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NOT YET RECRUITING
NCT06978023
PHASE2

Novel Chinese Medicine Formula for Diabetes

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

Diabetes is a leading cause of heart disease, stroke, kidney failure, cancer and premature death. One in 10 adults are affected by diabetes. Early control of high blood gluocse prevents progressive deterioration and treatment escalation. People with diabetes have impaired insulin secretion, the only hormone that can lower blood glucose, or resistance to insulin action. There are trillions of microrganisms (tiny living things including bacteria) in the gut that can interact with foods and medicine to alter bodily functions including insulin secretion and its actions. Studies in animals and human suggested that a Traditional Chinese Medicine (TCM) containing a combination of four herbs (Jinmai, abbreviated as JM) reduced blood glucose by increasing insulin secretion accompanied by favorable changes in gut bacteria and expression of genetic information that regulate bodily functions. In this study, people with type 2 diabetes diagnosed for less than 6 years and not treated with any glucose lowering drugs are assigned randomly to recieve 1) high dose JM (JM-HD) or 2) low dose JM (JM-LD) or 3) look-alike dummy (placebo) given in powder form to be dissolved in water taken twice daily for 24 weeks. We shall compare the abilities of these 3 combination products to lower blood glucose over a 2-hour period after taking a nutritional drink at 0, 12 and 24 weeks. The assigned treatment will then be discontinued for 12 weeks and the test will be repeated to see if improvement is sustained. Samples will be collected at week 0 and 24 (on-treatment) and week 36 (12 weeks off-treament) to compare changes in gut bacteria in faeces and expression of genetic information that make proteins which regulate blood glucose amongst these 3 groups.

Official title: Clinical Safety, Efficacy and Multiomic Evaluation of a Novel Chinese Medicine Formula in Type 2 Diabetes: Effects on Beta-cell Function and Insulin Resistance

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2025-05

Completion Date

2027-02

Last Updated

2025-05-18

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

JM-LD

Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix Lonicerae Japonicae Flos (CAL) plus low dose extract of Ophiopogonis Radix

COMBINATION_PRODUCT

JM-HD

Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix, Lonicerae Japonicae Flos (CAL) plus high dose extract of Ophiopogonis Radix

COMBINATION_PRODUCT

Placebo

Placebo consisting of excipients, coloring and food ingredients to provide a powder mixture of same weight with similar color, texture and odour

Locations (1)

Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

Hong Kong, Hong Kong