]>
IRCT20221216056833N2 IRCT 2023-12-29 Kerman University of Medical Sciences The effect of Noshin Shahd herbal syrup on the glycemic index of patients with type 2 diabetes NOSHIN diabetes 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 2024-04-15 anticipated 70 Complete https://irct.ir/trial/74269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. 2-3 type 2 diabetes. Intervention 1: 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. Intervention 2: 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). Yes - There is a plan to make this available What will be shared: A part of the data such as the information related to the main outcome or the like can be shared. When: Access to study documentation after results are published To whom: 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. Conditions: For secondary studies Where to obtain: 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 How to obtain: 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. Comments: There is no further information.
public Faegheh Bahri
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 faegheh.bahri9797@gmail.com Kerman University of Medical Sciences scientific Hossein Pourghadamyari
Kerman University of Medical Sciences, Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7448 ghadamyarih91@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 20 years 65 years Both 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 E11.7 Type 2 diabetes mellitus with multiple complications Treatment - Drugs Placebo 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. 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). HOMA-estimated insulin resistance. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: fasting insulin (mU/mL) × fasting glucose (mg/dL)/405. Oxidative stress factors. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Spectrophotometry, Elisa kit. Inflammatory biomarkers. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Elisa kit, Turbidimetric assay. Glycemic status. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Biochemistry Autoanalyzer, Column chromatography, Elisa kit. Hematopoietic status. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: CBC. Biochemistry factors and lipid profile. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Enzymatic assay. Kerman University of Medical Sciences Approved 2023-10-29 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)