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Protocol summary
Patients with chronic kidney disease, stages 2 and 3, who visited Shahrvand Kidney subspecialty clinic of Sari
Sample size: 60 people
Clinical trial with control group, double-blind, randomized, phase 2 on 60 patients
Randomization: Random Number Table
Patients with chronic kidney disease, stages 2 and 3, who visited Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
Sample size: 60 people
Clinical trial with control group, double-blind, randomized, phase 2 on 60 patients
Randomization: Random Number Table
Patients with chronic kidney disease, stages 2 and 3, who visited Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari Sample size: 60 people Clinical trial with control group, double-blind, randomized, phase 2 on 60 patients Randomization: Random Number Table
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3 مراجعه کننده به کلینیک فوق تخصصی کلیه شهروند ساری
حجم نمونه: 60 نفر
کارآزمایی بالینی دارای گروه کنترل، دو سویه کور ، تصادفی شده، فاز 2 بر روی 60 بیمار
نحوه تصادفی سازی: جدول اعداد تصادفی
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3 مراجعه کننده به کلینیک فوق تخصصی کلیه شهروند و باغبان ساری
حجم نمونه: 60 نفر
کارآزمایی بالینی دارای گروه کنترل، دو سویه کور ، تصادفی شده، فاز 2 بر روی 60 بیمار
نحوه تصادفی سازی: جدول اعداد تصادفی
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3 مراجعه کننده به کلینیک فوق تخصصی کلیه شهروند و باغبان ساری حجم نمونه: 60 نفر کارآزمایی بالینی دارای گروه کنترل، دو سویه کور ، تصادفی شده، فاز 2 بر روی 60 بیمار نحوه تصادفی سازی: جدول اعداد تصادفی
Location: Shahrvand Kidney subspecialty clinic of Sari
For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
Location: Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
Location: Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
محل: کلینیک فوق تخصصی کلیه شهروند ساری
جهت کورسازی، بیمار و پزشک معالج مسئول ارزیابی بیماران و محقق از نوع درمان هر گروه ( دارو یا پلاسبو) اطلاع نخواهند داشت. به این منظور پس از تصادفی سازی و تقسیم بیماران به دو گروه، دارو و پلاسبو توسط کد A یا B از هم جدا شده و برچسبها توسط مشاور آماری زده می شود. به این ترتیب بیمار و پزشک معالج و محقق از نوع درمان مطلع نخواهند بود.
محل: کلینیک فوق تخصصی کلیه شهروند و باغبان ساری
جهت کورسازی، بیمار و پزشک معالج مسئول ارزیابی بیماران و محقق از نوع درمان هر گروه ( دارو یا پلاسبو) اطلاع نخواهند داشت. به این منظور پس از تصادفی سازی و تقسیم بیماران به دو گروه، دارو و پلاسبو توسط کد A یا B از هم جدا شده و برچسبها توسط مشاور آماری زده می شود. به این ترتیب بیمار و پزشک معالج و محقق از نوع درمان مطلع نخواهند بود.
محل: کلینیک فوق تخصصی کلیه شهروند و باغبان ساری جهت کورسازی، بیمار و پزشک معالج مسئول ارزیابی بیماران و محقق از نوع درمان هر گروه ( دارو یا پلاسبو) اطلاع نخواهند داشت. به این منظور پس از تصادفی سازی و تقسیم بیماران به دو گروه، دارو و پلاسبو توسط کد A یا B از هم جدا شده و برچسبها توسط مشاور آماری زده می شود. به این ترتیب بیمار و پزشک معالج و محقق از نوع درمان مطلع نخواهند بود.
Inclusion criteria: Patients with chronic kidney disease stage 2 and 3, Age range 18 to 65 years
Exclusion criteria: clinically unstable, malignancy, Heart Failure, previous diagnosis of primary hyperoxaluria, History of calcium oxalate kidney stone, Known allergy to almond, Liver failure, Pregnancy, Inability to communicate, Polycystic kidney disease, acute infectious disease
Inclusion criteria: Patients with chronic kidney disease stage 2 and 3, Age range 18 to 75 years
Exclusion criteria: clinically unstable, malignancy, Heart Failure, previous diagnosis of primary hyperoxaluria, History of calcium oxalate kidney stone, Known allergy to almond, Liver failure, Pregnancy, Inability to communicate, Polycystic kidney disease, acute infectious disease
Inclusion criteria: Patients with chronic kidney disease stage 2 and 3, Age range 18 to 6575 years Exclusion criteria: clinically unstable, malignancy, Heart Failure, previous diagnosis of primary hyperoxaluria, History of calcium oxalate kidney stone, Known allergy to almond, Liver failure, Pregnancy, Inability to communicate, Polycystic kidney disease, acute infectious disease
معیارهای ورود به مطالعه: بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3، محدوده سنی 18 تا 65 سال
معیارهای عدم ورود به مطالعه: شرایط بالینی ناپایدار، ابتلا به سرطان، نارسایی قلبی، تشخیص قبلی هیپراگزالوری اولیه، سابقه سنگ کلیه اگزالات کلسیم، حساسیت شناخته شده به بادام، نارسایی کبدی، بارداری، عدم توانایی برقراری ارتباط، بیماری کلیه پلی کیستیک و بیماری عفونی حاد
معیارهای ورود به مطالعه: بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3، محدوده سنی 18 تا 75سال
معیارهای عدم ورود به مطالعه: شرایط بالینی ناپایدار، ابتلا به سرطان، نارسایی قلبی، تشخیص قبلی هیپراگزالوری اولیه، سابقه سنگ کلیه اگزالات کلسیم، حساسیت شناخته شده به بادام، نارسایی کبدی، بارداری، عدم توانایی برقراری ارتباط، بیماری کلیه پلی کیستیک و بیماری عفونی حاد
معیارهای ورود به مطالعه: بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3، محدوده سنی 18 تا 65 سال75سال معیارهای عدم ورود به مطالعه: شرایط بالینی ناپایدار، ابتلا به سرطان، نارسایی قلبی، تشخیص قبلی هیپراگزالوری اولیه، سابقه سنگ کلیه اگزالات کلسیم، حساسیت شناخته شده به بادام، نارسایی کبدی، بارداری، عدم توانایی برقراری ارتباط، بیماری کلیه پلی کیستیک و بیماری عفونی حاد
General information
65
75
6575
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56
56
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2021-01-20, 1399/11/01
2021-01-20 00:00:00
empty
2021-12-06, 1400/09/15
2021-12-06 00:00:00
empty
2021-12-06, 1400/09/15
2021-12-06 00:00:00
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Changing age of patients
Completion of sampling
Changing age of patients Completion of sampling
empty
تغییر سن بیماران
اتمام نمونه گیری
تغییر سن بیماران اتمام نمونه گیری
Patients with chronic kidney disease stage 2 and 3
Age range 18 to 65 years
Patients with chronic kidney disease stage 2 and 3
Age range 18 to 75 years
Patients with chronic kidney disease stage 2 and 3 Age range 18 to 6575 years
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3
محدوده سنی 18 تا 65 سال
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3
محدوده سنی 18 تا 75سال
بیماران مبتلا به بیماری مزمن کلیه مرحله 2 و 3 محدوده سنی 18 تا 65 سال75سال
Primary outcomes
#1
Before the intervention, 4 weeks after the start of the intervention, immediately and one month after the intervention
Before and after the intervention
Before the intervention, 4 weeks after the start of the intervention, immediately and one month after the intervention
قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله
قبل و بعد از مداخله
قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله
Secondary outcomes
#1
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#2
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#3
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#4
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#5
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#6
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#7
Four times (before the intervention, 4 weeks after the intervention, immediately and one month after the intervention)
before and after the intervention
Four times (before the intervention, 4 weeksand after the intervention, immediately and one month after the intervention)
چهار نوبت (قبل از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
چهار نوبت (قبل و بعد از مداخله، 4 هفته پس از شروع مداخله، بلافاصله و یک ماه پس از مداخله)
#8
Three times (before the intervention, immediately and one month after the intervention).
before and after the intervention
Three times (before the intervention, immediately and one month after the intervention).
سه نوبت ( قبل از مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
سه نوبت ( قبل و بعد از مداخله، بلافاصله و یک ماه پس از مداخله)
#9
Three times (before the intervention, immediately and one month after the intervention).
before and after the intervention
Three times (before the intervention, immediately and one month after the intervention).
سه نوبت ( قبل از مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
سه نوبت ( قبل و بعد از مداخله، بلافاصله و یک ماه پس از مداخله)
#10
Three times (before the intervention, immediately and one month after the intervention).
before and after the intervention
Three times (before the intervention, immediately and one month after the intervention).
سه نوبت ( قبل از مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
سه نوبت ( قبل و بعد از مداخله، بلافاصله و یک ماه پس از مداخله)
#11
Three times (before the intervention, immediately and one month after the intervention).
before and after the intervention
Three times (before the intervention, immediately and one month after the intervention).
سه نوبت ( قبل از مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
سه نوبت ( قبل و بعد از مداخله، بلافاصله و یک ماه پس از مداخله)
#12
Three times (before the intervention, immediately and one month after the intervention).
before and after the intervention
Three times (before the intervention, immediately and one month after the intervention).
سه نوبت ( قبل از مداخله، بلافاصله و یک ماه پس از مداخله)
قبل و بعد از مداخله
سه نوبت ( قبل و بعد از مداخله، بلافاصله و یک ماه پس از مداخله)
Recruitment centers
#1
Name of recruitment center - English: Shahrvand Kidney Subspecialty Clinic
Name of recruitment center - Persian: کلینیک فوق تخصصی کلیه شهروند
Full name of responsible person - English: Sedighe meghdadi
Full name of responsible person - Persian: صدیقه مقدادی
Street address - English: Keshavarz 44, Keshavarz Blvd
Street address - Persian: بلوار کشاورز، کشاورز 44
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4815733971
Phone: +98 11 3329 1784
Fax: +98 11 3341 2951
Email: sedighe.meghdadi@yahoo.com
Web page address: https://shahrvand.mazums.ac.ir/
Name of recruitment center - English: Shahrvand Kidney Subspecialty Clinic
Name of recruitment center - Persian: کلینیک فوق تخصصی کلیه شهروند
Full name of responsible person - English: Sedighe Meghdadi
Full name of responsible person - Persian: صدیقه مقدادی
Street address - English: Keshavarz 44, Keshavarz Blvd
Street address - Persian: بلوار کشاورز، کشاورز 44
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4815733971
Phone: +98 11 3329 1784
Fax: +98 11 3341 2951
Email: sedighe.meghdadi@yahoo.com
Web page address: https://shahrvand.mazums.ac.ir/
Name of recruitment center - English: Shahrvand Kidney Subspecialty Clinic Name of recruitment center - Persian: کلینیک فوق تخصصی کلیه شهروند Full name of responsible person - English: Sedighe meghdadiMeghdadi Full name of responsible person - Persian: صدیقه مقدادی Street address - English: Keshavarz 44, Keshavarz Blvd Street address - Persian: بلوار کشاورز، کشاورز 44 City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4815733971 Phone: +98 11 3329 1784 Fax: +98 11 3341 2951 Email: sedighe.meghdadi@yahoo.com Web page address: https://shahrvand.mazums.ac.ir/
#2
Name of recruitment center - English: Baghban Special Clinic
Name of recruitment center - Persian: کلینیک ویژه باغبان
Full name of responsible person - English: Sedighe Meghdadi
Full name of responsible person - Persian: صدیقه مقدادی
Street address - English: Khazar Boulevard
Street address - Persian: بلوار خزر
City - English: sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4816895475
Phone: +98 11 3337 4545
Fax:
Email: sedighe.meghdadi@yahoo.com
Web page address: https://tooba.mazums.ac.ir/
Name of recruitment center - English: Baghban Special Clinic Name of recruitment center - Persian: کلینیک ویژه باغبان Full name of responsible person - English: Sedighe Meghdadi Full name of responsible person - Persian: صدیقه مقدادی Street address - English: Khazar Boulevard Street address - Persian: بلوار خزر City - English: sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4816895475 Phone: +98 11 3337 4545 Fax: Email: sedighe.meghdadi@yahoo.com Web page address: https://tooba.mazums.ac.ir/
Protocol summary
Study aim
Evaluation of the effect of sweet almond capsule on function of kidney and quality of life in patients with chronic renal failure
Design
Patients with chronic kidney disease, stages 2 and 3, who visited Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
Sample size: 60 people
Clinical trial with control group, double-blind, randomized, phase 2 on 60 patients
Randomization: Random Number Table
Settings and conduct
Location: Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic kidney disease stage 2 and 3, Age range 18 to 75 years
Exclusion criteria: clinically unstable, malignancy, Heart Failure, previous diagnosis of primary hyperoxaluria, History of calcium oxalate kidney stone, Known allergy to almond, Liver failure, Pregnancy, Inability to communicate, Polycystic kidney disease, acute infectious disease
Intervention groups
Intervention group will receive capsules, containing 350 mg of almond, twice a day. Control group will receive placebo capsules exactly according to the original medication, twice a day. Both groups are treated for 8 weeks.
Main outcome variables
Glomerular filtration rate
Serum creatinine
Blood Urea Nitrogen
24-hour urine protein
Serum Albumin
Serum uric acid
Serum potassium
Blood pressure
Hemoglobin
Serum C-Reactive Protein (CRP)
Lipid profile
Fasting blood sugar
Quality of Life
General information
Reason for update
Changing age of patients
Completion of sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047465N1
Registration date:2020-08-09, 1399/05/19
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:1
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Sedighe Meghdadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 5545
Email address
s.meghdadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
2021-01-20, 1399/11/01
Actual recruitment end date
2021-12-06, 1400/09/15
Trial completion date
2021-12-06, 1400/09/15
Scientific title
Evaluation of the effect of sweet almond capsule on function of kidney and quality of life in patients with chronic renal failure
Public title
The effect of sweet almond on chronic renal failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic kidney disease stage 2 and 3
Age range 18 to 75 years
Exclusion criteria:
Clinically unstable
Malignancy
Heart Failure
Previous diagnosis of primary hyperoxaluria
History of calcium oxalate kidney stone
Known allergy to almond
Liver failure
Pregnancy
Inability to communicate
Polycystic kidney disease
Acute infectious disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a quadruple block randomization method is used. In this method, all permutations obtained from 2 groups are calculated as follows:
1) AABB 2) ABAB 3) ABBA 4) BABA 5) BAAB 6) BBAA
Among them, using random number table, we will select samples in the following order.
The selected permutation:
3, 1, 4, 5, 2, 6, 3, 1, 2, 5, 6, 4, 1, 6, 3
A is the intervention group and B is the control group. The advantage of this method is that the groups are equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
Drug and placebo are similar in appearance, color and smell.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Faculty of Iranian Medicine, next to Baghban Special Clinic, Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
48168-95475
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.MAZUMS.REC.1399.128
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 2
ICD-10 code
N18.2
ICD-10 code description
Chronic kidney disease, stage 2
2
Description of health condition studied
Chronic kidney disease, stage 3
ICD-10 code
N18.3
ICD-10 code description
Chronic kidney disease, stage 3
Primary outcomes
1
Description
Glomerular filtration rate
Timepoint
Before and after the intervention
Method of measurement
Modification of Diet in Renal Disease (MDRD) formula
Secondary outcomes
1
Description
Serum creatinine
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
2
Description
Blood Urea Nitrogen
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
3
Description
24-hour urine protein
Timepoint
before and after the intervention
Method of measurement
24-hour urine evaluation
4
Description
Serum Albumin
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
5
Description
Serum uric acid
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
6
Description
Serum potassium
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
7
Description
Blood pressure
Timepoint
before and after the intervention
Method of measurement
Sphygmomanometer
8
Description
Hemoglobin
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
9
Description
Serum C-Reactive Protein (CRP)
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
10
Description
Lipid profile
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
11
Description
Fasting blood sugar
Timepoint
before and after the intervention
Method of measurement
Laboratory blood test
12
Description
Quality of Life
Timepoint
before and after the intervention
Method of measurement
The Short Form (36) Health Survey (SF-36)
Intervention groups
1
Description
The drug is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Intervention group will receive capsules, containing 350 mg of almond, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks.
Category
Treatment - Drugs
2
Description
The placebo is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Control group will receive placebo capsules exactly according to the original medication, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrvand Kidney Subspecialty Clinic
Full name of responsible person
Sedighe Meghdadi
Street address
Keshavarz 44, Keshavarz Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3329 1784
Fax
+98 11 3341 2951
Email
sedighe.meghdadi@yahoo.com
Web page address
https://shahrvand.mazums.ac.ir/
2
Recruitment center
Name of recruitment center
Baghban Special Clinic
Full name of responsible person
Sedighe Meghdadi
Street address
Khazar Boulevard
City
sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3337 4545
Email
sedighe.meghdadi@yahoo.com
Web page address
https://tooba.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sedighe Meghdadi
Street address
University of the Payambar-e-Azam-17 km of Farahabad Road - Farahabad Square
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3081
Email
sedighe.meghdadi@yahoo.com
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sedighe Meghdadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, next to Baghban Special Clinic, Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 5545
Email
sedighe.meghdadi@yahoo.com
Web page address
https://rc-sonnati.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Yousofpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, next to Baghban Clinic, Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 3117
Email
m.yousofpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sedighe Meghdadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, next to Baghban Special Clinic, Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 5545
Email
sedighe.meghdadi@yahoo.com
Web page address
https://rc-sonnati.mazums.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
Laboratory information
When the data will become available and for how long
Four months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
s.meghdadi@mazums.ac.ir
What processes are involved for a request to access data/document