Efficacy of NOSHINtrial in Diabetic Patients

Официальное название

Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат anti-diabetic herbal 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.

Первичные конечные точки

• HOMA-estimated insulin resistance [Срок оценки: 40 days]

Вторичные конечные точки (11)

• plasma MDA [Срок оценки: 40 days]
• plasma protein carbonyl [Срок оценки: 40 days]
• plasma TAC [Срок оценки: 40 days]
• plasma SOD enzyme activity [Срок оценки: 40 days]
• plasma catalase enzyme activity [Срок оценки: 40 days]
• plasma reduced glutathione [Срок оценки: 40 days]
• ROS in PBMCs [Срок оценки: 40 days]
• FBS [Срок оценки: 40 days]
• fasting blood Insulin [Срок оценки: 40 days]
• HbA1c [Срок оценки: 40 days]
• Inflammatory biomarkers [Срок оценки: 40 days]

Критерии участия

Критерии включения

• Age between 20 and 65 years
• HbA1c more than 6.5
• Consistency of diet and exercise program
• Body mass index less than 35
• Not receiving insulin
• The patient should take standard medicine except insulin

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Иран · 1 центр

• Kerman University of Medical Sciences — Kerman

Идентификаторы

NCT: NCT06205030 · 402000209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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