Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Lifestyle Management and CelWel product administration: Lifestyle Management along with administration of CelWel product-containing natural extracts of tinospora cordifolia, a common he
Sponsors
Carmel Research Consultancy Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with long covid symptoms 2.Male and female subjects ranging in age from 18 to 99 years. 3.Willingness to follow the protocol requirements as evidenced by written, Informed Consent. 4.Mentally, physically and legally eligible to give informed consent. 5.Willingness to complete study questionnaires.
Exclusion criteria
Exclusion criteria: 1.Patients with pre-existing other severe systemic disease necessitating long-term medication. 2.History of cancer, including solid tumours, hematologic malignancies and carcinoma in situ 3.Any vascular or systemic disorder which could affect any of the efficacy assessments 4.Subjects received other medication (anti-viral) within the 36 hours before entry into the study 5.Evidence of significant uncontrolled co-morbid disease which would jeopardize patient participation 6.Patients hospitalized or requiring oxygen support 7.Patients unable to take oral medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the Study in responses to the symptom score and immunological profile among participants consenting to take CelWel For symptoms score we are using the standard long covid symptoms score prescribed by various health authorities including the ministry of Health in India. For immunological profile we are performing specific multiplex cytokine tests to look for specific patterns of expression of cytokines, monocytes and T LymphocytesTimepoint: At day 0, day 8 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction of Biomarker from Baseline to End of the study.The Biomarker is Incelkine Laboratories based multplex cytokine screening. 2.Incidence of adverse events (AEs) Timepoint: 1.For Biomarkers - At day 0 and day 14 2.For Adverse Events-Day 0 to Day 14 | — |
Countries
India
Contacts
Public ContactProf Dr Alben Sigamani
Carmel Research Consultancy Pvt Ltd
Outcome results
None listed