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Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01844050
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : May 22, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Chinese herbal medicine Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2008
Primary Completion Date : September 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herbal Medicine
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Total score of diabetes symptoms at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline Fasting Blood Glucose at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ]
  2. Change from Baseline blood glucose at 2 hours after meal at 4 weeks [ Time Frame: 0 weeks(baseline), 2 weeks, 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 District Center Hospital
Investigators
Study Chair: Kaixian Chen, Ph.D Shanghai Universitu of TCM
More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01844050     History of Changes
Other Study ID Numbers: 06DZ19728-2
S06DZ19728 ( Other Identifier: Shanghai University of TCM )
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

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