The effect of Iranian Traditional Medicine-based diet compared to classical Medicine-based diet on proteinuria in children with nephrotic syndrome. A randomized clinical trial
Primary purpose: evaluation of the effectiveness of classical medicine diet with Iranian medicine approach in comparison with classical medicine diet alone on urinary protein excretion
Design
A clinical trial with the control group, with parallel, randomized groups, on 20 patients.
RAS software was used for randomization.
Settings and conduct
The sampling place is Mofid Children's Hospital. Easy random sampling. The patient and the statistician are blind to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: age 2 to 12 years old; diagnosis of nephrotic syndrome; BMI percentile for ages between 5 and 85; CKD1-2; ability and willingness to cooperate in research projects.
Exclusion criteria: any severe congenital and inherited disease; heart failure; advanced renal failure; hypo and hyperthyroidism; severe inflammatory diseases such as lupus; diabetes
Intervention groups
In the control group, only classical nutrition (accurate calculation of energy and protein, and restriction of sodium and saturated and trans fats) and in the intervention group, in addition to the classical medicine diet, the recommendations of Iranian Traditional Medicine (ITM) will be given. Dietary interventions in ITM for nephrotic syndrome include paste, pomegranate paste, and wheat bran. The diet of the control group is adjusted based on traditional medicine interventions so that there is no difference in terms of energy and macronutrients.
Main outcome variables
Random urine protein; lipid profile; serum Album
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047027N2
Registration date:2021-11-08, 1400/08/17
Registration timing:registered_while_recruiting
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
alireza rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 4020
Email address
a74.rahmani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Iranian Traditional Medicine-based diet compared to classical Medicine-based diet on proteinuria in children with nephrotic syndrome. A randomized clinical trial
Public title
Traditional medicine diet in nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 and 12 years old
Diagnosis of nephrotic syndrome
Body mass index (BMI) 5 to 85th percentile
Chronic kidney disease stage 1-2 (CKD 1-2)
Ability and willingness to collaborate on research projects
Exclusion criteria:
Any severe congenital or inherited diseases
Heart failure
Advanced renal failure
Hypo and hyperthyroidism
Severe inflammatory diseases such as lupus
Diabetes mellitus
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly divided into two groups of 10, using the RAS software, and studied for one month. A statistician will do this process.
Blinding (investigator's opinion)
Single blinded
Blinding description
During the visit for each patient in the control group, a diet based on classical medicine is calculated for them and explained to them along with an attached sheet. In addition to receiving the classical medicine diet, patients in the intervention group also receive Iranian traditional medicine food interventions.
Since patients were visited separately and did not communicate with each other, they would not be aware of the different regimens prescribed by the researcher and would be blind to the intervention.
In addition, the statistician in charge of data analysis does not know the control and intervention group and is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahed University
Street address
Shahed University, in front of the Holy Shrine of Imam Khomeini, The beginning of the Tehran-Qom freeway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2021-09-06, 1400/06/15
Ethics committee reference number
IR.SHAHED.REC.1400.064
Health conditions studied
1
Description of health condition studied
Nephrotic Syndrome
ICD-10 code
N03
ICD-10 code description
A Chronic nephritic syndrome with C3 glomerulonephritis
Primary outcomes
1
Description
Random urine protein
Timepoint
Start of study and end of study (after 4 weeks)
Method of measurement
Urine analysis methods for random urine protein
2
Description
Lipid profiles
Timepoint
Start of study and end of study (after 4 weeks)
Method of measurement
Biochemical methods for lipid profiles
3
Description
Albumin serum
Timepoint
Start of study and end of study (after 4 weeks)
Method of measurement
Biochemical methods for albumin serum
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: quince sauce (1 tablespoon after meals), pomegranate paste (1 tablespoon before meals), and ground barley (Savigh) (1 tablespoon per day)
Category
Treatment - Other
2
Description
Control group: classical medicine diet (accurate calculation of energy and protein, sodium and saturated and trans fats)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Reza Ilkhani
Street address
Mofid Children's Hospital, Shariati St.
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahed University of Medical Sciences
Street address
Shahed University, in front of the Holy Shrine of Imam Khomeini, The beginning of the Tehran-Qom freeway
City
tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 7736 4020
Email
a74.rahmani@gmail.com
Grant name
Shahed University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University, Shams Alley, Vali Asr Street
City
tehran
Province
Tehran
Postal code
1653666741
Phone
+98 21 8877 3521
Email
a74.rahmani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University, Shams Alley, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1653666741
Phone
+98 21 8877 3521
Email
a74.rahmani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raza Ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shahid Beheshti University, Shams Alley, Vali Asr Street
City
tehran
Province
Tehran
Postal code
1653666741
Phone
+98 21 8877 3521
Email
a74.rahmani@gmail.com
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
The protocol of how the work is performed and the results are shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Faculty members of nutrition and traditional medicine
From where data/document is obtainable
Via message to the first author's personal email.
What processes are involved for a request to access data/document
Message to email. Information will be sent if needed.