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The efficacy and safety study of PURIAM110 on pre-diabetes, diabetes mellitus not insulin requiring stage Korean adults
ISRCTN ISRCTN44779824
DOI 10.1186/ISRCTN44779824
ClinicalTrials.gov identifier
EudraCT number
Public title The efficacy and safety study of PURIAM110 on pre-diabetes, diabetes mellitus not insulin requiring stage Korean adults
Scientific title The efficacy and safety study of PURIAM110 (dietary supplement) on pre-diabetes, diabetes mellitus not insulin requiring stage Korean adults: a randomised double-blind, placebo-controlled, multicentre clinical trial
Acronym PURIAM110
Serial number at source P110
Study hypothesis PURIAM110, a dietary supplement, might be useful for controlling blood glucose concentration in pre-diabetes, diabetes mellitus not insulin requiring stage Korean adults.

As of 14/12/2010 this record was updated to include an extended anticipated end date of 30/04/2011. The previous anticipated end date was 30/04/2007.
Lay summary Not provided at time of registration
Ethics approval 1. Institutional Review Board of the Kyung Hee Oriental Medical Center approved on the 21st November 2006 (ref: KOMC IRB 2006-14)
2. Institutional Review Board of the Kyung-won Gil Oriental approved on the 25th October 2006 (ref: 06-101)
Study design Multicentre randomised double blind placebo controlled clinical trial
Countries of recruitment Korea, South
Disease/condition/study domain Pre-diabetes, diabetes mellitus not insulin requiring stage.
Participants - 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)
Participants - 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)
Anticipated start date 01/12/2006
Anticipated end date 30/04/2011
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants A total of 45 subjects (treatment:placebo 2:1 = 30:15)
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 placebo group dosage is 2.760 mg (total 6 capsules) daily (460 ± 10 mg/1 capsule, 3 capsules/time, 2 times/day - 3 capsules before breakfast and 3 capsules before dinner), total 6 weeks.
Primary outcome measure(s) 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 outcome measure(s) 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
Sources of funding Ministry for Health, Welfare & Family Affairs (South Korea) - Korea Healthcare technology R&D Project (ref: A060793)
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21310088
Contact name Dr  Seong-Gyu  Ko
  Address Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
Hoegi-Dong
Dongdaemun-Gu
  City/town Seoul
  Zip/Postcode 130-701
  Country Korea, South
Sponsor Korea Health Industry Development Institute (KHIDI) (South Korea)
  Address Ministry for Health, Welfare & Family Affairs
57-1 Noryangjin-dong
Dongjak-gu
  City/town Seoul
  Zip/Postcode 156-800
  Country Korea, South
  Sponsor website: http://www.hpeb.re.kr/
Date applied 27/08/2010
Last edited 11/01/2012
Date ISRCTN assigned 27/09/2010
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