Hemodialysis ComplicationNCT03144882
Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
A study testing Curcumin Pill in people with Hemodialysis Complication and Hemodialysis-Induced Symptom, run by Shahid Beheshti University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Hemodialysis-Induced Symptom
- What is being tested?
- Curcumin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 2 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 10Show fewer
- 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
About this study
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.
Read the 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.
- Being tested
- Curcumin Pill, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin PillDrug
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
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | the trial group (n =35 ) Receives: Drug: Curcumin Pill |
| placebo | Placebo comparator | control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Interlukin-6 Levels
blood even
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start2 Feb 2015
- Primary completion2 Feb 2016
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144882
- Sponsor's protocol ID
- TUR21324354
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03144882
- Acronym / sponsor ID
- TUR21324354
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: Curcumin Pillthe trial group (n =35 ) |
| placebo | Placebo comparator | Drug: Placebocontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin PillTurmeric 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 | Drug | intervention |
| Placeboplacebo | Drug | placebo |
Primary outcome
Mean Interlukin-6 Levels
Time frame: one year
blood even
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Pill in people with Hemodialysis Complication and Hemodialysis-Induced Symptom, run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Interlukin-6 Levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.