Clinical trial NCT06205030: Efficacy of NOSHINtrial in Diabetic Patients
Official title: Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Insulin Resistance
Keywords: Type 2
Diabetes mellitus
Insulin
Lead sponsor: Kerman Medical University
Sponsor class: OTHER
Collaborators: name: Afzalipour Hospital
First posted: 2024-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 20 and 65 years
2. HbA1c more than 6.5
3. Consistency of diet and exercise program
4. Body mass index less than 35
5. Not receiving insulin
6. The patient should take standard medicine except insulin

Exclusion Criteria:

1. Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year.
2. 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.
3. Presence of cancer, liver and thyroid diseases.
4. pregnancy
5. Smoking and alcohol consumption

Primary outcomes:
measure: HOMA-estimated insulin resistance
timeFrame: 40 days
Secondary outcomes:
measure: plasma MDA
timeFrame: 40 days
measure: plasma protein carbonyl
timeFrame: 40 days
measure: plasma TAC
timeFrame: 40 days
measure: plasma SOD enzyme activity
timeFrame: 40 days
measure: plasma catalase enzyme activity
timeFrame: 40 days
measure: plasma reduced glutathione
timeFrame: 40 days
measure: ROS in PBMCs
timeFrame: 40 days
measure: FBS
timeFrame: 40 days
measure: fasting blood Insulin
timeFrame: 40 days
measure: HbA1c
timeFrame: 40 days
measure: Inflammatory biomarkers
timeFrame: 40 days
Other outcomes:
measure: WBC count
timeFrame: 40 days
measure: RBC count
timeFrame: 40 days
measure: Hemoglobin
timeFrame: 40 days
measure: Hematocrit
timeFrame: 40 days
measure: blood MCV
timeFrame: 40 days
measure: blood MCH
timeFrame: 40 days
measure: blood MCHC
timeFrame: 40 days
measure: serum Urea
timeFrame: 40 days
measure: serum Uric acid
timeFrame: 40 days
measure: serum Creatinine
timeFrame: 40 days
measure: BUN
timeFrame: 40 days
measure: Total protein
timeFrame: 40 days
measure: Albumin
timeFrame: 40 days
measure: ALT
timeFrame: 40 days
measure: AST
timeFrame: 40 days
measure: lipid profile
timeFrame: 40 days
Locations:
city: Kerman
country: Iran, Islamic Republic of
facility: Kerman University of Medical Sciences
Study officials:
References: