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

Phase 2/3

Completed

• Conditions: Coronavirus infection, unspecified,

• Registration Number: CTRI/2020/06/025768
• Lead Sponsor: National Institute of Siddha

Brief Summary

COVID 19 has almost entered every part of the world. Treatments proposed are ineffective or minimally effective. Hence, it is important to find drugs in appropriate time. Various Siddha drugs are  proposed by the Siddha fraternity to combat COVID 19 disease after analyzing its nature. They are to be analyzed and proven clinically through this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Study Completion: 2020-11-12
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

• Patients who cannot take food or drugs orally.
• High risk groups (Patients with Complications of Diabetes – 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 <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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 group	6 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chengalpattu Medical College Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Chengalpattu Medical College Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr G J CHRISTIAN

Principal investigator

9962545930

christianvijila@gmail.com