Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes
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Protocol summary
60 eligible patients with type 2 diabetes and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
60 eligible patients with type 2 diabetes and referred to outpatient Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
60 eligible patients with type 2 diabetes and referred to outpatient Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
بیمار مبتلا به دیابت تیپ 2 واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران برای دریافت کپسول 300 میلیگرمی عصاره برگ توت دو بار در روز (گروه مداخله)، یا پلاسبو (گروه کنترل) تقسیم خواهند شد.
نمونه خون ناشتا در ابتدای مطالعه و 12هفته بعد از مداخله از بیماران گرفته خواهد شد. سپس متغیر های گلوکز پلاسمایی ناشتا، انسولین سرمی، HOMA-IR، پروفایل لیپیدی، CRP ،QUICKI NO، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون توتال پلاسما،MDA، هموگلوبین A1C و آنزیمهای ALT و AST در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
بیمار مبتلا به دیابت تیپ 2 واجد شرایط و ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران برای دریافت کپسول 300 میلیگرمی عصاره برگ توت دو بار در روز (گروه مداخله)، یا پلاسبو (گروه کنترل) تقسیم خواهند شد.
نمونه خون ناشتا در ابتدای مطالعه و 12هفته بعد از مداخله از بیماران گرفته خواهد شد. سپس متغیر های گلوکز پلاسمایی ناشتا، انسولین سرمی، HOMA-IR، پروفایل لیپیدی، CRP ،QUICKI NO، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون توتال پلاسما،MDA، هموگلوبین A1C و آنزیمهای ALT و AST در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
بیمار مبتلا به دیابت تیپ 2 واجد شرایط و ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. بیماران برای دریافت کپسول 300 میلیگرمی عصاره برگ توت دو بار در روز (گروه مداخله)، یا پلاسبو (گروه کنترل) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12هفته بعد از مداخله از بیماران گرفته خواهد شد. سپس متغیر های گلوکز پلاسمایی ناشتا، انسولین سرمی، HOMA-IR، پروفایل لیپیدی، CRP ،QUICKI NO، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون توتال پلاسما،MDA، هموگلوبین A1C و آنزیمهای ALT و AST در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
Inclusion criteria: Patients with type 2 diabetes mellitus; aged 35-70 years.
Exclusion criteria:Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
Inclusion criteria: Patients with type 2 diabetes mellitus; aged 35-70 years. Exclusion criteria:Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
مصرف عصاره توت در سه ماه گذشته؛ تغییر در داروهای کاهش دهنده گلوکز در طول مطالعه؛
مصرف داروهای ضد انعقاد؛ بارداری یا شیردهی؛ بدخیمی ها؛ بیماری های مزمن کبدی.
معیار ورود: بیماران مبتلا به دیابت نوع 2؛ سن 35 تا 70 سال.
معیار خروج: مصرف عصاره توت در سه ماه گذشته؛ تغییر در داروهای کاهش دهنده گلوکز در طول مطالعه؛
مصرف داروهای ضد انعقاد؛ بارداری یا شیردهی؛ بدخیمی ها؛ بیماری های مزمن کبدی.
معیار ورود: بیماران مبتلا به دیابت نوع 2؛ سن 35 تا 70 سال. معیار خروج: مصرف عصاره توت در سه ماه گذشته؛ تغییر در داروهای کاهش دهنده گلوکز در طول مطالعه؛ مصرف داروهای ضد انعقاد؛ بارداری یا شیردهی؛ بدخیمی ها؛ بیماری های مزمن کبدی.
General information
N/A
3
na3
2017-05-22, 1396/03/01
2017-01-22, 1395/11/03
2017-0501-22 00:00:00
Due to alterations appeared during the trial.
The updating process was done before publishing the paper to correct the registration information.
DueThe updating process was done before publishing the paper to alterations appeared duringcorrect the trialregistration information.
به علت تغییرات ایجاد شده در حین مطالعه.
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی قبل از انتشار مقاله به علت تغییرات ایجاد شده در حین مطالعهمنظور تصحیح اطلاعات ثبت انجام گرفت.
T2DM patients with FPG of more than 126 mg/dL and less than 200 mg/dL.
Patients with type 2 diabetes mellitus
Aged 35–70 years
T2DM patientsPatients with FPG of more than 126 mg/dL and less than 200 mg/dL.type 2 diabetes mellitus Aged 35–70 years
بیماران T2DM با FPG بیش از 126 میلی گرم در دسی لیتر و کمتر از 200 میلی گرم در دسی لیتر.
بیماران مبتلا به دیابت نوع 2
سن 35 تا 70 سال
بیماران T2DM با FPG بیش از 126 میلی گرم در دسی لیتر و کمتر از 200 میلی گرم در دسی لیتر.مبتلا به دیابت نوع 2 سن 35 تا 70 سال
Mulberry extract intake in the last three months.
Changing in glucose-lowering medications.
Taking anticoagulants during the study.
Pregnancy or lactating.
Malignancies.
Chronic hepatic diseases.
Mulberry extract intake in the last three months
Changing in glucose-lowering medications
Taking anticoagulants during the study
Pregnancy or lactating
Malignancies
Chronic hepatic diseases
Mulberry extract intake in the last three months. Changing in glucose-lowering medications. Taking anticoagulants during the study. Pregnancy or lactating. Malignancies. Chronic hepatic diseases.
Health conditions studied
#1
دیابت تیپ 2
دیابت نوع 2
دیابت تیپنوع 2
Primary outcomes
#1
Enzymatic
Calculated with HOMA formula
EnzymaticCalculated with HOMA formula
آنزیمی
محاسبه شده با فرمول HOMA
آنزیمیمحاسبه شده با فرمول HOMA
Secondary outcomes
#1
ELISA
Enzymatic
ELISAEnzymatic
الایزا
آنزیمی
الایزاآنزیمی
#2
ELISA
Calculated with formula
ELISACalculated with formula
الایزا
محاسبه شده با فرمول
الایزامحاسبه شده با فرمول
#3
ELISA
Immunofluorescence
ELISAImmunofluorescence
الایزا
ایمونوفلورسانس
الایزاایمونوفلورسانس
#4
Triglyceride
Triglycerides
TriglycerideTriglycerides
#5
Enzymatic
ELISA
EnzymaticELISA
آنزیمی
الایزا
آنزیمیالایزا
Intervention groups
#1
Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Intervention group:300 mg Morus Alba leaves’s extract capsule, twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 timestwice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
#2
Control group: placebo capsule; 2 times a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Control group: Placebo capsule; twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Control group: placeboPlacebo capsule; 2 timestwice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
گروه کنترل:روزانه دو عدد کپسول پلاسبو؛ ترکیب نشاسته؛ 12 هفته؛ ساخت شرکت باریج اسانس، کاشان، ایران.
گروه کنترل: کپسول پلاسبو؛ دوبار در روز؛ 12 هفته؛ ساخت شرکت باریج اسانس، کاشان، ایران.
گروه کنترل:روزانه دو عدد کپسول پلاسبو؛ ترکیب نشاستهدوبار در روز؛ 12 هفته؛ ساخت شرکت باریج اسانس، کاشان، ایران.
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 31 5544 3022
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Outpatient Naghavi Clinic
Name of recruitment center - Persian: کلینیک سرپایی نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 31 5544 3022
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Outpatient Naghavi Clinic Name of recruitment center - Persian: کلینیک سرپایی نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715973474 Phone: +98 31 5544 3022 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Barij Research Center of Medicinal Herbs
Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریج
Full name of responsible person - English: Miss L.Hejazi
Full name of responsible person - Persian: سرکار خانم لاله حجازی
Street address - English: Kashan
Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 1165936315
Phone: +98 21 4426 7992
Fax:
Email: info@barijessence.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Dr Gholamali Hamidi
Full name of responsible person - Persian: دکتر غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 73474-87159
Phone: +98 31 5575 0575
Fax:
Email: info@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Barij Research CenterKashan University of Medicinal HerbsMedical Sciences Name of organization / entity - Persian: مرکز تحقیقات گیاهان دارویی باریجدانشگاه علوم پزشکی کاشان Full name of responsible person - English: Miss L.HejaziDr Gholamali Hamidi Full name of responsible person - Persian: سرکار خانم لاله حجازیدکتر غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کیلومتر 44 جاده کاشان-مشهد اردهال، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 116593631573474-87159 Phone: +98 21 4426 799231 5575 0575 Fax: Email: info@barijessence.comkaums.ac.ir Web page address:
Private
Public
privatepublic
Industry
Academic
industryacademic
Barij Research Center of Medicinal Herbs
Kashan University of Medical Sciences
Barij Research CenterKashan University of Medicinal HerbsMedical Sciences
مرکز تحقیقات گیاهان دارویی باریج
دانشگاه علوم پزشکی کاشان
مرکز تحقیقات گیاهان دارویی باریجدانشگاه علوم پزشکی کاشان
Protocol summary
Study aim
The aim of this study is to determine the effects of Mulbery alba leave extract on the metabolic profile, inflammatory factors, and biomarkers of oxidative stress and ALT and AST enzymes on patients with TDM2.
Design
A randomized, double-blind, controlled clinical trial on 60 patients. Computer-generated random numbers were utilized for random assignment.
Settings and conduct
60 eligible patients with type 2 diabetes and referred to outpatient Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetes mellitus; aged 35-70 years.
Exclusion criteria:Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.
Intervention groups
The intervention consists of taking mulberry extract supplement (300 mg) twice per a day during 12 weeks, which is prepared by the Pharmaceutical Company of Barij Essence in Kashan, Iran, previously confirmed by the Food and Drug Administration. The placebo capsules contains starch produced by the same company.
Main outcome variables
Fasting plasma glucose; serum insulin; HOMA-IR; lipid profile; QUICKI; CRP; NO; total antioxidant capacity; total plasma glutathione; MDA; hemoglobin A1C
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT2016081312438N21
Registration date:2017-01-12, 1395/10/23
Registration timing:registered_while_recruiting
Last update:2022-04-29, 1401/02/09
Update count:2
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-22, 1395/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes
Public title
Effect of Morus Alba leaves’s extract supplement on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus
Aged 35–70 years
Exclusion criteria:
Mulberry extract intake in the last three months
Changing in glucose-lowering medications
Taking anticoagulants during the study
Pregnancy or lactating
Malignancies
Chronic hepatic diseases
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated random numbers will be utilized for random assignment. Clinic-trained personnel will be performed all participant enrollment, random allocation and group assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.KAUMS.REC.1395.57
Health conditions studied
1
Description of health condition studied
Diabets type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HOMA-IR
Timepoint
Before the beginning of the study and 12 weeks after
Method of measurement
Calculated with HOMA formula
Secondary outcomes
1
Description
Fasting plasma glucose (FPG)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA
3
Description
QUICKI
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Calculated with formula
4
Description
HbA1C
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Immunofluorescence
5
Description
Triglycerides
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
6
Description
Very low density lipoptotein (VLDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
7
Description
Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
8
Description
Low density lipoptotein (LDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
9
Description
High density lipoptotein (HDL)-Cholesterol
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
10
Description
Alanine transaminase (ALT)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
11
Description
Aspartate transaminase (AST)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Enzymatic
12
Description
C reactive protein (CRP)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
ELISA
13
Description
Nitric oxide (NO)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry
14
Description
Total antioxidant capacity (TAC)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry
15
Description
Glutathione (GSH)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry
16
Description
Malondialdehyde (MDA)
Timepoint
Before the beginning of the study and after 12 weeks.
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group:300 mg Morus Alba leaves’s extract capsule, twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule; twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
73474-87159
Phone
+98 31 5575 0575
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Barij Research Center of Medicinal Herbs
Full name of responsible person
Dr.M. Taghizadeh
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 86 4446 5112
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Z.Asemi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Reserch Expert
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Province
Isfehan
Postal code
1165936315
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available