Determination of the effect of herbal medicine ZAX.1400.D.05 on blood sugar control in type 2 diabetic patients
Design
A double-blind clinical trial, two treatment groups and a parallel control group will be performed on 80 patients. For randomization, we will use the method of permutation blocks with a number of 6 blocks using Random allocation software.
Settings and conduct
60 patients with type 2 diabetes are divided into two groups, A and B while observing ethical principles. This study is carried out in the specialist health center of the project partner and Dr. Shariati Hospital in Fasa. In this study, the effects of herbal medicine ZAX.1400.D.05 on blood sugar control will be evaluated. Medicines are classified into two groups, A and B, in the same packaging. The study will be blinded at the level of the outcome assessor, the physician and the statistical analyst of the results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Confirmation of type 2 diabetes according to ADA criteria. Age between 40 and 60 years 3. Both sexes (male and female) 4. Having informed and written consent to participate in the study 5. Non-pregnancy and lactation Lack of sensitivity to food and health Conditions for not entering the study: 1. Disagreement of the doctor in charge of the patient 2. History of any allergies 3. History of heart and kidney diseases 4. Patient dissatisfaction
Intervention groups
Divide patients into two similar groups A and B. The treatment group of capsules containing ZAX.1400.D.05 and the placebo group of capsules containing popcorn flour, every 8 hours. By introducing the patient's plan and justification, written consent is received
Main outcome variables
HBA1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220207053960N1
Registration date:2023-06-12, 1402/03/22
Registration timing:prospective
Last update:2023-06-12, 1402/03/22
Update count:0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Fatemeh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 4189
Email address
f.jafari@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ZAX.1400.D.05 drug on hyperglycemia in type 2 diabetes patients; double blind clinical trial
Public title
Evaluation of the effects of herbal medicine on improve diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of type 2 diabetes according to ADA criteria
Age from 40 to 60 years
Having informed consent to participate in the study
Exclusion criteria:
Pregnancy and lactation
History of allergies to herbal products
Disagreement of the responsible physician of the patient before randomization
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This double-blind clinical trial study includes two treatment and control groups. These two groups include 60 patients (person) in parallel. The trained expert divides the patients into two similar groups based on age group, gender, the severity of the disease and the extent of symptoms (based on the supervision of a specialist doctor); Then he randomly places the patients in groups A and B. For randomization, permutation blocks are used (with the help of Random allocation software).
Blinding (investigator's opinion)
Double blinded
Blinding description
After the patient enters the study, the doctor prescribes A (drug) or B (placebo) based on the randomized form. The doctor's prescription is prescribed in the same packages. Clinical caregivers are unaware of the coding assigned to each patient. The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not know about the codings. The results of the two groups under the headings of groups A and B will be submitted by the researcher to the statistical analyst.
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
2023-05-28, 1402/03/07
Ethics committee reference number
IR.FUMS.REC.1402.023
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
Timepoint
Zero days and 60 days after the start of the intervention
Method of measurement
Spectrophotometry
2
Description
FBS
Timepoint
Zero days and 60 days after the start of the intervention
Method of measurement
Auto analyzer
3
Description
Lipid profile
Timepoint
Zero days and 60 days after the start of the intervention
Method of measurement
Auto analyzer
4
Description
Liver enzymes
Timepoint
Zero days and 60 days after the start of the intervention
Method of measurement
Auto analyzer
5
Description
Kidney indicators
Timepoint
Zero days and 60 days after the start of the intervention
Method of measurement
Auto analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ZAX.1400.D.05 drug combination, in capsule formulation, is taken in three daily doses for 60 days.
Category
Treatment - Drugs
2
Description
Control group: The composition of popcorn corn flour, in the form of capsules, is consumed in three daily doses for 60 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Shariati Hospital in Fasa
Full name of responsible person
Dr. Seyed Amin Kuhpayeh
Street address
Ibn Sina Square, Fasa
City
Fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5335 9507
Fax
+98 71 5331 4021
Email
kouhpayeha@gmail.com
Web page address
http://vh.fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Akbar Farjadfar
Street address
Ibn sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 132 5240
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
Student
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
Fax
+98 71 5335 7091
Email
a.dakhili@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Seyed Amin Kuhpayeh
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
Fax
+98 71 5335 7091
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
Student
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
Fax
+98 71 5335 7091
Email
a.dakhili@fums.ac.ir
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
Part of the information obtained will be available based on changes in the initial consequences.
When the data will become available and for how long
Start of access period 6 months after production and publication 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 information is used.
From where data/document is obtainable
Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University of Medical Sciences and Health Services, Ibn Sina Square, Fasa
What processes are involved for a request to access data/document
1. Contacting the general respondent of the 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 ethical principles. 5. The total duration of the process is 20 days.