Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Hemodialysis Complication Clinical Trial

Official title:

Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144882
• Other study ID #: TUR21324354
• Status: Completed
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 8, 2017
• Start date: February 2, 2015
• Est. completion date: February 2, 2017

Study information

• Verified date: May 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hemodialysis-Induced Symptom
• Inflammation

Intervention

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
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Interlukin-6 Levels	blood even	one year