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Siddha formulations for the prevention of COVID-19 infection

NON RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SIDDHA MEDICINES NILAVEMBU KUDINEER AND KABASURA KUDINEER IN THE MANAGEMENT OF COVID 19 PATIENTS: AN INVESTIGATIVE STUDY

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026673
Enrollment
60
Registered
2020-07-18
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: B999- Unspecified infectious disease

Interventions

Intervention1: As standard treatment suggested by WHO-ICMR (Treatment period of14days): As standard treatment suggested by WHO-ICMR (Treatment period of 14 days) Control Intervention1: As standard tre

Sponsors

Ministry of AYUSH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Laboratory confirmed COVID-19 patients with or without symptoms • Aged 20-60 years • Consenting to participate in the study and sign the informed consent • Hospitalized patients with illness of any duration with SpO2

Exclusion criteria

Exclusion criteria: • Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that need to be identified with COVID-19 • Pregnant and lactating mothers. • Patients with other systemic malignant diseases such as malignant tumors, HIV, mental illnesses, etc., which the researchers consider unsuitable for participation in the study • People who have been allergic to Siddha medicine or intolerant to taking medicine • Patients participating in other COVID-19 clinical trials • Spontaneous blood ALT/AST levels > 5 times the upper limit of normal • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR • Patients previously treated with one of the antivirals evaluated in the trial (i.e. KSK and NVK) in the past 14 days • Contraindication to any study medication including allergy • 10Participation in any other clinical trial of an experimental treatment for COVID-19Evidence of multi organ failure

Design outcomes

Primary

MeasureTime frame
â?¢Reduction in clinical symptoms like fever, cough,sore throat and breathlessness Respiratory rate - â?¤24/minute on room air; 3) Oxygen saturation - 94% on room air; (4) Cough - mild or absent on a patient reported scale Timepoint: â?¢Reduction in clinical symptoms like fever, cough and breathlessness Respiratory rate - â?¤24/minute on room air; 3) Oxygen saturation - 94% on room air; (4) Cough - mild or absent on a patient reported scale

Secondary

MeasureTime frame
1.Incidence of severe Covid19 positive cases amoung Siddha users2.incidence ofmortality due ti Covid19 amoung Siddha users3.Incidence of any other symptoms like cough,fever,sore throat etc during this study3.Requirementof treatment for symptoms developed ,if any during this period.5.ADR/AE due to use of any particular Siddha advogatesTimepoint: Time points after enrollment on day one ,clinical assessments will be done on day 3,6,9,12 and14

Countries

India

Contacts

Public ContactDrCSavariraj SahayamMDPhD

Thanjavur Medical College

surgeondrkarthig81@gmail.com9655990744

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026