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Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03144882
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
nooshin dalili, 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.

Condition or disease Intervention/treatment Phase
Hemodialysis Complication Hemodialysis-Induced Symptom Drug: Curcumin Pill Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : February 2, 2016
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: intervention
the trial group (n =35 )
Drug: Curcumin Pill
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 Comparator: placebo
control group
Drug: Placebo
placebo




Primary Outcome Measures :
  1. Mean Interlukin-6 Levels [ Time Frame: one year ]
    blood even



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: nooshin dalili, Assistant Professor of SBMU, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03144882     History of Changes
Other Study ID Numbers: TUR21324354
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Enzyme Inhibitors
Inflammation
Pathologic Processes
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action