Randomized, Double-blind, and Placebo-controlled a Clinical Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract : Study Protocol
- Conditions
- Not Applicable
- Registration Number
- KCT0004408
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 100
(1) Children up to the 25th percentile by age and gender for the 2017 standard growth chart percentile by idiopathic
(2) After fully hearing and understanding the details of this clinical trial, you agree to participate voluntarily and agree in writing to abide by the instructions
(1) Those who have a growth delay due to endocrine diseases (growth hormone deficiency, hypothyroidism, type 1 diabetes, etc.)
(2) Those who have precocious puberty (female Tanner stage II under 8 years old, Testicular size Tanner stage II under 9 years old)
(3) A person who is being treated for the manifestation of a serious infectious disease or a tumor.
(4) Those who received growth hormone within 4 weeks prior to visit 1
(5) Those who have taken medicines and health foods aimed at improving kidney growth within two weeks prior to visit 1
(6) diabetic patients with uncontrolled blood glucose (when fasting glucose is above 126 mg / dL or when typical symptoms of diabetes (polyuria, then unexplained weight loss and any blood sugar over 200 mg / dL))
(7) Those whose TSH, T3, and FT4 test values ??deviate from the normal values ??of the research institute
(8) Those who have abnormal renal function that is more than twice the normal upper limit of each Creatinine organ
(9) A person with abnormal liver function that is more than twice the normal upper limit of each AST (GOT) or ALT (GPT) organ.
(10) Those who are currently being treated for severe heart disease such as congenital heart disease
(11) A person who plans to participate in other tests during this human application test.
(12) those who are taking methylphenidate drugs with ADHD
(13) Allergic to shellfish
(14) The person in charge judges that it is not suitable for other tests.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method height growth
- Secondary Outcome Measures
Name Time Method growth speed, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH