Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03144882

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 2, 2015

Actual Primary Completion Date :

Feb 2, 2016

Actual Study Completion Date :

Feb 2, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean Interlukin-6 Levels [one year]
blood even

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

nooshin dalili, Assistant Professor of SBMU, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03144882

Other Study ID Numbers:

TUR21324354

First Posted:

May 9, 2017

Last Update Posted:

May 9, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Curcumin

Study Results

No Results Posted as of May 9, 2017