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Clinical Trials/CTRI/2020/07/026471
CTRI/2020/07/026471
Not yet recruiting
Phase 2

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

The Directorate of Indian Medicine and Homoeopathy0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
The Directorate of Indian Medicine and Homoeopathy
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
The Directorate of Indian Medicine and Homoeopathy

Eligibility 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

  • •Pregnant and lactating females
  • •COVID \- 19 Positive with Severe symptoms â?? Respiratory distress ( \>24 breath per minute), Oxygen saturation \<90% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non\-respiratory organ failure
  • •Chronic Renal Failure requiring dialysis (eGFR \< 30\)
  • •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/d

Outcomes

Primary Outcomes

Not specified

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