Background
Methods/design
Objectives & Hypothesis
Objectives
Hypothesis
Study design
Population
Inclusion criteria | |
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1. | Both gender between the ages of 18-69 years, eligible for study through screening test prior to the enrolment. |
2. | Able and willing to perform the study protocol and participate throughout the entire trial period(Screening, baseline, 3, 6 weeks, follow up(if needed)). |
3. | Participants who understood the risks and benefits of the study 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®(Roche, Germany) glucometer within 3 weeks prior to participation. |
4.1. | fasting plasma glucose concentration is 100-190 mg/dL or |
4.2. | 2- hour plasma glucose concentration* is 130-250 mg/dL( * venous plasma glucose 2-hour after ingestion of 75 g oral glucose load; DIASOL-S LIQ. [Glucose] Taejoon Pharm.) |
Exclusion criteria | |
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1. | Presently using other blood glucose level controlling agents. |
2. | History of allergy to the herbal products (bitter oranges 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 diagnosed as type I and type II diabetes mellitus(insulin requiring stage). |
Inclusion and exclusion criteria
Inclusion criteria
Exclusion criteria
Suspension criteria
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Administration of forbidden medicine.
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Subject's demand to discontinue the study.
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Serious adverse events (AE) or unusual changes in clinical test results.
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Principal investigator's decision to terminate the study (low rates of compliance, complications, or unable to sustain the study for various reasons).
Sample size
Randomization
Blinding
Interventions
Treatment drug
PURIAM110 (460 mg/1 hard gelatin capsule) |
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bitter oranges (zhi shi, Fructus Aurantii; the unriped fruits of Citrus aurantium L.) |
mulberry leaves (sang ye, the dried leaf of Folium Mori) |
Sodium Silica Aluminate (lubricants) |
Constituents of PURIAM110
Placebo
Directions
Study groups
Study period
Outcomes
Efficacy assessment index
Primary outcome index
Secondary outcome index
Safety assessment index
Procedures
Recruitment
Study schedule & test items per visit
Screening* Visit 1 | Baseline Visit 2 | Visit 3 | Visit 4 | Follow up (Visit 5) | |
---|---|---|---|---|---|
D-21 ~D-1 | D0 Week 0 | D21 Week 3 | D42 Week 6 | D56 Week 8 | |
Informed consent form | ● | ||||
Demographic information taking 1
| ● | ||||
Medical history taking | ● | ||||
Finger-prick blood glucose testing | ● | ||||
QSCC II 2
| ● | ||||
Inclusion/exclusion criteria check | ● | ||||
Physical examination 3
| ● | ● | ● | ● | |
Vital sign measurement 4
| ● | ● | ● | ● | |
Laboratory test 5
| ● | ● | ● | ● | |
VAS 6
| ● | ● | ● | ● | |
Electrocardiogram(ECG) | ● | ● | |||
Concomitant drugs check | ● | ● | ● | ● | |
Treating physician examination 7
| ● | ● | ● | ● | |
Adverse event monitoring | ● | ● | ● | ||
Compliance checking | ● | ||||
Study drug distribution | ● | ● | |||
Smoking, drinking, coffee taking status 8
| ● | ||||
Diet, physical exercise Counseling 8
| ● | ● |