A clinical trial to study the effect and safety of the Siddha medicines in patients with Corona Virus disease

A prospective, non-randomized, single-arm interventional study to assess the safety and efficacy of Siddha Sasthric Medicines â?? Fixed Regimen in the prevention of COVID-19 disease progression of asymptomatic, and mild at Siddha COVID Care Centre, Chennai, 2020 (SSM-FiRe) - SSM-FiRe

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026471

Enrollment

Registered

2020-07-10

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: Kaba Sura Kudineer: 60ml BD for 14 days Intervention2: Tab. Amukkarachooranam: 2 BD for 14 days Intervention3: Tab. Athimathuram: 2 BD for 14 Days Intervention4: Tab. Brahmanandha Baira

Eligibility

Inclusion criteria

Inclusion criteria: COVID -19 Positive as determined by RT-PCR or other approved commercial or public health assay Willing to provide written/digital informed consent. COVID - 19 Positive with no clinical signs COVID - 19 Positive with mild symptoms â?? Fever, Cough, Sneezing, Sore Throat, Throat Pain, Malaise, Tiredness

Exclusion criteria

Exclusion criteria: Pregnant and lactating females COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation Chronic Renal Failure requiring dialysis (eGFR Known cases of uncontrolled Diabetes ( >10% HbA1c) Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening Subjects having immune-compromised status like HIV, Hepatitis, Tuberculosis, Cancer, etc. Participants taking Steroid treatment and or any kind of immunosuppressive therapy Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. Participants having a past history of allergy to Siddha medicine. Participants with Hb - <7 g/dL

Design outcomes

Primary

Measure	Time frame
Reduction in incidence of clinical symptoms of COVID-19 or Negative conversion of SARS-CoV-2Timepoint: 14 Days	—

Secondary

Measure	Time frame
To determine the safety of the SSM-FiRe. To determine the Immune assessment of the patients through Siddha Yakkkaiyin Ilakkanam (Validated YI Tool-Exploration). To explore the effect of interventional drug on immunity through laboratory investigation of immune markers. To document the ADR/AE for the interventional Drug SSM-FiRe, if any To document the length of the stay at study centreTimepoint: 14 Days	—

Measure

Time frame

To determine the safety of the SSM-FiRe. To determine the Immune assessment of the patients through Siddha Yakkkaiyin Ilakkanam (Validated YI Tool-Exploration). To explore the effect of interventional drug on immunity through laboratory investigation of immune markers. To document the ADR/AE for the interventional Drug SSM-FiRe, if any To document the length of the stay at study centreTimepoint: 14 Days

—

Countries

India

Contacts

Public ContactDr D Sasikumar

Siddha Central Research Institute

siddha2k6@gmail.com9443579540

Outcome results

None listed

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