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A study of a food supplement to reverse feeling of tiredness after a viral infection

A Prospective Randomized, Placebo-Controlled, Phase IV Study to Evaluate the Efficacy of CelWel in Patients with Postviral Fatigue Syndrome - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056433
Enrollment
200
Registered
2023-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G933- Postviral fatigue syndrome

Interventions

Intervention1: CelWel Product Administration: CelWel product-containing natural extracts of tinospora cordifolia, a common herb that goes with the local name of guduchi, combined with pepper extracts

Sponsors

Carmel Research Consultancy Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female subjects over 18 years of age 2.Willingness to follow the protocol requirements as evidenced by written, informed consent. 3.Mentally, physically and legally eligible to give informed consent 4.Willingness to complete study questionnaires. 5.Able to use a smartphone and an mobile application for delivering feedback every week on symptoms

Exclusion criteria

Exclusion criteria: 1.Patients with pre-existing or other severe systemic diseases that necessitate long-term medication. 2.Any vascular or systemic disorder which could affect any of the efficacy assessments. 3.Subjects received other medication (anti-viral) within 36 hours before entry into the study. 4.Evidence of significant uncontrolled co-morbid disease, which in the investigators opinion, would jeopardize patient participation. 5.Patients hospitalized or requiring oxygen support

Design outcomes

Primary

MeasureTime frame
Changes in fatigue severity scale (FSS) score from baseline to different assessment points [Duration: 4 weeks]Timepoint: At day 0, day 7, day 14, day 21 & day 28.

Secondary

MeasureTime frame
1.Changes in the COVID-19 Yorkshire Rehabilitation Screening (C19-YRS) score on physical functions & structures, activity limitations, and personal factors from baseline to different assessment points. 2.If any incidence of adverse events (AEs) during treatment period. Timepoint: At day 0, day 7, day 14, day 21 & day 28.

Countries

India

Contacts

Public ContactProf Dr Alben Sigamani

Carmel Research Consultancy Pvt Ltd

dralbens@myrescon.com8884431444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026