Diabetes Mellitus, Type 2
Conditions
Brief summary
This phase I clinical trial is used to evaluate the safety of Andiabet, a herbal-derived medicinal product that assists in the treatment of type 2 Diabetes (T2D). Thereby, determine efficacy of the drug on stabilizing blood glucose in T2D patients.
Detailed description
This is a 28-day phase I, open-label clinical trial to evaluate safety of Andiabet on . The general purpose is the evaluate safety via adverse events and tolerability of Andiabet on T2D patients, and evaluate effect of Andiabet on clinical and laboratory parameters. The study conducted on volunteering T2D patients, whose HbA1c level is =\< 7.5% and are not pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. The main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which evaluated based on adverse events. Ensuring quality of the data: Sponsor and CRO are supervisors. Supervision will be conducted periodically, ensuring the compliance with the research proposal, following GCP. Hanoi Medical University-Clinical center of Pharmacology is responsible for managing the data. Completed CFR are sent to the Center of Clinical Pharmacology, entered by Microsoft Excel and analysed using SPSS 16.0 Before analysing, these data will be checked randomly, avoiding errors in data entry.
Interventions
DRUGAndiabet
Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole
Sponsors
Centre of Clinical Pharmacology, Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet ALL the following criteria: * Type 2 Diabetes (T2D) patients with HbA1c lower than or equal to 7.5% * BMI range: 18-40 kg/m2 * Diagnosed with T2D or currently treating T2D (prescribed by physicians) with one or more of the following drugs: Metformin, Sulfonyl urea, dipeptidyl peptidase-4 inhibitors, or a-glucosidase inhibitors * Be able to stop using T2D drugs in 4 weeks, while maintaining diets and exercising routine. * Willing to take part in the study.
Exclusion criteria
Participants that have ONE of the following: * Diagnosed with Type 1 Diabetes. * History of complications due to Diabetes Mellitus. * History of cardiovascular diseases: hypertension, heart failure, Unstable agina, stroke or transient ischemic attack, myocardial infarction, arrhythmias, coronary artery interventions. * History of drugs, alcohol addiction. * Uncontrolled high blood pressure * Pre-study screening blood test with abnormal results in total blood compositions, urea, AST, ALT, creatinine, albumin, total bilirubin, total urine analysis. * Test positive for HIV or HbsAg * Abnormal ECG results that are clinically significant. * History of hypersensitivity to any of the ingredients in the testing product. * Female participants that are pregnant or having pregnancy intention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 28 days | 2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product. |
| Fasting blood glucose | 28 days | Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups |
Countries
Vietnam
Outcome results
None listed