Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00852020
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of CHF or COPD
* current body weight less than 6 months ago
* BMI \>=20 and \<=30 kg/m2
* CHF: LVEF \>=45% measured within the past 6 months
* symptom status equivalent to NYHA class II to IV
* biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
* on standard therapy of CHF including ACE inhibitors and beta blockers
* COPD: symptom status equivalent to GOLD standard class II to IV
* FEV1 \< 80%
* FEV1/FEV \< 70%
Exclusion Criteria:
* significant oedema in the time of screening and randomisation
* concomitant inflammatory diseases
* active infections including HIV and AIDS
* liver failure
* chronic renal failure (sCr\>1.5mg/dL) or cardiac pacemaker
* acute or chronic infections
* insulin treated diabetes mellitus
* patient with established diagnosis of cachexia
* life expectancy of less than 6 months in the opinion of the investigator
* medications that impair sex hormone synthesis, secretion or function
* patients with psychiatric diseases
* body weight loss \> 5% during the last 6 months or \> 10% during the last 10 months
* suspected allergy to any component of the investigational product(s)
* fish oil supplementation within 3 months prior to the study entry
* taking vitamin supplements in doses greater than the Recommended Daily Allowances
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00852020
Study Brief:
Protocol Section:
NCT00852020