Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

This study has been completed.
Sponsor:
Collaborators:
Longhua Hospital
Shanghai Putuo Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01844050
First received: April 22, 2013
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Chinese herbal medicine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Change from Baseline Total score of diabetes symptoms at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline Fasting Blood Glucose at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline blood glucose at 2 hours after meal at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01844050

Locations
China, Shanghai
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 201108
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Longhua Hospital
Shanghai Putuo Hospital
Investigators
Study Chair: Kaixian Chen, Ph.D Shanghai Universitu of TCM
  More Information

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01844050     History of Changes
Other Study ID Numbers: 06DZ19728-2, S06DZ19728
Study First Received: April 22, 2013
Last Updated: May 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Chinese herbal medicine
diabetes symptoms

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014