Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P110
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Pre-diabetes, diabetes mellitus not insulin requiring stage.
Intervention
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.
Intervention type
Other
Phase
Phase II/III
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/12/2006
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 45 subjects (treatment:placebo 2:1 = 30:15)
Participant 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 investigators opinion, that would endanger the individuals safety or affect the study result
11. Patients with type I and type II diabetes mellitus (insulin requiring stage)
Recruitment start date
01/12/2006
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Preventive Medicine
Seoul
130-701
Korea, South
Sponsor information
Organisation
Korea Health Industry Development Institute (KHIDI) (South Korea)
Sponsor details
Ministry for Health
Welfare & Family Affairs
57-1 Noryangjin-dong
Dongjak-gu
Seoul
156-800
Korea
South
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Ministry for Health, Welfare & Family Affairs (South Korea) - Korea Healthcare technology R&D Project (ref: A060793)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21310088
Publication citations
-
Protocol
Park S, Park JS, Go H, Jang BH, Shin Y, Ko SG, The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study., Trials, 2011, 12, 38, doi: 10.1186/1745-6215-12-38.