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Investigating the effect of natural glucoside product on glycemia of patients with type 2 diabetes, lipidemia and fatty liver disease.

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History
# Registration date Revision Id
2 2024-08-18, 1403/05/28 312175
1 2024-08-15, 1403/05/25 311562
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  • Protocol summary

    100 patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant compound daily for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual medicine along with a placebo with the same conditions
    100 patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant composition six times a day for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual drug along with a placebo with the same conditions
    100 نفر از بیماران مبتلا به دیابت تایپ 2 بصورت تصادفی(اعداد زوج و فرد) در دو گروه قرار می گیرند. گروه اول شامل: گروه مورد که داروی معمول را به همراه ترکیب گیاهی گلوکوسید روزانه یک عدد به مدت 3 ماه تحت نظر پزشک معالج دریافت می کنند. گروه دوم: گروه شاهد شامل بیمارانی که داروی معمول را همراه با پلاسبو با همان شرایط دریافت می کنند.
    100 نفر از بیماران مبتلا به دیابت تایپ 2 بصورت تصادفی(اعداد زوج و فرد) در دو گروه قرار می گیرند. گروه اول شامل: گروه مورد که داروی معمول را به همراه ترکیب گیاهی گلوکوسید روزانه شش عدد به مدت 3 ماه تحت نظر پزشک معالج دریافت می کنند. گروه دوم: گروه شاهد شامل بیمارانی که داروی معمول را همراه با پلاسبو با همان شرایط دریافت می کنند.
    Diabetes; Age; sex; BMI; HbA1c; FBS; BS.2h; hyponatremia; Hypokalemia; urea; Serum creatinine; UA; Mtt cytotoxicity assay; Lipid profile; Liver function tests.
    Diabetes; Age; sex; BMI; HbA1c; FBS; BS.2h; urea; Serum creatinine; UA; Mtt cytotoxicity assay; Lipid profile; Liver function tests.
    دیابت سن جنس BMI HbA1c FBS BS.2h سدیم خون پتاسیم خون اوره خون کراتینین سرم UA Mtt بررسی سمیت سلولی بررسی پروفایل لیپیدی بررسی تستهای عملکردی کبدی
    دیابت سن جنس BMI HbA1c FBS BS.2h اوره خون کراتینین سرم UA Mtt بررسی سمیت سلولی بررسی پروفایل لیپیدی بررسی تستهای عملکردی کبدی

  • Primary outcomes

    #1
    Blood sodium
    Blood urea
    سدیم خون
    اوره خون
    Sodium Blood test
    Blood urea test
    #2
    Blood Potassium.
    Serum creatinine
    پتاسیم خون
    کراتینین سرم
    Potassium Blood test
    Blood test
    ازمایش پتاسیم خون
    ازمایش خون
    #3
    Blood urea
    Analyze urine
    اوره خون
    انالیز ادرار
    Blood urea test
    Urinalysis
    ازمایش خون
    ازمایش ادرار
    #4
    Serum creatinine
    Cytotoxicity assay
    کراتینین سرم
    بررسی سمیت سلولی
    Blood test
    Blood Test
    #5
    Analyze urine
    Lipid profile
    انالیز ادرار
    پروفایل لیپیدی
    Urinalysis
    Lipid profile Blood Test.
    ازمایش ادرار
    ازمایش خون
    #6
    Cytotoxicity assay
    Liver function tests.
    بررسی سمیت سلولی
    تستهای عملکردی کبدی
    Blood Test
    Blood Test.
    #7
    Lipid profile
    empty
    پروفایل لیپیدی
    empty
    Before the start of the intervention and 90 days after the start of the drug
    empty
    قبل از شروع مداخله و 90 روز پس از شروع دارو
    empty
    Lipid profile Blood Test.
    empty
    ازمایش خون
    empty
    #8
    Liver function tests.
    empty
    تستهای عملکردی کبدی
    empty
    Before the start of the intervention and 90 days after the start of the drug
    empty
    قبل از شروع مداخله و 90 روز پس از شروع دارو
    empty
    Blood Test.
    empty
    ازمایش خون
    empty

  • Intervention groups

    #1
    Intervention group: They receive the usual medicine along with 500mg glucoside plant compound daily for 3 months under the supervision of a treating physician.
    Intervention group: they will receive the usual medicine along with 500mg glucoside herbal combination six times a day for 3 months under the supervision of a treating physician.
    گروه مداخله: داروی معمول را به همراه ترکیب گیاهی گلوکوسید500mg روزانه یک عدد به مدت 3 ماه تحت نظر پزشک معالج دریافت می کنند
    گروه مداخله: داروی معمول را به همراه ترکیب گیاهی گلوکوسید500mg روزانه شش عدد به مدت 3 ماه تحت نظر پزشک معالج دریافت می کنند

  • Recruitment centers

    #1
    Name of recruitment center - English: Bilal Habashi Social Security Clinic
    Name of recruitment center - Persian: کلینیک تامین اجتماعی بلال حبشی
    Full name of responsible person - English: Seyyed Mohammad Reza Hashemizadeh
    Full name of responsible person - Persian: سید محمدرضا هاشمی زاده
    Street address - English: Resalat Blvd., Bilal Quay, Mashhad Town.
    Street address - Persian: مشهد، کوی بلال، بلوار رسالت، خیابان قائم.
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9185914711
    Phone: +98 51 3762 7910
    Fax:
    Email: dr.hashemizadeh@gmail.com
    Web page address:
    Name of recruitment center - English: Fateq Social Security Clinic
    Name of recruitment center - Persian: درمانگاه تامین اجتماعی فاتق.
    Full name of responsible person - English: Seyyed Mohammad Reza Hashemizadeh
    Full name of responsible person - Persian: سید محمدرضا هاشمی زاده
    Street address - English: Hijab 87; Qasim Abad Street; Mashhad Town.
    Street address - Persian: مشهد، قاسم آباد، حجاب 87
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 8413015
    Phone: +98 51 3615 6000
    Fax:
    Email: Dr.hashemizadeh@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Touraj Zandbaf
    Full name of responsible person - Persian: دکتر تورج زندباف
    Street address - English: No.14 , Emam khomein Ave., Mashhad Town
    Street address - Persian: مشهد، کوچه امام خمینی 14
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9193798666
    Phone: +98 51 3225 0041
    Fax:
    Email: IMRC@mshdiau.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Touraj Zandbaf
    Full name of responsible person - Persian: دکتر تورج زندباف
    Street address - English: No.14 , Emam khomein Ave, Mashhad Town.
    Street address - Persian: مشهد، کوچه امام خمینی 14
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9193798666
    Phone: +98 51 3225 0041
    Fax:
    Email: IMRC@mshdiau.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyyed Mohammad Reza Hashemizadeh
    Full name of responsible person - Persian: سید محمدرضا هاشمی زاده
    Position - English: A doctor specializing in traditional medicine
    Position - Persian: پزشک متخصص طب سنتی
    Latest degree: specialist
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.9, 21 Ibn Sina Ave; Senabad St; Mashhad Town.
    Street address - Persian: خیابان سناباد، ابن سینا21 پلاک9
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9183664555
    Phone: +98 51 3845 3742
    Mobile: +98 915 109 8452
    Fax:
    Email: Dr.hashemizadeh@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyyed Mohammad Reza Hashemizadeh
    Full name of responsible person - Persian: سید محمدرضا هاشمی زاده
    Position - English: General physician
    Position - Persian: پزشک عمومی
    Latest degree: med_doctor
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.9, 21 Ibn Sina Ave; Senabad St; Mashhad Town.
    Street address - Persian: خیابان سناباد، ابن سینا21 پلاک9
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9183664555
    Phone: +98 51 3845 3742
    Mobile: +98 915 109 8452
    Fax:
    Email: Dr.hashemizadeh@gmail.com
    Web page address:

Protocol summary

Study aim
If the clinical and laboratory results are confirmed, the glucoside natural product can be used as a herbal medicine be introduced for the therapeutic use of patients.
Design
A clinical trial with a control group, with cross-over groups, three blind strains, randomized, phase 2 for 100 patients, random numbers of even and odd numbers have been used for randomization.
Settings and conduct
The place of the project is Shahid Faeq Social Security Clinic. Random blinding is based on even and odd numbers. All people except the attending physician are blinded in this plan
Participants/Inclusion and exclusion criteria
Hyperglycemia
Intervention groups
100 patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant composition six times a day for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual drug along with a placebo with the same conditions
Main outcome variables
Diabetes; Age; sex; BMI; HbA1c; FBS; BS.2h; urea; Serum creatinine; UA; Mtt cytotoxicity assay; Lipid profile; Liver function tests.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231030059908N4
Registration date: 2024-08-15, 1403/05/25
Registration timing: registered_while_recruiting

Last update: 2024-08-21, 1403/05/31
Update count: 1
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Fateme Mollazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 4944
Email address
f.mollazade1159@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-11-15, 1403/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of natural glucoside product on glycemia of patients with type 2 diabetes, lipidemia and fatty liver disease.
Public title
Investigating the effect of natural glucoside product on glycemia of patients with type 2 diabetes, lipidemia and fatty liver disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hyperglycemia Hyperlipidemia
Exclusion criteria:
History of allergy to drug compounds
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients with type 2 diabetes are randomly divided into two groups (odd and even numbers). The first group includes: the case group that receives the usual medicine along with the glucoside plant compound daily for 3 months under the supervision of the attending physician. The second group: the control group includes patients who receive the usual medicine along with a placebo with the same conditions. Specific codes will be determined for all patients, and except for the treating physician, the plan implementers will be unaware of it. At the end of the design of the codes, the doctor will provide them to the statistical analyzer and statistical analysis will be done.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Azad University of Medical Sciences
Street address
No14, Emam khomeini Ave, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2024-07-10, 1403/04/20
Ethics committee reference number
IR.IAM.MSHD.REC.1403.25

Health conditions studied

1

Description of health condition studied
Hyperglycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycemia, unspecified

2

Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified

Primary outcomes

1

Description
Age
Timepoint
Before the intervention
Method of measurement
Age number

2

Description
Sex
Timepoint
Before intervention
Method of measurement
Ratio

3

Description
BMI
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Numerical formula

4

Description
HbA1c
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test

5

Description
Fasting blood suger
Timepoint
Before the start of the intervention and 90 days after the start of the drug.
Method of measurement
Blood test.

6

Description
Two hours post prandial glucose.
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test

7

Description
Blood urea
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood urea test

8

Description
Serum creatinine
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood test

9

Description
Analyze urine
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Urinalysis

10

Description
Cytotoxicity assay
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood Test

11

Description
Lipid profile
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Lipid profile Blood Test.

12

Description
Liver function tests.
Timepoint
Before the start of the intervention and 90 days after the start of the drug
Method of measurement
Blood Test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: they will receive the usual medicine along with 500mg glucoside herbal combination six times a day for 3 months under the supervision of a treating physician.
Category
Treatment - Drugs

2

Description
Control group: Patients receiving the usual drug plus a placebo for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fateq Social Security Clinic
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Street address
Hijab 87; Qasim Abad Street; Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
8413015
Phone
+98 51 3615 6000
Email
Dr.hashemizadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Touraj Zandbaf
Street address
No.14 , Emam khomein Ave, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 3225 0041
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bo Ali Research Institute of Saleh Daru Novin Mashhad Company.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.9, 21 Ibn Sina Ave; Senabad St; Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183664555
Phone
+98 51 3845 3742
Email
Dr.hashemizadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyed Mohammad Reza Hashemizadeh
Position
A doctor specializing in traditional medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
21 Ibn Sina St., Senabad Street, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9183664555
Phone
+98 915 109 8452
Email
Dr.hashemizadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No. 8, Alaleh Ave, Pirouzi Blvd, Mashhad Town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 5523 4944
Fax
Email
F.mollazade1159@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the information that is useful will be published for the use of others.
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
Researchers and people working in the industry.
Under which criteria data/document could be used
It is allowed to use the results of the study for the benefit of the patients
From where data/document is obtainable
Dr. Hashemizadeh to the following email address: drhashemizadeh@gmail.com
What processes are involved for a request to access data/document
Send request to the mentioned email.
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