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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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12 December 2020 |
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Main ID: |
NCT03455049 |
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Date of registration:
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17/01/2018 |
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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 Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR
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Scientific title:
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The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject |
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Date of first enrolment:
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October 17, 2017 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03455049 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Tri Juli Edi Tarigan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fakultas Kedokteran Universitas Indonesia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18 year old until 60 year old
2. Normal glucose tolerance subject or prediabetes
3. The kidney function (creatinine) and liver function (SGPT) in range normal
4. Subject has signed agreement (informed consent)
Exclusion Criteria:
1. Pregnant
2. Feeding baby
3. Subject has comorbide or chronic disease uncontrolled
4. Subject has cancer
5. Subject consume medication influenced blood glucose such as steroid an suplement
6. Insulin dependent diabetes
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Increased Insulin
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Intervention(s)
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Other: Andrographis Paniculata Ext
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Primary Outcome(s)
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GLP-1
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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Secondary Outcome(s)
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Glycated Albumin
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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2h-OGTT plasma glucose level
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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Fasting Insulin
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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HOMA-IR
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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Dypeptidil Peptidase 4 (DPP-4) Enzyme
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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Fasting plasma glucose level
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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2h-OGTT Insulin
[Time Frame: A measure assesing change from baseline GLP-1 at 14 days.]
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Secondary ID(s)
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IndonesiaU-02
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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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