Working…
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered SARS-CoV-2.
Protect yourself and others from infection by washing your hands, wearing masks or using an alcohol based rub frequently and not touching your face.

CUReD:  CSIR Ushered Repurposed Drugs -  A website that provides information on CSIR Partnered Clinical Trials.

   Details of Tinospora cordifolia & Adhatoda vasica

   (individually and in combination)
Name of trial 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.
CSIR lab/s involved Industry Sponsor/s & Scientific Collaborator/s Clinical Trial Site/s
Institute of Genomics & Integrative Biology (IGIB)

 

 PI- Dr. Bhavana Prasher (Principal scientist, IGIB)
Co-PI- Dr. Anurag Agrawal (outstanding scientist, Director, IGIB)
Co-PI – Dr. Mitali Mukerji (Chief Scientist, IGIB)		 PI- Dr. Tanuja Nesari, Director,
All India Institute of Ayurveda, New Delhi
Type of Drug Vasa Ghana (Adhatoda Vasica Whole extract)
Guduchi Ghana (Tinospora cordifolia whole extract)
Combined Vasa and Guduchi ghana
IP Status of Drug/s
Classical herbal formulations of Ayurveda
Mechanism of Action & Scientific rationale for Covid-19
Adhatoda vasica extract has anti-inflammatory, anti-hypoxic effects observed in preclinical studies, in vitro and in vivo. The outcomes of hyperinflammation- hypoxia such as hemostasis, fibrosis, sepsis, which are observed in COVID19 patients have been studied in animal models and with  desirable outcomes post treatment in modulating host response to SARSCOV2 viral infection.
Tinospora cordifolia has immunomodulatory activity reported in literature.
Combination therapy or Monotherapy

Single herbal extracts and one arm with combination

Trial design - Randomized, Open label Three Armed

Health Condition / Problems Studied

COVID19 –positive cases

 Health Type Condition
Covid-19

To Evaluate the Efficacy and Safety in asymptomatic and mild symptomatic COVID-19  positive patients  

Number of trial sites       

Number of arms              

Number of patients         

01
03
50 in each arm total- 150 patients

End points (primary and secondary)

  • Time to test COVID-19 Negative (days from admission; days from first testing positive; days from first noticed symptoms)
  • Progress from asymptomatic to mild to moderate (days from admission; days from first testing positive; days from first noticed symptoms)
  • Progress from mild to moderate to severe or critical stages (days from admission; days from first testing positive; days from first noticed symptoms, days from change in status from asymptomatic to symptomatic).
  • Time to point of referral (days from admission; days from first testing positive; days from first noticed symptoms)
  • Clinical improvement in individual symptoms :
 Key Secondary end point-
  • Changes in all the Lab parameters
  • Length of time to clinical improvement/disease progression
  • Duration of fever and respiratory symptoms
  • Requirement of SOS medication- reason and no.of times  Requirement of Rescue medication
  • Incidence of respiratory failure
  • Number of days of treatment and hospitalization
  • Adverse events
  • Percent mortality
Status of the trial 
 Institutional Ethics committee approval obtained,
CTRI registration done (Regn. No CTRI/2020/09/028043)
Trial drugs- Procured from NMPB
Name & details of Clinical PI/s Dr. Tanuja Nesari, Director, AIIA
Co-PI: Dr. Meera Bhojani, Associate Professor, AIIA
Co-PI: Dr. Vitthal Huddar, Associate Professor, AIIA

Back