Diet-control diabetes and prediabetes patients in diet-control diabetes, prediabetes patients, DC capsule Vencure
Conditions
Interventions
DC capsule Vencure Brand is supplied as gray cap hard gelatin capsules, containing 450 mg of the herbal powder mixture,Placebo capsules of identical shape and size contain the same excipients without
DC Capsule Vencure,Placebo
Sponsors
Siriraj Institute of Clinical Research (SICRES)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs and blood chemistry Day 4,8,15 and 30 Change in vitals signs and blood chemistry | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactTullaya Sitasuwan
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed