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Trial registered on ANZCTR


Registration number
ACTRN12612000128897
Ethics application status
Approved
Date submitted
26/01/2012
Date registered
30/01/2012
Date last updated
30/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical trial of a Chinese herbal medicine for the treatment of prediabetes and mild diabetes
Scientific title
Randomised controlled trial of Jiangtang Xiaozhi compared to placebo for the treatment of prediabetes and mild diabetes
Secondary ID [1] 279798 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired glucose tolerance defined as having a fasting blood glucose <7.8 mmol and a 2 hour post prandial blood glucose >7.8 but <11.00 285702 0
Mild diabetes defined as those with diabetes diagnosed within 5 yrs of enrolment in the clinical trial, diet and exercise controlled and not taking any medications. 285703 0
Condition category
Condition code
Metabolic and Endocrine 285865 285865 0 0
Diabetes
Alternative and Complementary Medicine 285885 285885 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Jiangtang Xiaozhi at a dosage of 3 capsules 3 times per day for 16 weeks. Jiangtang Xiaozhi comprises six herbs and two excipients: Ligustrum lucidum, Astragalus membranaceus (Fisch.), Coptis chinensis, Litchi chinensis, Ecklonia kurome Curcuma longa, Lactose, Magnesium stearate
Intervention code [1] 284123 0
Treatment: Other
Comparator / control treatment
Placebo capsules at a dosage of 3 capsules 3 times per day for 16 weeks. Placebo comprises lactose, microcrystalline cellulose, dextrin, fresh carrot juice and Denatonium Benzoate
Control group
Placebo

Outcomes
Primary outcome [1] 286362 0
Glycaemic control: fasting blood glucose measured by analysis of blood samples collected by venipuncture
Timepoint [1] 286362 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Primary outcome [2] 286363 0
Glycosylated haemoglobin (HBA1c) measured by analysis of blood samples collected by venipuncture.
Timepoint [2] 286363 0
At baseline, 16 weeks, 24 weeks
Primary outcome [3] 286364 0
Post-prandial plasma glucose measured by analysis of blood samples collected by venipuncture following an overnight fast of at least 10-12 hours and 3 days of carbohydrate loading. A standard 75-g oral glucose tolerance test was performed.
Timepoint [3] 286364 0
At baseline, 16 weeks, 24 weeks
Secondary outcome [1] 295681 0
Serum insulin measured by analysis of blood samples collected by venipuncture. Insulin resistance (HOMA-IR), Insulin sensitivitiy (HOMA%S) are calculated using the Homeostatic model assessment (HOMA) (Levy, Matthews, & Hermans, 1998). The HOMA calculations in this research were derived from the HOMAV2.2 computer package which estimates steady state beta cell function (HOMA%B) and insulin sensitivity (HOMA%S), as percentages of a normal reference population.
Timepoint [1] 295681 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [2] 295682 0
Total cholesterol measured by analysis of blood samples collected by venipuncture.
Timepoint [2] 295682 0
At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [3] 295683 0
HDL cholesterol measured by analysis of blood samples collected by venipuncture.
Timepoint [3] 295683 0
At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [4] 295684 0
C-reactive protein measured by analysis of blood samples collected by venipuncture.
Timepoint [4] 295684 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [5] 295685 0
Weight measured after removal of shoes and when wearing light clothing only, using A&D Digital Scales (Model UC-321) and recorded to the nearest 0.1 kg.
Timepoint [5] 295685 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [6] 295686 0
Body Mass Index (BMI) was calculated by weight (measured to within 0.1kg) divided by height (measured to within 0.5cm) squared
Timepoint [6] 295686 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [7] 295687 0
Waist-hip ratio (WHR) was obtained by dividing the mean waist girth by the mean hip-girth.
Timepoint [7] 295687 0
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [8] 295688 0
Blood pressure was measured in a seated position after the participant had rested for at least 5 minutes. Two readings on the left arm were taken 1 minute apart. To obtain the final measure of blood pressure, the mean of the two readings was calculated and recorded.
Timepoint [8] 295688 0
At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [9] 295689 0
Triglycerides measured by analysis of blood samples collected by venipuncture.
Timepoint [9] 295689 0
At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks
Secondary outcome [10] 295690 0
Health related quality of life (SF-36). The instrument selected to assess HRQoL was the 36-item short-form health survey Version 2 (SF-36v2).
Timepoint [10] 295690 0
At baseline, 16 weeks, 24 weeks

Eligibility
Key inclusion criteria
Participants must have either:
1. fasting blood glucose level of <7.0 mmol/L AND 2 hr plasma glucose level >7.8 <11.1 OR
2. be diagnosed with diabetes within the last five years and have their diabetes diet and exercised controlled and NOT taking any medication.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
individuals with conditions or treatments that would interfere with participation or completion of the protocol, or that had a confounding effect on the outcomes of the study

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)
Placebo and intervention were identical in appearance, taste and smell. A trial coordinator (external to the trial) supplied labelled packets of the intervention as required. The data anaylsis was conducted with the interventions known simply as 'A' and 'B'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence in a simple block was computer-generated by the Trial Coordinator (who was external to the trial). The medication was sealed in sequentially numbered identical packets according to the allocation sequence. Each individual was assigned a unique three-digit participant identifier number that matched the labelled packets. This number was used in all electronic and paper based data collection items.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4881 0
2250
Recruitment postcode(s) [2] 4882 0
2124
Recruitment postcode(s) [3] 4883 0
2200

Funding & Sponsors
Funding source category [1] 284576 0
University
Name [1] 284576 0
University of Western Sydney
Country [1] 284576 0
Australia
Primary sponsor type
Hospital
Name
Xiyuan Hospital
Address
No. 1 Xi Yuan Cao Chang
Haidian District, Beijing, 100091
Country
China
Secondary sponsor category [1] 283493 0
None
Name [1] 283493 0
Address [1] 283493 0
Country [1] 283493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286561 0
Human Research Ethics Committee at University of Western Sydney
Ethics committee address [1] 286561 0
University of Western Sydney
Locked Bag 1797 Penrith South DC NSW 2751
Ethics committee country [1] 286561 0
Australia
Date submitted for ethics approval [1] 286561 0
20/11/2006
Approval date [1] 286561 0
20/01/2007
Ethics approval number [1] 286561 0
1/06/0194

Summary
Brief summary
This trial assessed the effectiveness of a Chinese herbal medicine to normalise blood glucose and insulin levels. Participants were randomly divided into two groups. Group 1 received the Chinese Herbal Formula and Group 2 received a placebo which had no treatment effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33683 0
Address 33683 0
Country 33683 0
Phone 33683 0
Fax 33683 0
Email 33683 0
Contact person for public queries
Name 16930 0
Suzannah Bourchier
Address 16930 0
University of Western Sydney
Locked Bag 1797 Penrith South DC NSW 2751
Country 16930 0
Australia
Phone 16930 0
+6124620 3283
Fax 16930 0
Email 16930 0
[email protected]
Contact person for scientific queries
Name 7858 0
Suzanne Grant
Address 7858 0
University of Western Sydney
Locked Bag 1797 Penrith South DC NSW 2751
Country 7858 0
Australia
Phone 7858 0
+61419126209
Fax 7858 0
Email 7858 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.