End Stage Renal DiseaseNCT02008864
Evaluating the Effect of Senna in Uremic Pruritus
A study testing Senna in people with End Stage Renal Disease and Pruritus, run by Shiraz University of Medical Sciences.
Trial summary
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. 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?
- Senna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Sep 2012
- 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 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
Who cannot join
- Dermatological disease
- Liver disease
- Metabolic disease
About this study
Official title: Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.
- Conditions
- End Stage Renal Disease, Pruritus
- Being tested
- Senna, Placebo
- Keywords
- End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia
- 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.
SennaDrug
(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day
PlaceboDrug
Placebo tablet/ 2 times per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Wheat Receives: Drug: Placebo |
| Senna | Active comparator | Senna Receives: Drug: Senna |
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
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
Measured: 3 months
Secondary outcomes (1)
Serum IL-2 level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2012
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Faridi, Shiraz University of Medical Sciences
- Investigators
- Jamshid Roozbeh, MD, Study chair, Shiraz University of Medical SciencesAbdolali Mohagheghzadeh, PhD, Principal investigator, Shiraz University of Medical SciencesMohammad Mehdi Sagheb, MD, Principal investigator, Shiraz University of Medical SciencesArian Kamali-Sarvestani, Pharm D, Study director, Shiraz University of Medical SciencesPouya Faridi, PhD, Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008864
- Sponsor's protocol ID
- Senna in Uremic Pruritus
- Status last verified
- Mar 2015
- First submitted
- 1 Dec 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hercz 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 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients
- ClinicalTrials.gov ID
- NCT02008864
- Acronym / sponsor ID
- Senna in Uremic Pruritus
- Conditions
- End Stage Renal Disease, Pruritus
- Keywords
- End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- First posted
- 11 Dec 2013 (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.
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWheat |
| Senna | Active comparator | Drug: SennaSenna |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodialysis patients
- Suffering from pruritus for at least 6 weeks
- Have not responded to other drugs
Key exclusion criteria (3 listed)
- Dermatological disease
- Liver disease
- Metabolic disease
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 |
|---|---|---|
| Senna(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day | Drug | Senna |
| PlaceboPlacebo tablet/ 2 times per day | Drug | Placebo |
Primary outcome
Severity of Pruritis, as measured by a visual analogue scale
Time frame: 3 months
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
1 secondary outcome
Serum IL-2 level
Time frame: 3 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 1 Apr 2015.
- 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.
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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
Abdolali Mohagheghzadeh, PhD principal investigator
Shiraz University of Medical Sciences
Mohammad Mehdi Sagheb, MD principal investigator
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Senna 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 3 inclusion and 3 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 1 Apr 2015. 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?
Severity of Pruritis, as measured by a visual analogue scale (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 NCT02008864, 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 1 Apr 2015.