CHM for T2DM & MetS

Launched by HONG KONG BAPTIST UNIVERSITY · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special treatment using Chinese Herbal Medicine (CHM) on people with Type 2 Diabetes Mellitus (T2DM) who also have Metabolic Syndrome (MetS). The trial will include 15 patients from the community who are diagnosed with T2DM and have been living with it for no more than 5 years. To participate, individuals must be between the ages of 30 and 75, have certain health measurements related to blood pressure, weight, and sugar levels, and meet specific criteria for Metabolic Syndrome.

Participants will undergo a 4-week treatment with herbal granules made from six different Chinese herbs. During this time, researchers will monitor various health factors such as blood sugar levels, blood pressure, and cholesterol. They will also track participants' physical activity and quality of life. This trial is not yet recruiting, and it’s important to note that individuals with certain serious health conditions or allergies to herbal medicines will not be eligible to participate. If you or someone you know fits the criteria, this could be an opportunity to explore a new treatment approach for managing diabetes and related health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 30-75y.
• • Diagnosed with Type 2 diabetes no more than 5 years.
• • Having current prehypertension (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89mmHg), or with a history of hypertension (systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg).
• • Diagnosed with Metabolic Syndrome according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) from Chinese Diabetes Society. People who meet 3 of the following diagnostic criteria or more can be diagnosed as Metabolic Syndrome: (a)Abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) Hyperglycemia: Fasting blood glucose ≥ 6.1mmol/L or 2-hour postprandial glucose ≥ 7.8mmol/L and/or those who have been diagnosed with hyperglycemia and in treatment; (c) Hypertension: blood pressure ≥ 130/85mmHg and/or those who have been diagnosed with hypertension and in treatment; (d) Fasting triglyceride ≥ 1.70mmol/L; (e) Fasting HDL-C \< 1.04mmol/L.
• • Diagnosed with Accumulation of phlegm and dampness pattern or Intertwined phlegm and blood stasis pattern based on Traditional Chinese Medicine (TCM) theory.
• • Stable vital signs and with sufficient sensorimotor and language competency for completing assessments.
• Exclusion Criteria:
• • Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the CHM.
• • Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
• • Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
• • Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
• • Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
• • Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
• • Experienced at least one day of diarrhea in the past 7 days.
• • With previous stroke history.
• • With unconsciousness, aphasia, and cognitive dysfunction.
• • With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
• • Pregnancy or lactation female.
• • Had joined other clinical trial within past 4 weeks.