A Randomized, Comparative Clinical Study to Evaluate the Activity of CurvicTM Formulation for Management of SARS-COV-2 Infection (COVID-19)
Dound et al., Journal of Clinical Trials, S3:004
Dound et al., A Randomized, Comparative Clinical Study to Evaluate the Activity of CurvicTM Formulation for Management of.., Journal of Clinical Trials, S3:004
RCT 200 COVID-19 positive patients in India, 100 treated with Curcumin, Vitamin C, Vitamin K2-7, and L-Selenomethionine, showing faster recovery with treatment.
This study is excluded in the after exclusion results of meta
analysis:
potential randomization failure.
Dound et al., 16 Nov 2020, Randomized Controlled Trial, India, peer-reviewed, 5 authors, this trial uses multiple treatments in the treatment arm (combined with vitamin C, vitamin K2-7, and l-selenomethionine) - results of individual treatments may vary.
Abstract: OPEN
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Journal of Clinical Trials
Research Article
A Randomized, Comparative Clinical Study to Evaluate the Activity of
Curvic TM Formulation for Management of SARS-COV-2 Infection
(COVID-19)
Yogesh Arun Dound1*, Sagar Mandlik5, Shrikant Suryavanshi2, Rajesh Sehgal3, Ajay Naik4
Department of Research & Development, Shreepad Shree Vallabh SSV Phytopharmaceuticals, C OO, Particle L ife Sciences Pvt. L td, Mumbai,
2
Maharashtra, India; Consulting Physician,Nashik, Maharashtra, India; 3 Department of Research & Development, Pharma Instinct, Noida,
5
Uttar Pradesh, India; 4 Administration, Rukmini Enterprises, Mumbai, Maharashtra, India; Chest Physician, Radiant Plus Hospital, Nashik,
Maharashtra, India
1
ABSTRACT
COVID-19 outbreak has put forward a huge challenge in front of researchers across the globe. Non availability of any vaccine
or drug has worsened the situation and it has become a worst pandemic of modern times. Keeping scientific rationale and
results of in silico studies, Researchers at Shreepad Shree Vallabh SSV Phytopharmaceuticals (SSV) have developed formulation
containing natural ingredients viz Curcumin, Vitamin C, Vitamin K2-7, Selenomethionine and Zinc.
Objective: To evaluate role of Curvic TM in the management of COVID-19 and its tolerability in comparison with standard
treatment available from Ministry of Health and Family Welfare (MOHFW).
Study design and methodology: In a randomized, two arm, comparative study, COVID-19 positive patients (n=200) were
enrolled during the month of August and September 2020 from Radiant Plus Hospital, Nashik, Maharashtra, India. The
enrolled patients were administered either Curvic TM 500 mg tablets twice daily or given standard treatment protocol
designed by MOHFW for 10 days. The patients were evaluated for decrease in oral temperature; SpO2 and VAS score for cough
and respiratory distress. The underlying mechanism was assessed by evaluating markers such as Interleukin-6, Homocysteine,
D-dimer, Ferritin and C Reactive Protein.
Results: In the Curvic TM group, within two days, temperature reduced considerably to afebrile level in all the subjects
and remained afebrile till end of study. While in the standard treatment group, temperature reduced to afebrile stage in
all the subjects by 4 days and there after remained afebrile till end of study. The elevated levels of serum Interleukin-6,
Homocysteine, Di-dimer, Ferritin and C-Reactive Protein at baseline dropped considerably within normal limits within 10
days in the Curvic TM group in comparison to standard treatment group.
Conclusion: Curvic TM has shown for the first time to be useful in management of COVID-19 positive patients along
with improvement in the immunity, within 48 hours of starting treatment. Curvic TM was well tolerated without any side
effects in any of the patients treated.
Keywords: Curcumin; COVID-19; IL-6; Homocysteine; SARS-CoV
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