A Comparison Between the Effect of Sugar Heal and Metformin on Fasting Blood Sugar (FBS), 2-hours Postprandial Sugar, Low density lipoprotein and Urea in Pre-diabetic Patients.
Comparison of the effectiveness of Sugar Heal and metformin on the parameters of fasting blood sugar, glucose tolerance test, low density lipoprotein and blood urea in pre-diabetic patients
Design
In this phase 3 study with two parallel groups,136 patients with pre-diabetic condition will be randomized and quadruple blocks will be divided into intervention and control groups, and in this regard, they will receive the intervention or control drug. This study will be a double-blind trial.
Settings and conduct
This study will be performed in Baqiyatallah Hospital in Tehran and patients and researchers will be unaware of the content of each group's drug .
Participants/Inclusion and exclusion criteria
Patients whose pre-diabetic conditions have been confirmed according to scientific criteria.
Be over 18 years old.
without liver and kidney failure, without pregnancy and lactation, without sensitivity to herbal medicines and not taking other drugs that affect blood sugar
Absence of proliferative or neoplastic retinopathy
Intervention groups
The study has two groups هin which, the intervention group will use Sugarheal 1000mg drug and in the control group patients will take metformin 500mg.
Main outcome variables
In patients participating in this study, the rate of change in fasting glucose, the rate of change in blood urea, the rate of change in body lipids, glucose tolerance test and changes in insulin hormone will be measured.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210914052480N1
Registration date:2022-07-06, 1401/04/15
Registration timing:prospective
Last update:2022-07-06, 1401/04/15
Update count:0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Alireza Soleymanitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 4364
Email address
stu.soleymanitabar@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison Between the Effect of Sugar Heal and Metformin on Fasting Blood Sugar (FBS), 2-hours Postprandial Sugar, Low density lipoprotein and Urea in Pre-diabetic Patients.
Public title
effect of sugarheal in patients with prediabetic situation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with confirmed prediabetic situation
over 18 years old
Exclusion criteria:
patients with Chronic renal failure
patients with Chronic liver failure
patients with active pneumonia
patients with Proliferative or active neoplastic retinopathy
pregnancy or lactation
History of allergy to herbal medicines
Taking other drugs that affect blood sugar
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization would be done with 4 units blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are received in similar packages with only one code written on them. By the end of the study, none of the researchers and patients knew the contents of the drug capsules
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
mollasadra st.
City
tehran
Province
Tehran
Postal code
1435916471
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.019
Health conditions studied
1
Description of health condition studied
pre-diabetic condition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fasting blood glucose change
Timepoint
3 months
Method of measurement
blood test
2
Description
change in serum lipids(LDL, HDL, cholesterol, TG)
Timepoint
3 months
Method of measurement
blood test
3
Description
changes in insulin hormone level
Timepoint
3 months
Method of measurement
blood test
4
Description
changes in blood BUN level
Timepoint
3 months
Method of measurement
blood test
5
Description
changes in GTT test
Timepoint
3 months
Method of measurement
blood test
6
Description
changes in Hb A1c level
Timepoint
3 months
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sugarheal medicinal composition from Samanik company: The amount of extract of each plant in one gram is calculated according to the amount of consumption of each plant per day. Therefore, in each gram of the extract, the weight of Capparis Spinosa extract 170 mg, Rosa canina 225 mg, Securigera securidaca170 mg, Silymarin 65 mg, Urtica dioica 170 mg, Trigonella foenum-graecum 115 mg and Vaccinium arctostaphylos 85 mg will be mixed together. 1000 mg of the extract mixture will be poured into two 500 mg long base capsules. The prepared capsule is packed in a box of 60 pieces. Patients will receive two doses from this medicine with their meals for 3 months and then second checkup will be done.
Category
Treatment - Drugs
2
Description
Control group: This group will receive metformin which is the standard protocol nowadays 500 mg twice a day with their meals for three months. These capsules are exactly as same as the capsules of intervention group. After 3 months the second checkup will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان بقیه الله
Full name of responsible person
محمد هیئت
Street address
mollasadra St. Vanak Tehran
City
تهران
Province
Tehran
Postal code
1435916471
Phone
+98 21 8805 0435
Email
mohamad.heiat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohamad heiat
Street address
baqiyatallah hospital, mollasadra St. Tehran, Iran
City
تهران
Province
Tehran
Postal code
1435916471
Phone
+98 21 8805 0435
Email
mohamad.heiat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Samanik 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad heiat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
mollasadra st. Vanak Tehran
City
تهران
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
mohamad.heiat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad heyat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
mollasadra st. Vanak Tehran
City
تهران
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
mohamad.heiat@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Soleymanitabar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
mollasadra st. Vanak Tehran
City
تهران
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
asoleimanitabar21@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
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
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
Title and more details about the data/document
the data would be sent without any personal information of patients
When the data will become available and for how long
after data gathering
To whom data/document is available
Only people with relevant permissions to use confidential information
Under which criteria data/document could be used
The data can be used for statistical analysis and re-examination
From where data/document is obtainable
mohamad heiat Phone no. +98 936 687 6929
What processes are involved for a request to access data/document
After calling or sending an email, the data will be sent if the applicant is valid