Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: Chinese herbal medicine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201108
      • Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese herbal medicine; Individualized Treatment with Chinese herbal	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 Comparator: Placebo; Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Longhua Hospital; Shanghai Putuo District Center Hospital
• Investigators: Study Chair: Kaixian Chen, Ph.D, Shanghai Universitu of TCM

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 27, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Chinese herbal medicine; diabetes symptoms
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 06DZ19728-2; S06DZ19728 (Other Identifier: Shanghai University of TCM)