## Protocol Section
### Identification Module
**NCT ID:** NCT04930679

**Brief Title:** Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.

**Official Title:** A Phase I, Open-label Safety Evaluation of Andiabet of Traphaco J.S.C on Diabetes Mellitus Type II

#### Organization Study ID Info
**ID:** TNLS/2018-03
#### Organization
**Class:** OTHER
**Full Name:** Centre of Clinical Pharmacology, Hanoi Medical University
### Status Module
#### Completion Date
**Date:** 2019-02-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-02-22

**Type:** ACTUAL

#### Start Date
**Date:** 2018-11-24

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2021-06-18
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-11
**Study First Submit QC Date:** 2021-06-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre of Clinical Pharmacology, Hanoi Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Andiabet

**Label:** Group I

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Andiabet

**Label:** Group II

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group I

- Group II

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

**Name:** Andiabet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Adverse events

**Time Frame:** 28 days

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

**Measure:** Fasting blood glucose

**Time Frame:** 28 days

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hanoi

**Country:** Vietnam

**Facility:** Centre of Clinical Pharmacology, Hanoi Medical University

#### Overall Officials

**Official 1:**

**Affiliation:** Center of Clinical Pharmacology, Hanoi Medical University

**Name:** Dung C Nguyen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-24
