Health TrialsbyHealthPanel

The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients

ConditionHemodialysis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Guadalajara

About this trial

The goal of this clinical trial is to learn if curcumin can lower the inflammation in participants with chronic kidney disease (CKD) undergoing hemodialysis (HD).

The main questions it aims to answer are:

Does curcumin lower can lower profinflamatory markers in participants with CKD on HD?

Researchers will compare curcumin to a placebo (a look-alike substance that contains no drug) to see if curcumin works to help the treatment in participants with CKD on HD.

Researchers will compare nutritional status and side effects after taking the supplement.

Participants will:

Take the curcumin or a placebo twice a day for 3 months Visit the clinic once every week for checkups and tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of both sexes undergoing dialysis or hemodialysis.

Aged 18 years or older.

Clinically stable and receiving hemodialysis or dialysis for at least three months before study enrollment.

Continuation of pharmacotherapy as prescribed by their physician.

Disqualifiers

Active malignant disease (diagnosed within the past five years).

Critical illness requiring respiratory or circulatory support.

Severe congestive heart failure (NYHA class IV).

Severe chronic systemic infectious or inflammatory disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Curcumin (Longvida™)

    Dietary supplement

    patients will be suplemented during 3 months with longvida, 2 cap /8 hours

  • Placebo

    Drug

    one capsules every 8 hours during 12 weeks

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: case groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Interleukin Interleukin-6

basal meassurement of Interleukin-6 in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
before supplementation
2

Interleukin Interleukin-6

final meassurement of Interleukin-6 nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
after 3 months of supplementation
3

TNF-α: Tumor Necrosis Factor-alpha

basal meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
before supplementation
4

TNF-α: Tumor Necrosis Factor-alpha

final meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)

Time frame
after 3 months of supplementation

Secondary outcomes

1

Urea

Urea meassurement in mg/dL using a biochemistry analyzer

Time frame
before supplementation
2

Urea

Urea meassurement in mg/dL using a biochemistry analyzer

Time frame
after 3 months of supplementation
3

leukocyte count

leukocyte count (cells/µL) using an automated blood cell counter

Time frame
before supplementation
4

leukocyte count

leukocyte count (cells/µL) using an automated blood cell counter

Time frame
after 3 months of supplementation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Guadalajara

Lead sponsor

Hospital Civil de Guadalajara

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: