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An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19

An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025762
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: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Kabasura kudineer
Amukkara choornam
Nelikai legiyum: KS kudineer will be administered twice a day in asymptomatic COVID patients
and will be administered thrice a day in symptomatic individuals just before or after food. Apart from this medication, Convalescent medication is prescribed namely Amukkara choornam 2gms bid and Nell

Sponsors

National Institute of Siddha
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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 positive for HIV, Hepatitis B and Hepatitis C at screening.Critical patients with life expectancy <48 hours. 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
Outcome would be measured through Reduction of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points.Timepoint: 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.Reduction in Signs and symptoms like Fever, cough, breathlessness, and improvement in O2 saturation (SpO2) and PaO2/FiO2Timepoint: 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 4, 2026