied in detail. Similarly, the second herb, Tinospora cordifolia (Thunb.) Miers (TC), commonly named

Guduchi, is known for its immense applications in various diseases. The discovery of active components from the plant and their biological function in disease control gained a keen interest in the research field to explore and uncover the mechanism of its multi-dimensional

effect. As per Ayurveda, it is the best Rasayana. Besides, medicinal applications of T. cordifolia in countering various disorders and

conditions. It shows antioxidant, hepatoprotective, cardiovascular protective, anti- inflammatory, anti-pyretic, a thrombolytic agent, anti-microbial, and anti-cancer effects

A particular focus has been made on its health benefits in treating endocrine and metabolic disorders and its potential as an immune booster. Therefore, it would be interesting to see the direct effect of AV and TC individually and their combinatorial effect on SARS-CoV2 infection mediated molecular and clinical phenotype in patients.