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

April 22, 2013
May 21, 2013
September 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01844050 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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.
  • Drug: Placebo
  • Experimental: Chinese herbal medicine
    Individualized Treatment with Chinese herbal
    Intervention: Drug: Chinese herbal medicine
  • Placebo Comparator: Placebo
    Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01844050
06DZ19728-2, S06DZ19728
Yes
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
  • Longhua Hospital
  • Shanghai Putuo Hospital
Study Chair: Kaixian Chen, Ph.D Shanghai Universitu of TCM
Shanghai University of Traditional Chinese Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP