End-Stage Renal DiseasePhase 2NCT02671162
Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus
A Phase 2 study testing Wheat and Fumaria in people with End-Stage Renal Disease and Pruritus, run by Shiraz University of Medical Sciences.
Trial summary
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-Stage Renal Disease, Pruritus
- What is being tested?
- Wheat and Fumaria
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 2016
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis patients
- Suffering from pruritus for at least 6 weeks
- Have not responded to other drugs
- visual analogue scale (VAS) equal or more than 4
Who cannot join
- Liver disease
- Respiratory disease
- Dermatological disease
- Hemoglobin less than 10
- Cholestasis
- Malignancies
About this study
Official title: Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
Read the detailed description
Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).
- Conditions
- End-Stage Renal Disease, Pruritus
- Being tested
- Wheat, Fumaria
- Keywords
- Pruritus, End-Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheatDrug
3 times a day each time 2 capsules before eating meal for 8 weeks.
FumariaDrug
3 times a day each time 2 capsules before eating meal for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Wheat | Placebo comparator | Placebo capsule/ 2 capsule 3 times per day Receives: Drug: Wheat |
| Fumaria | Active comparator | Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day. Receives: Drug: Fumaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Pruritis as measured by a visual analogue scale (VAS)
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
Measured: 3 months
Secondary outcomes (3)
Serum Interferon-gamma level
Measured: 4 months
Serum IL-4 level
Measured: 4 months
Serum high-sensitive C reactive protein (hs-CRP)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahimeh Akrami, Shiraz University of Medical Sciences
- Investigators
- Jamshid Roozbeh, MD, Study chair, Shiraz University of Medical SciencesPouya Faridi, PhD, Study director, Shiraz University of Medical SciencesRahimeh Akrami, PhD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671162
- Sponsor's protocol ID
- IRCT2015080110410N2
- Status last verified
- Jan 2016
- First submitted
- 29 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3.
PubMed 21372257Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
PubMed 16249205Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02671162
- Acronym / sponsor ID
- IRCT2015080110410N2
- Conditions
- End-Stage Renal Disease, Pruritus
- Keywords
- Pruritus, End-Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
Detailed description
Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat | Placebo comparator | Drug: WheatPlacebo capsule/ 2 capsule 3 times per day |
| Fumaria | Active comparator | Drug: FumariaFumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hemodialysis patients
- Suffering from pruritus for at least 6 weeks
- Have not responded to other drugs
- visual analogue scale (VAS) equal or more than 4
Key exclusion criteria (6 listed)
- Liver disease
- Respiratory disease
- Dermatological disease
- Hemoglobin less than 10
- Cholestasis
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 |
|---|---|---|
| Wheat3 times a day each time 2 capsules before eating meal for 8 weeks. | Drug | Wheat |
| Fumaria3 times a day each time 2 capsules before eating meal for 8 weeks. | Drug | Fumaria |
Primary outcome
Severity of Pruritis as measured by a visual analogue scale (VAS)
Time frame: 3 months
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
3 secondary outcomes
Serum Interferon-gamma level
Time frame: 4 months
Serum IL-4 level
Time frame: 4 months
Serum high-sensitive C reactive protein (hs-CRP)
Time frame: 4 months
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 2 Feb 2016.
- Background: PubMed 21372257Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3.
- Background: PubMed 16249205Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
- Itching, Kidney Diseases, Kidney FailureLink provided by the sponsor.
- FumariaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Jamshid Roozbeh, MD study chair
Shiraz University of Medical Sciences
Pouya Faridi, PhD study director
Shiraz University of Medical Sciences
Rahimeh Akrami, PhD principal investigator
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wheat and Fumaria in people with End-Stage Renal Disease and Pruritus, run by Shiraz 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 4 inclusion and 6 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 2 Feb 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Severity of Pruritis as measured by a visual analogue scale (VAS) (time frame: 3 months). 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 NCT02671162, which also lists 3 linked publications.
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 2 Feb 2016.