Trial from ANZCTR


Trial ID ACTRN12612000128897
Trial Status: Registered
Date Submitted: 26/01/2012
Date Registered: 30/01/2012
Retrospectively registered

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Public title Clinical trial of a Chinese herbal medicine for the treatment of prediabetes and mild diabetes
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Randomised controlled trial of Jiangtang Xiaozhi compared to placebo for the treatment of prediabetes and mild diabetes
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Secondary ID [1] 279798 0
Nil
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UTN
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Trial acronym
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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
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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
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Condition category: Condition code:
Metabolic and Endocrine Diabetes
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Alternative and complementary medicine Herbal remedies
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285885 285885 0 0

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Descriptions 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
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Intervention Code:
Treatment: Other 284123 0
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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
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Control group Placebo
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Primary Outcome: Glycaemic control: fasting blood glucose measured by analysis of blood samples collected by venipuncture 286362 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 286362 0
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Primary Outcome: Glycosylated haemoglobin (HBA1c) measured by analysis of blood samples collected by venipuncture. 286363 0
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Timepoint: At baseline, 16 weeks, 24 weeks 286363 0
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Primary Outcome: 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. 286364 0
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Timepoint: At baseline, 16 weeks, 24 weeks 286364 0
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Secondary Outcome: 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. 295681 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295681 0
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Secondary Outcome: Total cholesterol measured by analysis of blood samples collected by venipuncture. 295682 0
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Timepoint: At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295682 0
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Secondary Outcome: HDL cholesterol measured by analysis of blood samples collected by venipuncture. 295683 0
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Timepoint: At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295683 0
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Secondary Outcome: C-reactive protein measured by analysis of blood samples collected by venipuncture. 295684 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295684 0
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Secondary Outcome: 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. 295685 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295685 0
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Secondary Outcome: Body Mass Index (BMI) was calculated by weight (measured to within 0.1kg) divided by height (measured to within 0.5cm) squared 295686 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295686 0
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Secondary Outcome: Waist-hip ratio (WHR) was obtained by dividing the mean waist girth by the mean hip-girth. 295687 0
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Timepoint: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295687 0
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Secondary Outcome: 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. 295688 0
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Timepoint: At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295688 0
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Secondary Outcome: Triglycerides measured by analysis of blood samples collected by venipuncture. 295689 0
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Timepoint: At baseline, 8 weeks, 12 weeks, 16 weeks and at follow-up at 24 weeks 295689 0
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Secondary Outcome: 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). 295690 0
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Timepoint: At baseline, 16 weeks, 24 weeks 295690 0
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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.
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Minimum age 18 Years
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Maximum age 80 Years
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Gender Both males and females
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Healthy volunteers? Yes
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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
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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'.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 2 / Phase 3
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Anticipated date of first participant enrolment 28/06/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 100
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2250 4881 0
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Postcode: 2124 4882 0
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Postcode: 2200 4883 0
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Recruitment outside Australia

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Funding Source: University 284576 0
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Name: University of Western Sydney 284576 0
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Address: University of Western Sydney
Locked Bag 1797 Penrith South DC NSW 2751
284576 0
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Country: Australia 284576 0
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Primary Sponsor Hospital
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Name: Xiyuan Hospital
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Address: No. 1 Xi Yuan Cao Chang
Haidian District, Beijing, 100091
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Country: China
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Secondary Sponsor: None 283493 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Human Research Ethics Committee at University of Western Sydney 286561 0
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Address: University of Western Sydney
Locked Bag 1797 Penrith South DC NSW 2751
286561 0
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Country: Australia 286561 0
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Approval Date: 20/01/2007 286561 0
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Submitted Date: 20/11/2006 286561 0
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HREC: 1/06/0194 286561 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Suzannah Bourchier
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Address: University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751
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Country: Australia
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Tel: +6124620 3283
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Email: s.bourchier@uws.edu.au
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Contact person for scientific queries
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Name: Suzanne Grant
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Address: University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751
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Country: Australia
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Tel: +61419126209
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Email: s.grant@uws.edu.au
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Contact person responsible for updating information
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Name: Suzanne Grant
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Address: University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751
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Tel: +61419126209
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Email: s.grant@uws.edu.au
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Addition Cancer fields
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