Determining the effect of cyproheptadine drug on appetite, laboratory and anthropometric indicators of chronic kidney patients undergoing hemodialysis
Design
Clinical trial with control group with parallel groups, double-blind, randomized, phase 3 on 124 patients. Available sampling was used for randomization.
Settings and conduct
124 patients from 18 to 80 years of age referring to the hemodialysis department of Shahid Jalil Yasouj Hospital are eligible for selection and after obtaining informed consent, they are randomly assigned to two intervention and control groups. For the intervention group, in addition to routine treatment, cyproheptadine tablets will be administered at a dose of 4 mg daily and the placebo for control group. After three months, laboratory and anthropometric parameters and appetite of the patients will be measured.
Participants/Inclusion and exclusion criteria
log :
Chronic kidney patients undergoing hemodialysis, 18 to 80 years old
Patients who undergo dialysis twice a week with good efficacy.
Willingness of people to participate in the plan
Absence of accompanying disease that causes the patient's anorexia.
Not taking drugs that increase appetite.
Exit:
Migration or death of the patient
Dissatisfaction with the continuation of treatment
In case of other infectious or chronic diseases during the research period
Patients who have undergone organ transplant surgery.
Intervention groups
In addition to routine treatment, intervention group patients will be prescribed cyproheptadine 4 mg daily, and placebo for control group will be prescribed. After three months, the laboratory and anthropometric indicators and appetite of the patients will be measured again
Main outcome variables
Improving the physiological conditions and increasing the quality of life of patients undergoing hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220329054368N2
Registration date:2023-04-17, 1402/01/28
Registration timing:prospective
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Farnaz sadat Javanmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 8671
Email address
farnaz.javanmardi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cyproheptadine on appetite ,laboratory and enteropometric indices in chronic renal failure pateint on hemodialysis
Public title
Investigating the effect of cyproheptadine in chronic kidney patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic kidney patients undergoing dialysis between 18 and 80 years of age, at least three months have passed since the start of dialysis.
Patients who undergo dialysis twice a week with good efficacy.
People's willingness to participate in the project.
Absence of accompanying disease (infection, uncompensated heart failure, malignancy, liver cirrhosis, covid-19) that causes the patient's anorexia.
Not taking drugs such as tricyclic antidepressants and corticosteroids that increase appetite.
Exclusion criteria:
Patient migration or death
Dissatisfaction with the continuation of treatment by the patient.
If other infectious or chronic diseases occur during the research period.
Patients who underwent organ transplant surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a random block method. The size of the blocks is chosen randomly (for example, blocks of 4, 8, and 12) where there is an equal number of each group in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the participant do not know which drug is the main drug and which is the placebo.
Placebo
Used
Assignment
Parallel
Other design features
So far, the effect of cyproheptadine on appetite and laboratory parameters of chronic kidney patients has not been investigated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Yasouj University of Medical Sciences , Shahid Motahari Blvd.,
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
07433337230
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.YUMS.REC.1401.127
Health conditions studied
1
Description of health condition studied
Chronic kidney patients undergoing hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
appetite
Timepoint
Before and three months after the intervention
Method of measurement
NMA questionnaire
2
Description
Anthropometric indicators
Timepoint
Before and three months after the intervention
Method of measurement
Meter
3
Description
Laboratory indicators
Timepoint
Before and three months after the intervention
Method of measurement
cycmax
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of cyproheptadine 4mg daily
Category
Treatment - Drugs
2
Description
Control group: Placebo administration
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil Hospital
Full name of responsible person
Ahmad Mokhtari
Street address
Shahid Jalil Hospital , Qarani Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
07433337004
Phone
+98 74 3333 7001
Email
jalilhospital@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
َAhmad Mokhtari
Street address
Yasouj University of Medical Sciences, Motahari Blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
07433337004
Phone
+98 74 3333 7001
Email
jalilhospital@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 8, Eram Ave
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 8, Eram Ave
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 8, Eram Ave
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Investigating the effect of cyproheptadine on appetite ,laboratory and enteropometric indices in chronic renal failure pateint on hemodialysis
When the data will become available and for how long
After acceptance of the article
To whom data/document is available
researchers
Under which criteria data/document could be used
In order to expand research
From where data/document is obtainable
Email to the responsible person
What processes are involved for a request to access data/document