A Randomized controlled Clinical Trial to determine the efficacy of Siddha drugs in COVID 19 patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/06/025763
- Lead Sponsor
- National institute of Siddha
- Brief Summary
There is a sudden outbreak of Novel Coronavirus disease all over the world. As there is no direct drug against the disease spread, it is a time needed action of usage of AYUSH drugs in management. Various drugs have been cited by AYUSH ministry and State government for management of the disease spread like Kabasura kudineer, Amukkara choornam etc. This study will be conducted based on the Preliminary analysis and literature evidence of drugs namely Kabasura kudineer, Amukkara choornam, Thalisathi choornam and Adathodai manapaggu, Maldevi chenduram, Thippili rasayanam etc. among the sample consists of 18 years and above COVID-19 – RT PCR +ve patients declared by Tamil Nadu Government accredited labs admitted to COVID 19 ward at SRMMCH / NIS or quarantined Govt. facilities or at home quarantine. The subjects will be randomly allocated to both the test or control groups. This study is carried out to analyze document scientifically the therapeutic efficacy of these drugs against Novel Corona virus disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
- Male, Female and Transgenders.
- ï‚· Age between 18 to 85 years ï‚· COVID 19 positive asymptomatic / pre symptomatic, mild and moderately and severely symptomatic patients.
- ï‚· Willing to consent to the study.
- High risk groups (Patients with Complications of Diabetes, Heart diseases, Cancer and Pregnancy) ï‚· Multi organ failure Syndrome (MODS).
- ï‚· Patients participating in other COVID 19 trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome would be measured through Reduction of symptoms and 6 months Recovery of patients from COVID 19 disease in a time bound manner.Conversion of RT PCR negative within first week of accelerated recovery 6 months
- Secondary Outcome Measures
Name Time Method Possible reduction of viral load data in subjects both at baseline and at 7 days, and 14 days or at recovery or 30 days whichever is earlier.. ï‚· Number of days on treatment before recovery and Case fatality rate will also be noted.
Trial Locations
- Locations (1)
SRM Medical college Hospital and Research centre
🇮🇳Kancheepuram, TAMIL NADU, India
SRM Medical college Hospital and Research centre🇮🇳Kancheepuram, TAMIL NADU, IndiaProf M Meenakshi SundaramPrincipal investigator9940266442mmssiddha@gmail.com