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:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT07118059
Eligibility Criteria:
Inclusion Criteria:
* adults aged 18-45 years
* laboratory confirmed Pulmonary TB defined as a hard copy of a sputum result detected by WHO recommended assay or mycobacteria culture.
* Women of childbearing potential with a negative pregnancy test on enrollment
* All participant irrespective of HIV status who consent to have a HIV test during enrollment.
Exclusion Criteria:
* Comorbid condition with treatment of NSAIDS is indicated
* Institutionalized or incarcerated individuals
* Those on Multiple drug resistance treatment for more than 4 days within the past 6 months or within 1 month to prior to TB treatment initiation
* Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn
* show lab safety values: AST or ALT \> x3 upper limit of normal (ULN) or Total bilirubin \> 2x the ULN, Neutrophils ≤ 700/mm³, Platelets \< 50,000/mm³, Haemoglobin \< 8 g/dL, Serum creatinine \> 2× ULN.
* Are receiving or planning treatment with any of the following in the 3 months before or during the trial:
Anticoagulants Immune-modulating therapy (e.g., cancer treatment, oral/inhaled corticosteroids) Antacids or proton pump inhibitors (PPIs)
* Have a known allergy or sensitivity to fish or fish oil.
* Have a recent history (within 2 years) or current clinical evidence of:
Peptic ulcer disease or GI bleeding Coagulopathy or bleeding disorders Kidney or liver disease requiring hospitalisation Cardiovascular disease or significant risk factors for it
-Are HIV-positive and meet any of the following: CD4 count \< 100 cells/mm³ Viral load \> 400 copies/mL (if on ART) Not yet on ART but are expected to initiate treatment during the 8-week intervention phase
* Report high-risk alcohol use (average \>4 units/day or binge drinking patterns)
* Have any other medical condition or situation that, in the investigator's opinion, may interfere with protocol adherence or data interpretation.
* Plan to relocate from the study area within the next 3 months.
* Are currently using omega-3 or omega-6 supplements and are unwilling to stop for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07118059
Study Brief:
Protocol Section:
NCT07118059