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An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19

An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025768
Enrollment
200
Registered
2020-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B342- Coronavirus infection, unspecified

Interventions

Intervention1: Kabasura kudineer, Amukkara churnam and Nellikai ilagam: Kabasura kudineer: 10gms of drug boiled with 240ml of water will be reduced to 60 ml, filtered and consumed within 3 hours. Deco

Sponsors

National Institute of Siddha
Lead Sponsor
Chengalpattu Medical College Hospital
Collaborator
Food Safety Department District Administration
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Male, Female and Transgenders. ï?· Age between 18 to 85 years ï?· COVID 19 positive asymptomatic / pre symptomatic, mild, moderate and severe COVID patients. ï?· Willing to consent to the study.

Exclusion criteria

Exclusion criteria: Patients who cannot take food or drugs orally. High risk groups (Patients with Complications of Diabetes â?? DKA, DN, Severe Heart diseases and Pregnancy) Patients with other severe medical conditions requiring intensive management. Other viral pneumonia Patients who have received organ transplantation in the past 6 months or planning surgery Patients with severe or critical covid-19 infections. Patients with any active malignancy Patients who have severe underlying diseases that affects survival, including blood diseases, dyscrasia, active bleeding, severe malnutrition, etc. Patients with allergic constitution, or patients allergic to investigational products Patients with a history of positivity for HIV, Hepatitis B and Hepatitis C at screening. Critical patients with life expectancy Septicemia / Multi-organ failure Syndrome (MODS). Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. Patients participating in other COVID 19 trials.

Design outcomes

Primary

MeasureTime frame
Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. RT PCR conversion within first week with accelerated recovery as compared to control groupTimepoint: 6 months

Secondary

MeasureTime frame
Possible reduction of viral load data in subsets of both groups both at baseline and at 7 days, and14 days or at recovery or 30 days whichever is earlier.. ï?· Sub group analysis for male, female and Age groups will also be studied in each group. Number of days on treatment before recovery and case fatality rate if any will be documented.Timepoint: 6 MONTHS

Countries

India

Contacts

Public ContactDr G J CHRISTIAN

NATIONAL INSTITUTE OF SIDDHA,

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026