Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.

NCT04930679 | Completed Phase 1

• 1 other identifier: TNLS/2018-03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Adverse events

  2 AEs recorded, there were changes in biochemical indices. However, these AEs are considered mild and unrelated to the investigated product.

  28 days

• Fasting blood glucose

  Group II is reported to have lower blood glucose compared to group I. However, the difference is efficacy is not clear between 2 groups

  28 days

Study Arms (2)

Group I

EXPERIMENTAL

1 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days

Drug: Andiabet

Group II

EXPERIMENTAL

2 capsule of Andiabet x 3 times/ day . Taken 30 minutes before meals in 28 days

Drug: Andiabet

Interventions

Andiabet DRUG

Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University: lead

Study Sites (1)

Centre of Clinical Pharmacology, Hanoi Medical University

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dung C Nguyen, MD

  Center of Clinical Pharmacology, Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 diabetes type 2 patients are recruited, in which 14 took part in the study, randomly divided into 2 arms.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: November 24, 2018
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)