Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Shahid Beheshti University of Medical Sciences

Status

Completed

Conditions

Hemodialysis Complication

Hemodialysis-Induced Symptom

Treatments

Drug: Curcumin Pill

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03144882

TUR21324354

Details and patient eligibility

About

Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP, IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.

Full description

Hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.Seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . Trial group received turmeric and control group received placebo for 12 weeks. Biochemical determinations included levels of serum albumin (Alb), potassium (K) ,blood urea nitrogen (BUN), serum creatinine (Cr), IL-6 level, TNF- α , and liver function tests and hs-CRP at the start and end of the study were measured.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Males or females undergoing maintenance hemodyalisis,

Age ≥18 year
Clinically stable and receiving adequate hemodialysis defined by a single pool Kt/V≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment,
Diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control.

Exclusion Criteria:

Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)
- Critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit)
- Active vasculitis
- Severe congestive heart failure (New York Heart Association class IV)
- Severe chronic systemic infectious or inflammatory disease
- Liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal)
- Known or suspected allergy to trial product(s) or related products
- Treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening
- Recent or current use of anti-inflammatory corticosteroids agents
- A scheduled renal transplantation within the trial period