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
Protocol serial number	P110
Sponsor	Korea Health Industry Development Institute (KHIDI) (South Korea)
Funder	Ministry for Health, Welfare & Family Affairs (South Korea) - Korea Healthcare technology R&D Project (ref: A060793)

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

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PURIAM110
Study objectives	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(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) studied	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
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.
Key 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
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	45
Key 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)
Key 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)
Date of first enrolment	01/12/2006
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Preventive Medicine

Seoul
130-701
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2020: Internal review.