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Trial registered on ANZCTR


Registration number
ACTRN12607000255482
Ethics application status
Approved
Date submitted
1/05/2007
Date registered
11/05/2007
Date last updated
4/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a Chinese herbal medicine formula in the management of simple obesity: Randomised placebo-controlled clinical trial
Scientific title
Efficacy and safety of a Chinese herbal medicine formula in the management of simple obesity: Randomised placebo-controlled clinical trial
Secondary ID [1] 288691 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1794 0
Condition category
Condition code
Diet and Nutrition 1880 1880 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised Double-blind Placebo-controlled trial
Each 500 mg capsule of Chinese herbal formula granule will contain Camellia sinenis (40%), Cassia obtusifolia (40%) , Sophora Japonica (20%).
Intervention code [1] 1726 0
Treatment: Other
Comparator / control treatment
The placebo capsule will be herbal starch that contains no active substances, which will have an identical appearance to the real herbal capsule. The granules of the formula and placebo will be in a standard capsule form produced by a manufacturer that holds TGA approved Good Manufacturing Practice (GMP) certificate.
The subject will be asked to take four capsules, three times daily for the period of 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2671 0
Subjects will be monitored for changes in anthropometric measurements: weight, body mass index (BMI), waist circumference, waist to hip ratio and body fat.
Timepoint [1] 2671 0
Assessments will be taken every 2 weeks: baseline, every 2 weeks until 12 weeks after the start of the intervention.
Secondary outcome [1] 4528 0
The secondary endpoints include specific quality of life questionnaire: Weight-Related Symptom Measure (WRSM) and Obesity & Weight-Loss Quality of Life measure (OWLQOL) and blood pressure .
Timepoint [1] 4528 0
These assessments will be taken every 2 weeks with the time points: baseline and every 2 weeks until 12 weeks after the start of the intervention.
Secondary outcome [2] 4529 0
Serological data: Cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, fasting insulin and glucose insulin sensitivity (HOMA-IR).
Timepoint [2] 4529 0
These assessments will be carried out at the baseline and end of week 12 of intervention.
Secondary outcome [3] 4530 0
Safety assessments of renal tests include Sodium, Potasium, Chlorite, Bicarbonate, Urea and Creatinine; and liver function tests are Total Bilirubin, Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphotase (ALP), Gamma Glutamyl Transferase (GGT),Total protein, Albumin, Globulin.
Timepoint [3] 4530 0
Will also be carried out by a pathology laboratory service at the baseline and end of week 12 of intervention.

Eligibility
Key inclusion criteria
•Subjects have BMI greater than 30 kg/m2;•Not involved in other clinical trials for the treatment of obesity; •Agree to avail themselves for the period of the study; and •Provide written consent for participation.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with one or more of the following conditions will be excluded from study:•Loosing more than 5kg in the past 3 months;•Endocrine disorders other than type 2 diabetes mellitus; •Uncontrolled hypertension; •Autoimmune or cardiovascular diseases or carrying pace-maker; •Lactating or pregnant women; •Those using drugs affecting the central nervous system or lipid lowering drugs;•Obesity known caused by pharmacotherapy;•Therapy for weight control in the last 6 months;•Kidney or hepatic disease;•Unable to read or understand English.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
clinician, assessor and participants are blinded
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
30/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 2027 0
University
Name [1] 2027 0
RMIT University
Country [1] 2027 0
Australia
Funding source category [2] 293049 0
Charities/Societies/Foundations
Name [2] 293049 0
Windermere foundation
Country [2] 293049 0
Australia
Primary sponsor type
Individual
Name
Prof. Charlia Xue
Address
School of Health Sciences
RMIT University
Country
Australia
Secondary sponsor category [1] 1838 0
Individual
Name [1] 1838 0
Prof. Yung Hsien Chang
Address [1] 1838 0
Nil Known
Country [1] 1838 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3759 0
Royal Melbourne Institute of Technilogy University, Clinical Trial Laboratory
Ethics committee address [1] 3759 0
Plenty Rd, Bundoora
Ethics committee country [1] 3759 0
Australia
Date submitted for ethics approval [1] 3759 0
Approval date [1] 3759 0
28/03/2007
Ethics approval number [1] 3759 0
04/07 Lenon

Summary
Brief summary
Trial will involve 80 obese subjects with BMI above 30. It will be randomised placebo controlled trial. Subjects will take Chinese herbal capsules for 12 weeks. The endpoints will be evaluated every 2 weeks.
Trial website
Trial related presentations / publications
1. Lenon , G; Li, K; Yang Li, C G; Cohen, M; Mann, N; Dacosta, C; Chang, Yung-Hsien; Xue, C. (2012). Efficacy and safety of a Chinese herbal medicine formula in the management of simple obesity: A randomized, placebo-controlled clinical trial. Evidence-base Complementary and Alternative Medicine.
2. Li, K., Yang, A. W., Xue, C. C. L., Lenon, G. B. (2013). Effects of traditional Chinese manual acupuncture for treatment of obesity: A systematic review. Australia and New Zealand Obesity Society (ANZOS) conference, Melbourne Australia.
3. Li, K., Yang, A. W., Xue, C. C. L., Lenon, G. B. (2013). Effects of traditional Chinese manual acupuncture for treatment of obesity: A systematic review. FCMA conference, Melbourne Australia.
4. Lenon , G; Li, K; Yang Li, Zhou, W (2012). Characteristics of obese individuals in Northern Melbourne suburbs: Screening assessment of potential subjects of Chinese herbal medicine clinical trial for simple obesity. ANZOS 2012. Auckland, New Zealand.
5. Lenon , G; Li, K; Yang Li, C G; Cohen, M; Mann, N; Dacosta, C; Chang, Yung-Hsien; Xue, C. (2010). Efficacy and safety of a Chinese herbal medicine formula in the management of simple obesity: A randomized, placebo-controlled clinical trial. 11th International Congress on Obesity. International Association for the Study of Obesity 11, 812–831. Stockholm, Sweden.
Public notes

Contacts
Principal investigator
Name 27829 0
Dr George Lenon
Address 27829 0
RMIT University
Plenty Rd
Bundoora
Country 27829 0
Australia
Phone 27829 0
99256587
Fax 27829 0
Email 27829 0
george.lenon@rmit.edu.au
Contact person for public queries
Name 10915 0
George Lenon
Address 10915 0
RMIT University
Building 202.4.13
Plenty Rd
Bundoora VIC 3083
Country 10915 0
Australia
Phone 10915 0
+61 3 99256587
Fax 10915 0
+61 3 99257178
Email 10915 0
george.lenon@rmit.edu.au
Contact person for scientific queries
Name 1843 0
George Lenon
Address 1843 0
RMIT University
Building 202.4.13
Plenty Rd
Bundoora VIC 3083
Country 1843 0
Australia
Phone 1843 0
+61 3 99256587
Fax 1843 0
+61 3 99257178
Email 1843 0
george.lenon@rmit.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEfficacy and Safety of a Chinese Herbal Medicine Formula (RCM-104) in the Management of Simple Obesity: A Randomized, Placebo-Controlled Clinical Trial2012https://doi.org/10.1155/2012/435702
N.B. These documents automatically identified may not have been verified by the study sponsor.