Novel Chinese Medicine Formula for Diabetes

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.

Conditions

• Type 2 Diabetes

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

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Juliana CN CHAN, MD · CUHK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-31

Primary Completion

2026-10-31

Completion

2027-02-28

Countries

• Hong Kong

Study Locations