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Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Primary Purpose

Hemodialysis Complication, Hemodialysis-Induced Symptom

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Curcumin Pill

Placebo

About this trial

This is an interventional prevention trial for Hemodialysis Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention

placebo

Arm Description

the trial group (n =35 )

control group

Outcomes

Primary Outcome Measures

Mean Interlukin-6 Levels

blood even

Secondary Outcome Measures

Full Information

NCT ID

NCT03144882

First Posted

May 5, 2017

Last Updated

May 8, 2017

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03144882

Brief Title

Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Official Title

Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 2, 2015 (Actual)

Primary Completion Date

February 2, 2016 (Actual)

Study Completion Date

February 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis Complication, Hemodialysis-Induced Symptom

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Active Comparator

Arm Description

the trial group (n =35 )

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

control group

Intervention Type

Drug

Intervention Name(s)

Curcumin Pill

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Mean Interlukin-6 Levels

Description

blood even

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients

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