A study of a food supplement to reverse feeling of tiredness after a viral infectio
- Conditions
- Health Condition 1: G933- Postviral fatigue syndrome
- Registration Number
- CTRI/2023/08/056433
- Lead Sponsor
- Carmel Research Consultancy Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br/ ><br>2.If any incidence of adverse events (AEs) during treatment period. <br/ ><br>Timepoint: At day 0, day 7, day 14, day 21 & day 28.