Clinical trial of herbal supplement as an immunomodulator in adult Covid 19 positive patients.

Phase 2

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/06/026187

Lead Sponsor: Mr Ghanshyam Goti

Brief Summary: The recent outbreak of coronavirus disease in 2019 (COVID-19) caused by SARS-CoV-2 has raised global health concerns. There are many leads in herbs and phytoconstituents which bear scattered pieces of evidence that can prove those beneficial in the prevention, mitigation, and treatment of corona infection. In the background of a deficit of definite antiviral or vaccine for prevention, it is a need of an hour to compile such evidence and come up with products for working in the management of corona infection. GP Lifehealthcare Pvt.Ltd. has developed and planned clinical trial to validate the safety and efficacy of ACT 12 and 13 in mild to moderate COVID 19 patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients admitted with RT-PCR confirmed COVID-19 illness.
Age > 18 & < 65 years of either sex Mild to Moderately Covid 19 disease (NEWS score â‰¤ 8) Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.

Exclusion Criteria

Pregnant women Breastfeeding women Requiring ICU admission at the screening Patients above 65 years of age and below 18 Years Past History of MI, Epileptic episodes Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at the screening Any other condition by which subject proves unfit from investigator perspective Not giving consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19	Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale	Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study
Serum levels of CRP, IgM, IgG	Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study
Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale.	Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study

Secondary Outcome Measures

Name	Time	Method
Change in National Early Warning Score.	Hematological parameters like WBS, HB and platelet count etc.

Trial Locations

Locations (1): Pimpri Chinchwad Municipal Corporations YCM Hospital
🇮🇳
Pune, MAHARASHTRA, India
Pimpri Chinchwad Municipal Corporations YCM Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Tushar V Patil
Principal investigator
8888844203
tvpatil71@gmail.com