Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/08/2010
Date assigned
27/09/2010
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Seong-Gyu Ko

ORCID ID

Contact details

Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
Hoegi-Dong
Dongdaemun-Gu
Seoul
130-701
Korea
South

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 measures

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

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 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)

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

http://www.hpeb.re.kr/

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

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21310088

Publication citations

  1. 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.

Additional files

Editorial Notes