Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
2 other identifiers
interventional
120
1 country
1
Brief Summary
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedJune 12, 2019
May 1, 2013
1 year
April 22, 2013
June 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Total score of diabetes symptoms at 4 weeks
0 weeks(baseline), 2 weeks, 4 weeks
Secondary Outcomes (2)
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
Study Arms (2)
Chinese herbal medicine
EXPERIMENTALIndividualized Treatment with Chinese herbal
Placebo
PLACEBO COMPARATORIndividualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai University of Traditional Chinese Medicinelead
- Longhua Hospitalcollaborator
- Shanghai Putuo District Center Hospitalcollaborator
Study Sites (1)
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201108, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kaixian Chen, Ph.D
Shanghai Universitu of TCM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
May 1, 2013
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
June 12, 2019
Record last verified: 2013-05