Condition 1: Type 2 diabetes. Condition 2: Type 2 diabetes. Type 2 diabetes mellitus without complications Diabetes mellitus due to underlying condition with unspecified complications
Conditions
Interventions
Intervention 1: Intervention group: A 300 mg oral herbal dandelion capsule, licensed for production by Nik Daroei Shafasaz Amiran pharmaceutical Company, will be administered to volunteers at a dose o
Sponsors
Ghoum University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Type 2 diabetes patients aged 30 to 65 years The patient's hemoglobin A1C level must be between 8 and 10 percent over the past 6 months Body Mass Index (BMI) less than 45 kg/m² at screening time Have not participated in another drug research study in the past 30 days Women of childbearing age who have a negative pregnancy test Women using effective contraception during the study
Exclusion criteria
Exclusion criteria: Patients with chronic liver disease or decompensated liver cirrhosis. Patients with fatty liver who are taking medication Patients who are allergic to plants in the chicory family Patients with biliary or intestinal obstruction. Patients with acute cholecystitis and/or empyema Patients with chronic digestive conditions (e.g., gastritis, IBS) Patients with diabetes and renal insufficiency. Patients with a history of alcohol consumption exceeding 10 g/day for women or 20 g/day for men Patients weighing less than 50 kg Patients with uncontrolled underlying diseases such as blood pressure, etc. Patients taking medications with potential interactions with dandelion herbal capsules, including: lithium, digoxin, corticosteroids such as prednisone, niacin/nicotinic acid, metronidazole, disulfiram, tetracycline and fluoroquinolone antibiotics (such as ciprofloxacin), hypoglycemic drugs, antiplatelet drugs, diuretics, antiacids such as Famotidine and esomeprazole Patients who take the following herbs: cat's paw, chamomile, chaparral, fennel, samiana, Echinacea angustifolia, gorse, grapefruit juice, licorice, oregano, red clover, St. John's wort, wild cherry, and yucca Patients with cardiac disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: Baseline evaluations: Conducted at week -2 and week -1 (two weeks and one week before intervention initiation, respectively). Intervention phase monitoring: Weekly assessments from week 0 (intervention commencement) and 1,2,3,4,5,6,7,8,9,10,11,12 weeks after the start of the intervention. Method of measurement: Dialab Glucose Kit and BT1500 fully automated analyzer.;2 hours post prandial blood sugar. Timepoint: Assessment: Two weeks before the start of the intervention (minus 2), one week before the start of the intervention (minus 1), intervention phase assessment: week 0 (intervention commencement) and 1,2,6,7,8 and12 week after the start of the intervention. Method of measurement: BT1500 fully automated analyzer.;Glycated hemoglobin (HbA1C). Timepoint: Initial: 6 months before intervention entry (minus 6), two weeks before intervention entry (minus 2), intervention phase assessment: 12 week after the start of the intervention. Method of measurement: high-performance liquid chromatography (HPLC) kits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Abolhasani
Ghoum University of Medical Sciences
Outcome results
None listed