Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Chinese herbal medicine

• Registration Number: NCT01844050
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-27
• Status Verified: 2013-05
• Study First Posted: 2013-05-01
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.
Chinese herbal medicine	Chinese herbal medicine	Individualized Treatment with Chinese herbal

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China