Efficacy of a traditional anti-diabetic herbal composition on glycemic, inflammatory, and oxidative stress parameters in patients with type 2 diabetes. A double-blind randomized clinical trial study
Efficacy of a traditional anti-diabetic herbal composition on glycemic, inflammatory, and oxidative stress parameters in patients with type 2 diabetes
Design
This study is a double-blind and parallel clinical trial that will be conducted in two groups of 35 people on patients with type 2 diabetes referred to Endocrinologists.
Settings and conduct
Patients with type 2 diabetes referred to endocrinologists in Kerman city will randomly receive herbal syrup or placebo in two groups of 35 people in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 and 65 years, consistent diet and exercise program, having HbA1c more than 6.5 and taking standard medicine except insulin.
Exclusion criteria: CABG surgery, the occurrence of ASC, heart attack and stroke, use of anti-inflammatory drugs such as aspirin, the presence of cancer, pregnancy, smoking and alcohol consumption.
Intervention groups
The intervention group will drink herbal syrup and the control group will drink placebo.
Main outcome variables
HOMA-estimated insulin resistance
General information
Reason for update
Acronym
NOSHIN diabetes
IRCT registration information
IRCT registration number:IRCT20221216056833N2
Registration date:2023-12-29, 1402/10/08
Registration timing:prospective
Last update:2023-12-29, 1402/10/08
Update count:0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Hossein Pourghadamyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5829
Email address
ghadamyarih91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2024-11-17, 1403/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a traditional anti-diabetic herbal composition on glycemic, inflammatory, and oxidative stress parameters in patients with type 2 diabetes. A double-blind randomized clinical trial study
Public title
The effect of Noshin Shahd herbal syrup on the glycemic index of patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 65 years
Consistency of diet and exercise program
Body mass index less than 35
HbA1c more than 6.5
Not receiving insulin
The patient should take standard medicine except insulin
Exclusion criteria:
Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year
Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (<1 g/day), and immunosuppressive drugs in the last three months
Presence of cancer, liver and thyroid diseases
pregnancy
Smoking and alcohol consumption
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will be according to the stratified randomization method. Stratification of patients will be performed based on age, gender, and BMI, With the help of Winpepi software (V 11.6).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug or placebo in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the medicine, evaluator, and patient will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
It reminds us that the extract of ten plants effective in the treatment of type 2 diabetes, produced by Noshin Shahd Urmia company, is mass produced with health license number 12.14484 since 2018. This product contains the effective ingredients of common safe medicinal plants that are effective in the treatment of type 2 diabetes. It should be noted that during the 4 years of providing the product to the applicants, while declaring the satisfaction of the customers with the performance of the product, no toxicity or complaints have been reported from the people consuming the extract of ten plants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-29, 1402/08/07
Ethics committee reference number
IR.KMU.REC.1402.291
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11.7
ICD-10 code description
Type 2 diabetes mellitus with multiple complications
Primary outcomes
1
Description
HOMA-estimated insulin resistance
Timepoint
Before the intervention and 40 days after the intervention
Before the intervention and 40 days after the intervention
Method of measurement
CBC
5
Description
Biochemistry factors and lipid profile
Timepoint
Before the intervention and 40 days after the intervention
Method of measurement
Enzymatic assay
Intervention groups
1
Description
Intervention group: All the volunteers who meet the entry criteria were directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received medicine three times a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the six week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests). Return at the end of week 6.
Category
Treatment - Drugs
2
Description
Intervention group: It is worth mentioning that the placebo with the same appearance as the herbal syrup will be drinking nectar. On a weekly basis, the researcher can contact the applicants by phone and while reminding them to use the placebo, they will also be informed about the possible side effects of its use. Biochemical tests will be performed on them before taking the placebo. The volunteers were asked to take the received placebo three times a day after meals. Then, at the end of the sixth week, the patient was asked to visit the clinic for a final evaluation. At this stage, the patient will be asked about possible side effects, and the last stage of sample collection will be done to review all the tests for the next stage of receiving the placebo (biochemical tests).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur Endocrine Research Center
Full name of responsible person
Mohammad hossein Gozashti
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3325 7470
Fax
+98 34 3325 7470
Email
sarashafieipour@yahoo.com
2
Recruitment center
Name of recruitment center
Erfan Salamat Diabetic Support Association of Kerman Province
Full name of responsible person
Ali asghar Abbasi
Street address
Alley 12, Jahad Blvd, Kerman, IRAN
City
Kerman
Province
Kerman
Postal code
7619738379
Phone
+98 34 3244 5853
Email
info@diabeterfan.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Pourghadamyari
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Fax
+98 34 3132 5830
Email
ghadamyarih91@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
30
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
Kerman University of Medical Sciences
Full name of responsible person
Faegheh Bahri
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3325 7448
Email
faegheh.bahri9797@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Pourghadamyari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Kerman University of Medical Sciences, Medical University Campus,Haft-Bagh Highway, Kerman, Iran
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
Yes - There is 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
Not applicable
Title and more details about the data/document
A part of the data such as the information related to the main outcome or the like can be shared.
When the data will become available and for how long
Access to study documentation after results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them.
Under which criteria data/document could be used
For secondary studies
From where data/document is obtainable
The applicant can go to the herbal and traditional medicine research center or submit his request by phone, then after checking by the group members, the documents will be sent to the individual.
Address of the Herbal and Traditional Medicines Research Center: Kerman, Haft Bagh Alavi Blvd., Pardizeh University of Medical Sciences Complex, Nursing Faculty, third floor of the Herbal and Traditional Medicines Research Center
Phone: 31325318
Fax: 31325318
Email: khtmr.center@kmu.ac.ir
The name of the sampler: Ms. Faegheh Bahri
Phone: 09361261331
Email: faegheh.bari9797@gmail.com
What processes are involved for a request to access data/document
The request sent will be reviewed by the members of the center. If the members agree, they will be notified. The applicant can go to the Herbal and Traditional Medicines Research Center and submit his request to receive the documents, then if the respondents agree with the communication method mentioned in the previous section, the published documents will be available to the patients. Put. In addition, before the start of the work, the number and email of the sampler are given to the patients, and the patients receive information about their tests from the sampler. It should be noted that the sampler in this project is in contact with the patients during the entire follow-up period. In addition, the data and documents related to this plan will be available to patients after the official release of the information, and before the release, only the information related to the patients' tests will be available to them.