A 12week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Boehmeria nivea extract on improving blood glucose.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000846

Enrollment

Registered

2013-09-13

Start date

2013-09-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test group (Boehmeria nivea extract) or control group (Placebo) for 12 weeks Intake: twice a day, once ingested 4 capsules with each meal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Adults aged 20 years old or more and less than 65 years old ? Fasting glucose > 100 mg/dl and < 125 mg/dl or 75g oral GTT post-prandial 2 hour value of 140-199 mg/dl on screening ? Subjects who agree the participation in the trial and submit informed consent before the beginning of the trial

Exclusion criteria

Exclusion criteria: ? Subjects who had surgery previously within 6 months before the trial ? Subjects who had insulin therapy, and/or oral hypoglucosuric agent previously within 3 months before the trial ? Subjects who took corticosteroid drug previously within 2 months before the trial ? TSH 10 uU/ml ? More than 2 times upper limit of creatinine ? More than 3 times upper limit of AST and/or ALT ? Subjects who complains of indigestion, gastric soreness or severe GI symptoms ? Subjects who are admitted, taking medicine, or having rehabilitation treatment due to alcohol abuse, cardiac disease, or CNS diseases on history taking ? Malnutrition or poor nutritional status ? Pregnant or possibility of pregnancy, or breast feeding mothers ? Designated persons who will take part in the other trial during this trial ? Subjects who had taken part in the other trial previously within 3 months before the trial ? Inappropriate person decided by investigator

Design outcomes

Primary

Measure	Time frame
Fasting blood glucose;2 hours postprandial blood glucose (OGTT);OGTT, AUC(0~2hr);HbA1c;Insulin;C-peptide;HOMA-IR, HOMA-beta, QUICKI, Matsuda index	—

Secondary

Measure	Time frame
Adverse events;Clinical pathology (hematology / blood chemical tests, urine tests);Vital signs (pulse, blood pressure);Electrocardiogram;Weight	—

Countries

Korea, Republic of

Contacts

Public ContactKang suk

Hallym University Medical Center

Outcome results