Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis Complication; Hemodialysis-Induced Symptom
• Interventions: Drug: Curcumin Pill; Drug: Placebo

• Registration Number: NCT03144882
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-02-02
• Primary Completion: 2016-02-02
• Study Completion: 2017-02-02
• Status Verified: 2017-05
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-09
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Curcumin Pill	the trial group (n =35 )
placebo	Placebo	control group

Primary Outcome Measures

Name	Time	Method
Mean Interlukin-6 Levels	one year	blood even