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Trial registered on ANZCTR


Registration number
ACTRN12611000655943
Ethics application status
Approved
Date submitted
25/06/2011
Date registered
27/06/2011
Date last updated
28/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of mulberry, red ginseng and banaba in the regulation of blood glucose and insulin responses in type 2 diabetes
Scientific title
A six-month supplementation of mulberry, Korean red ginseng and banaba decreases biomarkers of systemic low grade inflammation in subjects with impaired glucose tolerance and type 2 diabetes
Secondary ID [1] 262478 0
Nil
Universal Trial Number (UTN)
U1111-1122-4176
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 268168 0
Impaired glucose tolerence 268169 0
Condition category
Condition code
Alternative and Complementary Medicine 268300 268300 0 0
Herbal remedies
Metabolic and Endocrine 268305 268305 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6g/day (2g x 3 times a day) of 1:1:1 mixture of the herbal preparation for 24 weeks. (6g/day of herabl preparation was consisted of 2g/day of Korean red ginseng, 2g/day of Muberry leaf, 2g/day of banaba leaf)


Speficification of herbal preparation:
Korean red ginseng (Panax ginseng C.A. Mayer) powder, mulberry (Morus alba L.) leaf water extract powder, and banaba (Lagerstroemia speciosa L.) leaf water extract powder

The mode of administration: oral capsule
Intervention code [1] 266832 0
Prevention
Intervention code [2] 266837 0
Treatment: Other
Comparator / control treatment
Placebo control (corn starch)
Control group
Placebo

Outcomes
Primary outcome [1] 269041 0
AUCg (area under the curve of blood glucose) value based on the 75 g oral glucose tolerence test
Timepoint [1] 269041 0
baseline, 3 months, 6 months
Secondary outcome [1] 276853 0
AUCi (area under the curve of blood insulin) value
Timepoint [1] 276853 0
baseline, 3 months, 6 months
Secondary outcome [2] 276854 0
blood inflammation markers:
ICAM, VCAM, ox-LDL, Lp(a), PAI-1, hs-CRP
Timepoint [2] 276854 0
baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
1) Subjects diagnosed with the impaired glucose tolerence
2) Subjects diagnosed with type 2 diabetes taking one or the combination of following mediations and have not changed the prescription for at least two months.
Mediations: sulfonylurea, biguanide, alpha-gludosidase
3) Subjects with BMI over 20kg/m2, non-pregnant who has not taken herbs at least for last 3 months
Minimum age
35 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients taking insulin or medications other than sulfonylurea, biguanide or alpha-glucosidase during last 2 months
2)Individuals with chronic liver diseases, advanced kidney di se ases, atherosclerosis, myocardial infarction, pulmonary diseases, gastrointestinal diseases, hematological diseases and cancer
3) Individuals receiving or have received pharmacological doses of steroids and/or participating weight reduction programs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was performed using a randomization table generated by using SAS program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3675 0
Korea, Republic Of
State/province [1] 3675 0
Seoul

Funding & Sponsors
Funding source category [1] 267303 0
Government body
Name [1] 267303 0
The Ministry for Food, Agriculture, Forestry and Fisheries
Address [1] 267303 0
Gwacheon Government Complex, 88, Gwacheon-si, Gyeonggi-do 427-719
Country [1] 267303 0
Korea, Republic Of
Primary sponsor type
University
Name
Sookmyung Women's University
Address
Department of Food and Nutrition, Sookmyung Women's University, 52 Hyochangwon-gil, Yongsan-gu, Seoul 140-742
Country
Korea, Republic Of
Secondary sponsor category [1] 266369 0
Hospital
Name [1] 266369 0
Seoul St. Mary's Hospital
Address [1] 266369 0
Department of Endocrinology, The Catholic University of Korea, Seoul St. Mary's Hospital, 505 Banpo-dong, Seocho-gu, Seoul 137-040
Country [1] 266369 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269297 0
Institutional Review Board of Seoul St. Mary's Hospital
Ethics committee address [1] 269297 0
Seoul St. Mary's Hospital
505 Banpo-dong, Seocho-gu, Seoul 137-040
Ethics committee country [1] 269297 0
Korea, Republic Of
Date submitted for ethics approval [1] 269297 0
Approval date [1] 269297 0
19/04/1997
Ethics approval number [1] 269297 0
KCMC070T016

Summary
Brief summary
To evaluate the long-term efficacy and safety of traditionally used anti-diabetic herbs in controlling blood glucose homeostasis and low grade inflammation, a six month clinical trial was performed with red ginseng roots, mulberry leaf water extract, and banaba leaf water extract in subjects with impaired glucose tolerance or mild cases of T2D.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32795 0
Address 32795 0
Country 32795 0
Phone 32795 0
Fax 32795 0
Email 32795 0
Contact person for public queries
Name 16042 0
Sun Choi
Address 16042 0
Clinical Research Coordination Center
Seoul St. Mary's Hospital
505 Banpo-dong, Seocho-gu, Seoul 137-040
Country 16042 0
Korea, Republic Of
Phone 16042 0
+82-2-590-2679
Fax 16042 0
+82-2-590-2694
Email 16042 0
gomae37@gomae.co.kr
Contact person for scientific queries
Name 6970 0
Mi-Kyung Sung
Address 6970 0
52 Hyochangwon-gil, Yongsan-gu, Seoul 140-742
Country 6970 0
Korea, Republic Of
Phone 6970 0
+82-2-710-9395
Fax 6970 0
+82-2-710-9453
Email 6970 0
mksung@sm.ac.kr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary