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Trial registered on ANZCTR


Registration number
ACTRN12619001041145
Ethics application status
Approved
Date submitted
4/07/2019
Date registered
23/07/2019
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of The Chinese Herbal Medicine (T50) as Add-on Treatment to Metformin Monotherapy in Participants with Type 2 Diabetes Mellitus: A 12-week randomised, double-blind, placebo-controlled pilot clinical trial
Scientific title
Evaluation of The Chinese Herbal Medicine (T50) as Add-on Treatment to Metformin Monotherapy in Participants with Type 2 Diabetes Mellitus: A 12-week randomised, double-blind, placebo-controlled pilot clinical trial
Secondary ID [1] 298615 0
NCT: CT-2018-CTN-04055-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 313472 0
Condition category
Condition code
Metabolic and Endocrine 311902 311902 0 0
Diabetes
Alternative and Complementary Medicine 312029 312029 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Treatment Arm: metformin tablet (equal to 1000 mg/day) plus Tang Minling Pills (T50) 7.5g twice a day by oral administration. The duration of intervention is for 12 weeks.
• Control Arm: metformin tablet (equal to 1000 mg/day) plus placebo pills 7.5g twice a day by oral administration. The duration of intervention is for 12 weeks for 12 weeks.

• Strategies used to monitor adherence to the intervention of treatment arm and control arm:
Participants will receive a 4- weeks’ supply of Tang Minling or placebo Pills and prescribe 4 weeks' dosage of metformin tablets. The follow-up assessments (physical examination and laboratory tests) will be performed every four weeks during the treatment phase. All participants will be asked to return all empty pockets of investigational product for reconciliation at each follow-up assessment.

• The composition of Tang Minling Pill:
Investigational Product (IP) of T50 pill (Tang-Min-Ling-Wan, Tang Minling Pills) is a formulation derived from a classic formula described in the Treatise on Exogenous Febrile Diseases over 1000 years ago. The ingredients in manufactured T50 include herbal extracts of Dahuang (Rhei Radix et Rhizoma), Huanglian (Coptidis Rhizoma), Baishao (Paeoniae Radix Alba), Chaihu (Bupleuri Radix), Huangcen (Scutellariae Radix), Zhishi (Aurantii Fructus Immaturus), Qingbanxia (Pinelliae Rhizoma Praeparatum Cum Alumine), Shanzha (Crataegi Fructus), Wumei (Mume Fructus), and Tianhuafen (Trichosanthis Radix). The proportion for each component in the T50 formulation is based on dosage ranges in the Chinese Pharmacopeia 2015.
Intervention code [1] 314873 0
Treatment: Drugs
Intervention code [2] 314961 0
Treatment: Other
Comparator / control treatment

The placebo pills matched for colour, appearances and taste to Tang Minling Pills (T50 pills) will be administered orally 7.5 g twice daily. Metformin treatment continues unchanged throughout the study.

The contents of the placebo pills include polyethylene glycol, caramel pigment and opadry 85F66757 . The appearance (colour, size, shape and weight) of the matching placebo pills looks the same as T50 pills.
Control group
Placebo

Outcomes
Primary outcome [1] 320569 0
Change in HbA1c at 12 weeks relative to baseline for T50 compared with placebo will be assessed by measuring fasting plasma HbA1c.
Timepoint [1] 320569 0
The fasting plasma HbA1c will be assessed at baseline (before treatment), every four weeks during the treatment period and at the end of 12 weeks treatment.
Secondary outcome [1] 372070 0
Changes in metabolic parameter ( a composite including fasting plasma glucose, insulin levels and plasma lipid profile) relative to baseline and comparing to placebo control
Timepoint [1] 372070 0
The fasting blood sample for measuring glucose, insulin and lipid profiles will be collected at week 0 (before treatment), every four weeks during the treatment period and at the end of 12 weeks treatment.
Secondary outcome [2] 372440 0
Changes in insulin sensitivity relative to baseline and comparing to placebo control
Timepoint [2] 372440 0
Insulin sensitivity will be calculated using fasting plasma glucose and insulin levels for HOMA-IR and HOMA-ß at week 0 (before treatment), every four weeks during the treatment period and at the end of 12 weeks treatment.



Secondary outcome [3] 372441 0
Changes in body weight relative to baseline and comparing to placebo control
Timepoint [3] 372441 0
Body weight will be measured using a scale at week 0 (before treatment), every four weeks during the treatment period and at the end of 12 weeks treatment.
Secondary outcome [4] 372613 0
Tolerability of T50 in combination with metformin, e.g. stomach uncomfortable and diarrhoea, will be assessed by study-specific questionnaire and participant self-reported.
Timepoint [4] 372613 0
During the study period, the investigator or site staff will be responsible for detecting adverse effects which may be relevant to administration of T50 in combination with metformin at each follow-up assessment.
Secondary outcome [5] 372614 0
Changes in quality of life assessed using the ‘Traditional Chinese Medicine Symptom Scoring Standard’ and the Assessment of QoL questionnaire (AQOL).
Timepoint [5] 372614 0
The quality of life will be assessed using the ‘Traditional Chinese Medicine Symptom Scoring Standard’ and the Assessment of QoL questionnaire (AQOL) at week 0 (before treatment), every four weeks during the treatment period and at the end of 12 weeks treatment.

Eligibility
Key inclusion criteria
1. Male or Female, aged is equal to or greater than 18 and less than 80 years
2. A confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) based on American Diabetes Association (ADA) guidelines and taking a stable dose of metformin (equal to or greater than 1000 mg/day) as monotherapy for at least 1 month prior to screening.
3. A glycosylated haemoglobin (HbA1c) level between 7% and 9% at the screening visit.
4. Females of childbearing potential must have a negative pregnancy test, not be breast feeding and be established on a reliable method of contraception. Females must agree to remain on their established method of contraception throughout their participation in the study.
5. Participants who are able to understand and comply with all study related procedures.
6. Participants who give written informed consent having read the Information Sheet for volunteers.
7. Participant with ability to read and write English.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with type 1 diabetes.
2. Participants taking any glucose-lowering drugs other than metformin, and those on insulin.
3. Participants with poorly controlled hypertension (BP is greater than or equal to 200 mmHg systolic and/or greater than or equal to 110 mmHg diastolic).
4. Participants with a history of unstable angina or acute coronary syndrome within 3 months of screening.
5. Participants with moderate-to-severe heart failure (NYHA class III and above).
6. Participants with a history of pancreatitis.
7. Participants with a history of significant liver or kidney dysfunction:
• Liver function (serum ALT or AST is greater than 2.5 times the upper limit of normal laboratory range), or
• Estimated glomerular filtration rate (eGFR) is equal to 45 mL/min/1.73 m².
8. Untreated thyroid disease.
9. A history of systemic malignancy [participants with completely resected basal or squamous cell carcinoma of the skin, if treatment completed is greater than 6 months prior to enrolment and participant is in remission for is greater than 5 years prior to Screening, remain eligible].
10. History of alcohol or illicit drug abuse.
11. History of allergy to herbal medicine products.
12. Females of child-bearing potential who are pregnant, breast-feeding infants or intending to become pregnant or not using adequate contraception.
13. Participants may also be excluded if, in the opinion of the GP investigators, they have other medical conditions that may adversely affect the outcome of the study, including diabetic retinopathy.
14. Participated in a clinical trial in the last 2 months.
15. Those who are unable to commit to the appointment schedule or perform the tasks required in 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)

Medical Investigator and Principal Investigator will determine the eligible participants according criteria of inclusion and exclusion. Participants will be dispensed study product in the visit pack with a central computer generated randomisation number by a staff member who is not involved in the clinical conduct of the trial at the study centre.

numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table will be generated by unblind statisticians using SAS proc plan procedure statements with computer, specifying the number of seeds, block length, number of blocks, number of treatment groups and treatment ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed for normality using the Shapiro-Wilk test. For analysis of differences between treatments, unpaired t-test, an analysis of co-variance (ANCOVA), or the non-parametric equivalent (Chi squared test) will be used. As well as an analysis of completers (those that attend the final visit), an intention to treat (ITT) analysis will also be included. For the ITT analysis, dropouts will be treated using a variety of sensitivity analyses.
With respect to a significant reduction of HbA1c at least 0.5% of baseline value, which is also at least 5% greater than that associated with placebo, is considered to be a valid efficacy criterion in clinical trials evaluating new anti-diabetes treatments.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/08/2019
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)
NSW

Funding & Sponsors
Funding source category [1] 303157 0
Commercial sector/Industry
Name [1] 303157 0
Tasly Pharmaceuticals Group Co., LTD
Country [1] 303157 0
China
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 303154 0
Commercial sector/Industry
Name [1] 303154 0
Healthpac Centre of Excellence in Integrative Medicine Pty Ltd
Address [1] 303154 0
7-11 The Avenue, Hurstville, NSW, 2220
Country [1] 303154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303716 0
UTS Human Research Ethics Clinical Trials Subcommittee
Ethics committee address [1] 303716 0
Ethics committee country [1] 303716 0
Australia
Date submitted for ethics approval [1] 303716 0
Approval date [1] 303716 0
15/04/2019
Ethics approval number [1] 303716 0
ETH18-2850

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94558 0
A/Prof Xianqin Qu
Address 94558 0
School of Life Sciences
Faculty of Science CB7/CB4
University of Technology Sydney
15 Broadway, Ultimo, NSW 2007
Country 94558 0
Australia
Phone 94558 0
+61 2 9514 7852
Fax 94558 0
Email 94558 0
Xianqin.Qu@uts.edu.au
Contact person for public queries
Name 94559 0
Ven Tan
Address 94559 0
Medicentral at Sydney CBD
Level 11, 501 George Street, Sydney, NSW 2000
Country 94559 0
Australia
Phone 94559 0
+61 2 8378 6666
Fax 94559 0
Email 94559 0
ventan@healthpac.com.au
Contact person for scientific queries
Name 94560 0
Xianqin Qu
Address 94560 0
School of Life Sciences
Faculty of Science CB7/CB4
University of Technology Sydney
15 Broadway, Ultimo, NSW 2007
Country 94560 0
Australia
Phone 94560 0
+61 2 9514 7852
Fax 94560 0
Email 94560 0
Xianqin.Qu@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2837Informed consent form  xianqin.qu@uts.edu.au
2838Ethical approval  xianqin.qu@uts.edu.au



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.