Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
NCT ID: NCT05760456
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2023-03-15
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DIDALA
DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.
DIDALA hard capsules
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
METFORMIN
Metformin
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks
Interventions
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DIDALA hard capsules
DIDALA is given orally with a dose of 2 capsules, 3 times per day for 12 weeks
Metformin
Metformin 500mg, 1 tablet twice a day, immediately after breakfast and dinner for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011).
* Fasting blood glucose ≤ 10.0 mmol/L.
* No previous treatment with metformin or other antidiabetic drugs.
* Ability and willingness to provide written informed consent and comply with the protocol's requirements.
* Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study.
Exclusion Criteria
* Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health.
* Pregnancy or lactation.
* Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis.
* Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.
18 Years
ALL
No
Sponsors
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Centre of Clinical Pharmacology, Hanoi Medical University
OTHER
Responsible Party
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Locations
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Hanoi Hospital of Traditional Medical
Hanoi, , Vietnam
National Hospital of Traditional Medicine
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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V5.0 08.08.2022
Identifier Type: -
Identifier Source: org_study_id
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