The efficacy of Fumaria parviflora L. versus gabapentin on uremic pruritus of patients undergoing hemodialysis: A randomized non-inferiority double-blinded active-controlled clinical trial
Investigating the effect of Fumaria parviflora L. compared to gabapentin in reducing itching in dialysis patients
Design
Non-inferiority clinical trial, with two parallel groups, randomized, double-blind, phase two on 70 patients, random sequence generator of stata software will be used for randomization.
Settings and conduct
The location of the project is Namazi Hospital Dialysis Center in Shiraz, and patients, researchers, medical personnel and data analysts are blinded.
Participants/Inclusion and exclusion criteria
Adult patients with end stage kidney disease undergoing hemodialysis who suffer from itching and their itching is not controlled and do not have a history of skin disease, seizures, or liver disease and are not allergic to Fumaria parviflora L. and Gabapentin
Intervention groups
The first group will receive two grams of ّFumaria parviflora L. per day for two months, and the second group will receive 100 mg at night, both groups will also receive a placebo to ensure randomization
Main outcome variables
Itching score of patients based on 5D itch score questionnaire; Quality of life score of patients based on DLQI questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121031011341N11
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Mohammad Hashem Hashempur
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 8476
Email address
hashempurm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Fumaria parviflora L. versus gabapentin on uremic pruritus of patients undergoing hemodialysis: A randomized non-inferiority double-blinded active-controlled clinical trial
Public title
The efficacy of Fumaria parviflora L. versus gabapentin on pruritus of patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The hemodialysis patient who has uncontrollable pruritus and now at least 1 week doesn't use any antipruritus medication
who had pruritus for at least 6 weeks
patient must have normal range phosphor and potassium in the past month
Parathyroid Hormone (PTH) must be lower than 500
measured visual analogue scale (VAS) score must be four or more
Exclusion criteria:
They do not have liver disease, a history of convulsions, or a specific skin disease that causes itching, and they do not have hemolytic blood disease.
Patients who complain of itching for the first time are not included in the study
If the patient was taking medication that interacted with gabapentin or Fumaria parviflora L., he was not included in the study
Those who are allergic to Fumaria parviflora L. or Gabapentin are not included in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using stratified block randomization method with unequal blocks (4,6,8). Block random sequence will be created using random sequence generator software. The sequence of allocation blocks will be random. The random allocation ratio will be 1:1, so that for each control, one active case will be present in the study. Based on the randomly generated sequence, each drug/placebo package will be identified with a unique code.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Gabapentin, F. parviflora, and their placebo capsules have the same color, shape, and size. Their container will be labeled by a coordinator (not included in the study team) with nonidentifiable codes. Regarding groups assignment, participants, investigators, caregivers, and data analyzers will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Vice-Chancellery of Research and Technology office, Shiraz University of Medical Sciences, Zand street, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-11-05, 1401/08/14
Ethics committee reference number
IR.SUMS.MED.REC.1401.409
Health conditions studied
1
Description of health condition studied
Uremic prururitus in dialysis patient
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Itching score in the 5-D pruritus questionnaire
Timepoint
Before the start of the intervention (the beginning of the study) and two months later (the end of the study)
Method of measurement
5D itch questionnaire
Secondary outcomes
1
Description
Quality of life score in DLQI questionnaire
Timepoint
Before the start of the intervention (the beginning of the study) and two months later (the end of the study)
Method of measurement
DLQI quality of life questionnaire
Intervention groups
1
Description
first intervention group: the patients in this group are given 2 grams of Fumaria parviflora L. in the form of 6 capsules of 330 mg as two capsules three times a day and one placebo capsule is given to them at night
Category
Treatment - Drugs
2
Description
second intervention group: patients in this group are given one capsule of 100 mg of gabapentin at night before going to bed, as well as two placebo capsules three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Hosseini Seyed Ali
Street address
Namazi square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
hoseiniseyyedali70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Zand Street.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseini Seyed Ali
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Namazi hospital, Namazi square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
hoseiniseyyedali70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Position
Asisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
hashempur@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseini Seyed Ali
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Namazi hospital, Namazi square, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
hoseiniseyyedali70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
N/A
When the data will become available and for how long
N/A
To whom data/document is available
N/A
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document