The efficacy and safety study of PURIAM110 on pre-diabetes, diabetes mellitus not insulin requiring stage Korean adults

ISRCTN ISRCTN44779824
DOI https://doi.org/10.1186/ISRCTN44779824
Secondary identifying numbers P110
Submission date
27/08/2010
Registration date
27/09/2010
Last edited
18/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Seong-Gyu Ko
Scientific

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

Study information

Study designMulticentre randomised double blind placebo controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe 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
Study acronymPURIAM110
Study objectivesPURIAM110, 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(s)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)
Health condition(s) or problem(s) studiedPre-diabetes, diabetes mellitus not insulin requiring stage.
Intervention1. 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/12/2006
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA total of 45 subjects (treatment:placebo 2:1 = 30:15)
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment01/12/2006
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Preventive Medicine
Seoul
130-701
Korea, South

Sponsor information

Korea Health Industry Development Institute (KHIDI) (South Korea)
Research organisation

Ministry for Health, Welfare & Family Affairs
57-1 Noryangjin-dong
Dongjak-gu
Seoul
156-800
Korea, South

http://www.hpeb.re.kr/
ROR logo https://ror.org/00fdzyk40

Funders

Funder type

Government

Ministry for Health, Welfare & Family Affairs (South Korea) - Korea Healthcare technology R&D Project (ref: A060793)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/02/2011 Yes No

Editorial Notes

18/12/2020: Internal review.

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