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The effect of Acupuncture ,as a complementary medicine,in controlling pruritus in hemodialysis patients

Protocol summary

Summary
In this study, a randomized clinical trial, samples are selected among dialysis patients in hospitals affiliated to Mashhad University of Medical Sciences.They are older than 18 and younger than 65 years old with pruritus for more than three months despite routine treatment .These patient are under dialysis for at least 6 months, Visual Analogue Scale questionnaire Score more than 4 and are able to answer the questions.After completing the questionnaires by the investigator and consent form by patient, dermatologist does skin punch biopsy in the dorsal surface of the hand and prescribes Gabapentin(200-300 mg daily ) for every patient and refers them to acupuncture clinic . Patients were randomly located in one of the 2 groups by acupuncturist. Intervention group receive acupuncture treatment by needling in the SP10, st36, LI4, LV3, sp6 ,2 times a week, for 6 weeks .control group receive sham acupuncture treatment by needling at 1 cm outside the corresponding acupuncture point with similar duration and frequency. After the last session of intervention, patient are referred to dermatology clinic and biopsy on the same condition is prepared and will be sent pathology lab to compare the mast cell infiltration with first biopsy. Before and after treatment, VAS and quality of life questionnaire will be completed by investigator and the mast cell infiltration will be compare by pathologist in both groups then data will be analyzed

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062720282N2
Registration date: 2017-03-28, 1396/01/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Shapour Badiee Aval
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 6829
Email address
badieeash@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-30, 1396/01/10
Expected recruitment end date
2017-05-15, 1396/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acupuncture ,as a complementary medicine,in controlling pruritus in hemodialysis patients
Public title
The Effect of Acupuncture on hemodialysis pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Main Inclusion criteria are:hemodialysis patients; older than 18 years and less than 65 years old; Itching for more than 3 months despite recieving conventional therapy ;VAS scale score greater than 4;Under Hemodialysis at least 6 months ;Be able to answer the questions. Main Exclusion criteria are: Age less than 65 years or more than 18 years; history of bleeding or coagulation disorders;any history of skin disease,psychiatric disease,cancer,liver disease.;.No willing to continue acupuncture treatment during study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Daneshgah 16
City
Mashhad
Postal code
Approval date
2015-07-22, 1394/04/31
Ethics committee reference number
IR.MUMS.FM.REC.1394.223

Health conditions studied

1

Description of health condition studied
Renal failure under Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
pruritus
Timepoint
before and after intervention
Method of measurement
VAS questionnaire

Secondary outcomes

1

Description
Mast cell infiltration
Timepoint
Before and after intervention
Method of measurement
The number of mast cells per microscopic magnification 40 after Giemsa stain

2

Description
Quality of life
Timepoint
Before and after
Method of measurement
Quality life questionnaire

Intervention groups

1

Description
Control Group: Based on inclusion and exclusion criteria,patients are selected.They fill consent and questionnaires forms then dermatologist does skin punch biopsy in the dorsal surface of the hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist through the draw of the parcel.Control group receive acupuncture by needling at 1 centimeter outside certain acupuncture point similar to intervention group, by expert, 2 times a week, for 6 weeks. After the last session of acupuncture, patients fill questionnaires again and are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy.
Category
Treatment - Other

2

Description
Intervention group: Based on inclusion and exclusion criteria,patients are selected.They fill consent and questionnaires forms then dermatologist does skin punch biopsy in the dorsal surface of the hand and prescribes Gabapentin(200-300 mg daily ) for Every patient and refers them to acupuncture clinic . Patients are located randomly in one of the 2 groups by acupuncturist through the draw of the parcel. Intervention group receive acupuncture treatment by needling in the SP10, ST36, LI4, LV3, SP6 by experts 2 times a week, for 6 weeks .After the last session of acupuncture, patients fill questionnaires again and are referred to dermatology clinic.Biopsy on the same condition is prepared and sent to pathology lab to compare the mast cell infiltration with first biopsy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis Department of Hospitals affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Shapour Badiee Aval
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Daneshgah Street,Daneshgah 16,Central Building of University,Ghoreshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shapour Badiee Aval
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Persian and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3768 8519
Fax
Email
Badieeash@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ShapourBadiee Aval
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Persian and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3768 8519
Fax
Email
Badieeash@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shapour Badiee Aval
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshgah 16
City
Mashhad
Postal code
Phone
+98 51 3768 8519
Fax
Email
Badieeash@mums.ac.ir
Web page address

Sharing plan

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