Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844050
• Other study ID #: 06DZ19728-2
• Secondary ID: S06DZ19728
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2013
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Chinese 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.
• Placebo

Locations

Country	Name	City	State
China	Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital, Shanghai Putuo District Center Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Total score of diabetes symptoms at 4 weeks		0 weeks(baseline), 2 weeks, 4 weeks
Secondary	Change from Baseline Fasting Blood Glucose at 4 weeks		0 weeks(baseline), 2 weeks, 4 weeks
Secondary	Change from Baseline blood glucose at 2 hours after meal at 4 weeks		0 weeks(baseline), 2 weeks, 4 weeks