Therapeutic effects of Diacare herbal medicine on blood sugar control in type 2 diabetic patients
Design
A double-blind clinical trial, two treatment groups and a placebo in parallel will be a study on 80 patients. For randomization, we will use the method of permutation blocks with several 6 blocks using Random allocation software.
Settings and conduct
Patients with type 2 diabetes referred to the partner medical centers in the project are divided into A and B groups. The therapeutic effects of Diacare on clinical and laboratory indicators of type 2 diabetes will be evaluated. The study will be blinded at the level of outcome assessor, physician, and statistical analyst. Location: Fasa University of Medical Sciences
Participants/Inclusion and exclusion criteria
inclusion criteria
1. Diagnosis by a doctor 2. Age from 40 to 60 years 3. At least two years of history of type 2 diabetes 4. Having informed and written consent to participate in the study
Criteria for non-entry
1. Patients with side infections 2. Cardiovascular patients 3. Pregnancy and lactation 4. The disagreement of the physician directly responsible for the patient 5. Food and health allergies
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Intervention groups
Divide patients into two similar groups A and B. The treatment group of capsules containing Diacare drug and the placebo group of capsules containing popcorn flour, every 12 hours. By introducing the patient's plan and justification, written consent is received.
Main outcome variables
HBA1C Changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210218050404N6
Registration date:2022-03-10, 1400/12/19
Registration timing:registered_while_recruiting
Last update:2022-03-10, 1400/12/19
Update count:0
Registration date
2022-03-10, 1400/12/19
Registrant information
Name
Amin Dakhili Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 9507
Email address
a.dakhili@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-05, 1400/12/14
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Diacare (Herbal Anti diabetic drug) on hyperglycemia in diabetic patient type2: clinical trial double blind
Public title
The effect of medicinal plants on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the disease by a doctor
Age from 40 to 60 years
At least two years of history of type 2 diabetes
Having informed and written consent to participate in the study
Exclusion criteria:
Patients with lateral infections
Cardiovascular patients
Pregnancy and lactation
Disagreement of the physician directly responsible for the patient
Food and health allergies
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with type 2 diabetes, after diagnosis and confirmation of admission requirements, enter the study with personal consent. For patients, the study code along with the relevant information (medication regimen, age and sex, severity of disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, gender, severity of the disease and symptoms, and randomly divides one group into group A and one group into group B using the patient code numbers. Give. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
after fulfillment of inclusion criteria, the physician will be prescribe A (the drug) or B (placebo) according to the randomized sheet. the prescription will be dispensed in the same package. healthcare givers will be unaware about coding dedicated to every patient. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Ibn Sina square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
IR.FUMS.REC.1394.13
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
HBA1C change
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
spectrophotometer
2
Description
Fasting blood sugar
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
3
Description
Metformin consumption
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
questionnaire
4
Description
lipid profile test
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
5
Description
Liver enzyme Aspartate aminotransferase (SGOT)
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
6
Description
Renal indicator Blood Urea Nitrogen (BUN)
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
7
Description
Renal indicator Creatinine
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
8
Description
Liver enzyme Alkaline Phosphatase (ALP)
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
9
Description
Liver enzyme Alanine aminotransferase (SGPT)
Timepoint
Before the start of the study, 2 and 4 months after starting the drug
Method of measurement
Autoanalyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The drug composition Diacar, based on the active ingredients in plant extracts, is taken in capsule form, in two daily doses, over a period of two months.
Category
Treatment - Drugs
2
Description
Control group: The use of a combination of popcorn flour, in the form of capsules in the form of two daily doses, is consumed over two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Shariati Hospital
Full name of responsible person
Dr. Seyyed Amin Kouhpayeh
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5335 9507
Email
kouhpayeha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Yaser Mansoori
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5335 9507
Email
Fums.mansoori@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
0715335907
Email
amindakhiliardestani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Seyyed Amin Kouhpayeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 9507
Email
kouhpayeha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 9507
Email
amindakhiliardestani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the information obtained will be available based on changes in initial outcomes
When the data will become available and for how long
Start of access period 6 months after production of results
To whom data/document is available
People engaged in research in medical universities of the country
Under which criteria data/document could be used
The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if the information is used
From where data/document is obtainable
Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
What processes are involved for a request to access data/document
1. Contacting the general respondent of study 2. Sending his formal request to the respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process is 20 days.