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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: |
NCT02752880 |
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Date of registration:
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26/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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YH1 in Poorly Controlled Type 2 Diabetes
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Scientific title:
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The Efficacy and Safety of Concentrated Herbal Extract Granules, YH1, as an Add-On Medication in Poorly Controlled Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02752880 |
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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: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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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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Yueh-Hsiang Huang, 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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Chang Gung Memorial Hospital, Taoyuan, Taiwan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 20-75 years of age;
2. Diagnosed as type 2 diabetics based on World Health Organization criteria [1];
3. Body mass index (BMI) = 23 kg/m2;
4. Have been treated with = 3 kinds of oral hypoglycemic agents (OHAs) with persistent (>
6 months) high HbA1c (= 7.0 %).
Exclusion Criteria:
1. Type 1 diabetes, gestational diabetes, or other specific types of diabetes;
2. Have received insulin therapy in the past three months;
3. Have serious gastrointestinal (GI) tract diseases, such as peptic ulcers or GI tract
bleeding;
4. Experience stressful situations, including diabetic ketoacidosis, nonketotic
hyperosmolar diabetic coma, severe infection, or surgery in the previous one month;
5. Suffer from hepatic insufficiency with alanine aminotransferase (ALT) 2 times the
upper limit of normal or renal insufficiency with estimated glomerular filtration rate
(eGFR) < 60;
6. Uncontrolled hypertension (blood pressure = 160/100 mmHg);
7. Mental illness, abused or addicted to alcohol, psychoactive substances or other drugs;
8. Pregnant, lactating, or plan to become pregnant;
9. Hemoglobin disease or chronic anemia;
10. Have underlying conditions that could lead to poor compliance;
11. History of cerebrovascular disease or myocardial infarction;
12. Have undergone Chinese medicine treatment in the past two weeks.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: YH1 group
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Drug: placebo group
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Primary Outcome(s)
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The Percentage Change in HbA1c Level From Baseline to 12 Weeks
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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The Percentage Change in 2hPG From Baseline to Week 12
[Time Frame: 12 weeks]
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Secondary ID(s)
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104-7934A3,105-7009C,106-0917C
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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