Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01844050

Enrollment

120

Registered

2013-05-01

Start date

2008-09-30

Completion date

2009-10-31

Last updated

2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Chinese herbal medicine, diabetes symptoms

Brief summary

Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.

Interventions

DRUGChinese herbal medicine

According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms. * After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\<2h PG\<16mmol/l * Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine. * Subject is willing to participate and capable of giving informed consent.

Exclusion criteria

* Those patients used any drugs for treatment of diabetes within one month. * Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system. * Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month. * Women who were pregnant, lactating or planned pregnant. * Allergic constitution and has a history of drug allergy. * Combined with severe acute or chronic infections.

Design outcomes

Primary

Measure	Time frame
Change from Baseline Total score of diabetes symptoms at 4 weeks	0 weeks(baseline), 2 weeks, 4 weeks

Secondary

Measure	Time frame
Change from Baseline Fasting Blood Glucose at 4 weeks	0 weeks(baseline), 2 weeks, 4 weeks
Change from Baseline blood glucose at 2 hours after meal at 4 weeks	0 weeks(baseline), 2 weeks, 4 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026