| Trial ID: | L4372 |
| Source ID: | NCT03010241
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| Associated Drug: |
Tangbi (Prescription)
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| Title: |
The Multi-Centric Clinical Study of Chinese Medicine Intervention on Diabetes Distal Symmetric Polyneuropathy.
|
| Acronym: |
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| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Tangbi (prescription)|DRUG: Placebo
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| Outcome Measures: |
Primary: The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication, Month 0, Month 3, Month 6 | Secondary: nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine., Month 0, Month 6|Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine., Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
|
| Sponsor/Collaborators: |
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Collaborators: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine|Zhengzhou City Hospital of Traditional Chinese Medicine|First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine|Hebei Yiling Hospital|Hubei Hospital of Traditional Chinese Medicine
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
EARLY_PHASE1
|
| Enrollment: |
188
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2017-01
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| Completion Date: |
2020-05
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| Results First Posted: |
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| Last Update Posted: |
2017-01-05
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT03010241
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