Placebo-Controlled, Randomized Pilot Study of efficacy and safety of DC Capsule Vencure Brand in diet-control diabetes and prediabetes patients
- Conditions
- Diet-control diabetes and prediabetes patientsin diet-control diabetes, prediabetes patients, DC capsule Vencure
- Registration Number
- TCTR20210721007
- Lead Sponsor
- Siriraj Institute of Clinical Research (SICRES)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 24
1.Males or females aged between 18-65 years.
2.Had at least two test results of FBS>100 mg/dl or HbA1c >5.7% or 2-hr OGTT>140 mg/dl within the last 12 months
3.Willing and able to complete all study procedures, visits, and restrictions and capable of giving written informed consent.
4. Female subject who have negative urine pregnancy test result
5. Female subject who is childbearing potential or
male subject agree to use an acceptable birth control
method from visit 1 to the follow up visit. The
acceptable birth control method is defined as a
barrier method of contraception (including condoms,
intrauterine device and diaphragm with spermicidal
agent) or total abstinence from sexual intercourse
form visit 1 to the follow up visit. Hormonal
contraceptives are not acceptable. Female subject who
is non-childbearing potential: hysterectomy, both
ovaries removed, surgically sterilized or
postmenopausal (For at least 12 consecutive months of
amenorrhea).
1.Had the history of receiving any beta-blocker or thiazide diuretic or more than two concomitant hypertension medications
2.Had the history of receiving two or more lipid lowering agents
3.Has the systolic blood pressure (SBP) >140 mmHg on the screening day
4.Has the diastolic blood pressure (DBP) >90 mmHg on the screening day
5.Has the result of eGFR < 60 ml/min/1.73m2 on the screening day
6.Has the result of Hb <10 g/dl on the screening day
7.Has the result of HbA1c >=8 or FBS > 180 mg/dl or any hyperglycemic symptom(s) on the screening day
8.Has the aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) more than 1.5 times of upper limit of the hospital laboratory reference on the screening day
9.Has the result of total bilirubin > 2.5 mg/dl on the screening day
10.Has the triglyceride more than 500 mg/dl on the screening day
11.Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
12.Received the any medications except antihypertensive drug(s) or lipid lowering agent, or vitamin and mineral supplement(s) within 28 days prior to the first dose of study drug
13.Pregnancy or breast feeding, male partners of pregnant females.
14 The subject received a drug or investigational product from other study within 28 day prior to
receiving the drug in this study.
15.Inability to understand the Protocol or follow its instructions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vital signs and blood chemistry Day 4,8,15 and 30 Change in vitals signs and blood chemistry
- Secondary Outcome Measures
Name Time Method Blood sugar and Insulin level Day 1 (0, 30 60, 90 and 120 min after std meal), Day 4, 8, 15 (0, 30 60, 90 and 120 min after std meal) and Day 30 Effect in FBS, post prandial blood sugar, HbA1C and Insulin level