None listed
Conditions
Brief summary
This study aims to 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 trialParticipants will be male or female, aged greater than or equal to 18 years, with type 2 diabetes treated with metformin as monotherapy and with suboptimal glycaemic control as evidenced by a glycosylated haemoglobin (HbA1c) level between 7% and 9%. Participants will be recruited from a large GP centre in Sydney. Awareness of the study will be via the University of Technology Sydney website, and by advertising in the Medical Centre. Study Drugs: T50 (a sachet formulation of Chinese herbal extracts)
Interventions
• 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 Min
• 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.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed