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| Name | Class |
|---|---|
| Afzalipour Hospital | OTHER |
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The goal of this [Efficacy of a traditional anti-diabetic herbal drug with on glycemic, inflammatory, and oxidative stress parameters] is [investigate the level of HOMA-estimated insulin resistance as the primary outcome before and after 40 days in intervention and placebo groups] in [patients with type 2 diabetes]. The secondary outcomes of this study are the assessment of oxidative stress, inflammation biomarkers, other glycemic indices, hematopoietic status and lipid profile between the two groups before and after the intervention. also The food frequency questionnaire (FFQ) and the physical activity questionnaire (FAQ) are used to evaluate the effect of potential confounding factors. This study has the code of ethics IR.KMU.REC.1402.291 from Kerman University of Medical Sciences and this drug has the number 12/14484 from Iran Food and Drug Administration (IFDA).
All the volunteers (Diabetic men and women with HbA1c more than 6.5 from the age of 20 to 65 years who usually use their standard medicine) who meet the entry criteria were directed to the laboratory and imaging center 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. The sample size in this study is 70 people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOSHIN SHAHD drug | Active Comparator | All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug. |
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| placebo | Placebo Comparator | The placebo with the same appearance as the herbal syrup will be drinking nectar. All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received placebo 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-diabetic herbal drug | Drug | All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug. |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-estimated insulin resistance | To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM | 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| plasma MDA | Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor | 40 days |
| plasma protein carbonyl | Investigating the changes in plasma protein carbonyl level as an oxidative stress factor |
| Measure | Description | Time Frame |
|---|---|---|
| WBC count | Investigating the changes in White blood cell counts as hematopoietic status | 40 days |
| RBC count | Investigating the changes in Red blood cell counts as a hematopoietic status |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerman University of Medical Sciences | Kerman | Iran |
A part of the data such as the information related to the main outcome or the like can be shared. Access to study documentation after results are published and 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 for secondary studies. The request sent will be reviewed by the members of the center. If the members agree, they will be notified.
Access to study documentation after results are published.
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 for secondary studies.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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. they 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.
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Anti-diabetic herbal and placebo syrups with the same color, shape, and box but different codes in two groups A and B are employed. After enrollment, each patient is allocated a code. Patients, researchers, and physicians who collect information in this study, assess outcomes, and analyze data for the study are blinded to the assigned treatment (anti-diabetic herbal or placebo) so that all patients are evaluated using their specific assigned code and treatment groups A or B.
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| 40 days |
| plasma TAC | Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor | 40 days |
| plasma SOD enzyme activity | Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor | 40 days |
| plasma catalase enzyme activity | Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor | 40 days |
| plasma reduced glutathione | Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor | 40 days |
| ROS in PBMCs | Investigating the changes in ROS level in PBMCs as an oxidative stress factor | 40 days |
| FBS | Investigating the changes in fasting blood glucose as a glycemic status | 40 days |
| fasting blood Insulin | Investigating the changes in fasting blood Insulin as a glycemic status | 40 days |
| HbA1c | Investigating the changes in HbA1c level as a glycemic status | 40 days |
| Inflammatory biomarkers | Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels | 40 days |
| 40 days |
| Hemoglobin | Investigating the changes in hemoglobin level as a hematopoietic status | 40 days |
| Hematocrit | Investigating the changes in hematocrit level as a hematopoietic status | 40 days |
| blood MCV | Investigating the changes in amount of MCV level as a hematopoietic status | 40 days |
| blood MCH | Investigating the changes in amount of MCH level as a hematopoietic status | 40 days |
| blood MCHC | Investigating the changes in amount of MCHC level as a hematopoietic status | 40 days |
| serum Urea | Investigating the changes in serum Urea level as a biochemistry factor | 40 days |
| serum Uric acid | Investigating the changes in serum Uric acid level as a biochemistry factor | 40 days |
| serum Creatinine | Investigating the changes in serum Creatinine level as a biochemistry factor | 40 days |
| BUN | Investigating the changes in Blood urea nitrogen level as a biochemistry factor | 40 days |
| Total protein | Investigating the changes in total protein level as a biochemistry factor | 40 days |
| Albumin | Investigating the changes in Albumin level as a biochemistry factor | 40 days |
| ALT | Investigating the changes in Alanine transaminase level as a biochemistry factor | 40 days |
| AST | Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor | 40 days |
| lipid profile | Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels | 40 days |
| D006946 | Hyperinsulinism |