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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT02855645 |
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Date of registration:
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21/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Trichosanthes Root on Blood Sugar in Patients With Diabetes Mellitus
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Scientific title:
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Date of first enrolment:
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July 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02855645 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Ching-Liang Hsieh, M.D. , Ph.D |
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Address:
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Telephone:
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+886-4-22053366 |
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Email:
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clhsieh@mail.cmuh.org.tw |
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Affiliation:
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Name:
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Ching-Liang Hsieh |
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Address:
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Telephone:
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Email:
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Affiliation:
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China Medical University Hospital |
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Name:
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Ching-Liang Hsieh, professor |
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Address:
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Telephone:
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+886-4-22053366 |
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Email:
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clhsieh@mail.cmuh.org.tw |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Early diagnosis Type ? Diabetic patients who Glycated hemoglobin A1c level between
7.0% and 9.0% (including) , and after three months of diet and exercise control.
2. The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of
? 1500 mg / day.
3. Age ranged between 20 and 80 years (including).
Exclusion Criteria:
1. Pregnancy or breast-finding.
2. Allergy to test medicine.
3. Type I Diabetic patients.
4. Bleeding tendency.
5. The participants who suffered from serious disorders, such as congestive heart
failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure,
cancer or stroke etc.
6. Irritable or anxious patients who cannot be assessed.
7. Refuse to sign the agreement.
8. The values of SGOT and SGPT levels were more than normal limit triple, or the value
of creatinine level was more than normal limit.
9. Plasm glucose(Glucose AC) level in fasting state ? 300 mg / dL.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Drug: Placebo
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Drug: Trichosanthes root
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Primary Outcome(s)
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Glycated hemoglobin A1c
[Time Frame: Three months]
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Plasma Blood Sugar
[Time Frame: Three months]
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Secondary ID(s)
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CMUH105-REC2-052
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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