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Comparison of Fumaria parviflora L. with placebo on treatment of refractive uremic pruritus of hemodialysis patients

Protocol summary

Summary
The main purpose of this study is to evaluate the effect of Fumaria Parviflora (FP) on treatment of uremic pruritus of hemodialysis patients. Design: a randomized double- blind placebo-controlled clinical trial. In this study 70 hemodialysis patients (older than 18 years old) with uremic pruritus more than 6 weeks and at least a course of antipruritic therapy without proper response will enroll. After proper informing patients and taking testimonial the patients will be divided in two groups randomly. One group will receive FP (2 capsules three times a day before mealtime for 8 weeks) and one group will receive placebo (2 capsules three times a day before mealtime for 8 weeks). pruritus severity will be assessed by VAS system and DUO questionnaire before and after treatment course and each week during the treatment course. PTH و Hb , BUN , Creatinin, Albumin, ALT, AST, ca, P, PTH, hsCRP, IFN gama , IL4 will be measured before and after treatment course too. Finally two groups will be compared according to changes in their scores of pruritus and the levels of IL4, hsCRP and IFN-gama .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080110410N2
Registration date: 2015-09-18, 1394/06/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-18, 1394/06/27
Registrant information
Name
Rahimeh Akrami
Name of organization / entity
Shiraz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7589
Email address
akrami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-26, 1394/07/04
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of Fumaria parviflora L. with placebo on treatment of refractive uremic pruritus of hemodialysis patients
Public title
Evaluation the effect of Fumaria Parviflora on treatment of hemodialysis patients pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemodialysis patients older than18 years old with itching more than 6 weeks; VAS score equal or more than 4; patients with hemodialysis twice or three times a week; patients should took at least a course of antipruritic treatment with no proper response. Exclusion criteria: liver disease; respiratory disease; kt/V less than 1.2; convulsion history; any dermatologic disease that induce itching; hemolytic disease; malignancies; cholestasis; hepatitis B or C infection; presence of anemia with hemoglubin less than 10 .
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will done according balance blocked randomization with four groups in each block.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.SUMS.REC.1394.63

Health conditions studied

1

Description of health condition studied
uremic pruritus
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Duo score
Timepoint
before and after intervention and weekly during intervention period
Method of measurement
by questionnair and calculating score

2

Description
visual analogue scale
Timepoint
before and after intervention and weekly during intervention period
Method of measurement
visual analogue scale ruler

Secondary outcomes

1

Description
Interleukin4
Timepoint
Before and after intervention
Method of measurement
with Interleukin4 ELISA kit

2

Description
Interferon gama
Timepoint
Before and after intervention
Method of measurement
with Interferon gama ELISA Kit

3

Description
hsCRP
Timepoint
Before and after intervention
Method of measurement
with hsCRP ELISA kit

Intervention groups

1

Description
Intervention group: Fumaria Parviflora capsule produced by Shiraz School of Pharmacy, administer two capsules before breakfast, lunch and dinner (300 mg Fmaria Parviflora powder in each capsule) for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule produced by Shiraz School of Pharmacy, administer two capsules before breakfast, lunch and dinner for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Haj Ebrahimi dialysis center
Full name of responsible person
Mr. Rasti
Street address
Sadra city
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahimeh Akrami
Position
M.D./PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3234 7966
Fax
Email
akrami@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Jamshid Roozbeh
Position
Faculty member
Other areas of specialty/work
Street address
Zand St.
City
Shiraz
Postal code
Phone
+98 71 3230 5411
Fax
Email
roozbehj@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical scineces
Full name of responsible person
Rahimeh Akrami
Position
PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
Iranian Traditional Medicine College, Medicine Faculty, Imam Hossein Square, Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
akrami@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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