Pre-diabetes, diabetes mellitus not insulin requiring stage. Nutritional, Metabolic, Endocrine Unspecified diabetes mellitus
Conditions
Interventions
1. Treatment group: PURIAM110 (1:1 mixture of bitter oranges [Fructus Aurantii] and mulberry leaves [Folium Mori]).
2. Control group: placebo.
Both treatment and place
Sponsors
Korea Health Industry Development Institute (KHIDI) (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either sex between the ages of 18 - 69 years, eligible for the trial through screening test prior to the enrollment 2. Able and willing to perform the study protocol and participate throughout the entire trial period (screening, baseline, 3, 6 weeks, 8 week-follow up [if needed]) 3. Participants who understood the study thoroughly and signed a written informed consent 4. Among individuals not under diabetes mellitus treatment, whose random glucose concentration is 110~250 mg/dL measured with Accu-Chek® glucometer within 3 weeks prior to participation 4.1. Fasting plasma glucose concentration 100-190mg/dl or 4.2. 2-hour plasma glucose concentration* 130-250 mg/dl (*venous plasma glucose 2-hour after ingestion of 75g oral glucose load)
Exclusion criteria
Exclusion criteria: 1. Presently using other blood glucose level controlling agents 2. History of allergy to the herbal products(bitter orange and Mulberry leaves) or allergic diseases such as asthma 3. Medication (within the last 1 month or during the study) which would affect the study results 4. Daily intake of alcoholic beverages 5. Smokers consuming more than 1 pack/day 6. Presently having acute diseases or other untreated illness requiring treatment 7. Impaired hepatic or renal functions 8. Pregnant, breast feeding status or female of reproductive age, not using proper contraception 9. Participant in other clinical trials or a blood donor, within the past 1 month 10. History of severe disease or any condition, in the investigator?s opinion, that would endanger the individual?s safety or affect the study result 11. Patients with type I and type II diabetes mellitus (insulin requiring stage)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Glycated haemoglobin (HbA1c) 2. Fructosamine 3. Fasting glucose 4. 2-hour Oral Glucose Tolerance Test (OGTT) 5. Fasting insulin 6. Total cholesterol 7. Triglyceride 8. Low density lipoprotein (LDL) cholesterol Assessing the difference between baseline and 6 week measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scale (VAS): 1.1. Polydipsia 1.2. Polyuria 2. Other clinically significant parameters 3. Anthropometric parameters: 3.1. Body weight 3.2. Waist circumference 3.3. Hip circumference | — |
Countries
Korea, South
Outcome results
None listed