Explanation of chronic renal failure and its complications according to Iranian Traditional Medicine and the effect of plant Heilichrysum pseudoplicatum capsule on anorexia and pruritus in hemodialysis patients
The effect of Heilichrysum pseudoplicatum capsule on anorexia and pruritus in patients undergoing hemodialysis
Design
This is a clinical trial. In this study, there are two groups of control ( who receive placebo ) and the intervention group (receiving Heilichrysum pseudoplicatum capsule). The number of people in each group is thirty-five. The study is triple blind: participants, therapeutic staff, and statistical analyst of data and drugs are blinded.
Settings and conduct
This study is done in a supportive center for supportive dialysis in Arak. This study was carried out by a researcher and three-blind blind medical personnel.
Participants/Inclusion and exclusion criteria
The hemodialysis patients with questionnaire score<14 written and informed satisfaction of patients
Intervention groups
Dialysis patients who have the criteria for entering the study are randomly divided into two groups then,Then for 6 weeks the patients in the intervention group will receive the Heilichrysum pseudoplicatum capsule and the control group will receive placebo.
Main outcome variables
Anorexia; pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040049N2
Registration date:2020-03-24, 1399/01/05
Registration timing:registered_while_recruiting
Last update:2020-03-24, 1399/01/05
Update count:0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Amirhosein Latifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3601
Email address
Sah.latifi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanation of chronic renal failure and its complications according to Iranian Traditional Medicine and the effect of plant Heilichrysum pseudoplicatum capsule on anorexia and pruritus in hemodialysis patients
Public title
Effect of plant Heilichrysum pseudoplicatum capsule on anorexia and pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be on hemodialysis treatment for at least three months
Anorexia questionnaire score less than 14
Exclusion criteria:
Patient's willingness to use other therapies
Diabetic patients
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method with 4, 6 and 8 block sizes will be used to assign people to the two groups. Concealment will also be observed by using this method. In this way, each individual is assigned a unique code and is attached to drug packages that will help the blind process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind study , patient and therapeutic personnel and data analyst do not have any type of data and medications. The drugs are encoded and placed on the patient and medical personnel.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-03-08, 1398/12/18
Ethics committee reference number
IR.ARAKMU.REC.1397.54
Health conditions studied
1
Description of health condition studied
Dialysis patients
ICD-10 code
T81.502
ICD-10 code description
Unspecified complication of foreign body accidentally left in body following kidney dialysis
Primary outcomes
1
Description
Appetite
Timepoint
One day before the intervention and one day after the intervention is measured
Method of measurement
Appetite level with SNAQ questionnaire
2
Description
Pruritus rate
Timepoint
One day before the intervention and one day after the intervention is measured
Method of measurement
Pruritus severity with Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the Heilichrysum pseudoplicatum plant capsule is given to the intervention group. Helichrysum is a family of wormwood. The total extract of this plant is used. The dose is 250 mg / kg. For 6 weeks, take one capsule after dinner. These capsules are manufactured by Barij Essence and Pharmacy Department of Shahid Beheshti University.
Category
Treatment - Drugs
2
Description
Control group: the placebo capsule is given to the control group. Placebo capsules have the same size and shape as the drug.And their contents contain corn starch.These capsules are manufactured by Barij Essence and Pharmacy Department of Shahid Beheshti University.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The Half-State Center for Supportive Dialysis in Arak(Hami)
Full name of responsible person
Seied Amirhosein Latifi
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
seiedalatifi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
seiedalatifi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD