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OpenTrials
Completed

NCT Number: NCT03144882

Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin Pill

Drug

Turmeric rhizome at first was washed and dried out in a warm and dry place for a week , then powdered rhizomes were encapsulated by Clinical Pharmacy Research Center of Shahid Beheshti University of Medical Sciences, using hard gelatin capsules. Also placebo capsules were made by the same center using Sorbitol. Curcumin level of turmeric was measured by HPTLC analysis for quantification of variability in content of curcumin

Placebo

Drug

placebo

Primary outcomes

  1. Mean Interlukin-6 Levels

    Time frame: one year

    blood even

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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