Kerman Medical University
Faegheh Bahri
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).
Diabetes Mellitus, Type 2
Insulin Resistance
anti-diabetic herbal drug
PHASE4
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 70 participants |
| Masking : | TRIPLE |
| Masking Description : | 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. |
| Primary Purpose : | TREATMENT |
| Official Title : | Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes |
| Actual Study Start Date : | 2025-03-14 |
| Estimated Primary Completion Date : | 2025-04-16 |
| Estimated Study Completion Date : | 2025-07-16 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 20 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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Kerman University of Medical Sciences
Kerman, Iran, Islamic Republic of,