The effect of Artemisia plant capsule on anorexia in hemodialysis patients
Design
This is a clinical trial. In this study, there are two groups of control who receive placebo and the intervention group receiving Artemisia. 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 not known.
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, the patients in the intervention group will receive the Artemisia capsule and the placebo control group
Main outcome variables
Treatment of anorexia patients with dialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180610040049N1
Registration date:2019-04-28, 1398/02/08
Registration timing:retrospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
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
2018-10-07, 1397/07/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Artemisia plant capsule on anorexia in hemodialysis patients
Public title
The effect of Artemisia plant capsule on anorexia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The hemodialysis patients with questionnaire score<14
Written and informed satisfaction of patients
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
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
Basig
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.ARAKMU.REC.1397.54
Health conditions studied
1
Description of health condition studied
dialysis patients
ICD-10 code
Y84.1
ICD-10 code description
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.
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" The Artemisia plant capsule is given to the intervention group.
Category
Treatment - Drugs
2
Description
"Control group:" The placebo capsule is given to the control group.
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
University of Medical Sciences, Department of Traditional Medicine, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
Sah.latifi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
University of Medical Sciences, Department of Traditional Medicine, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Sah.latifi@arakmu.ac.ir
Grant name
Traditional and complementary medicine research center
Grant code / Reference number
3082
Is the source of funding the same sponsor organization/entity?
Yes
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Basij
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Sah.latifi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Basij
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Sah.latifi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seied Amirhosein Latifi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Basij
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Sah.latifi@arakmu.ac.ir
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