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Randomized, Double-blind, and Placebo-controlled a Clinical Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract : Study Protocol

Randomized, Double-blind, and Placebo-controlled a Clinical Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004408
Enrollment
100
Registered
2019-10-31
Start date
2019-05-29
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Ferment oyster group will take 500mg of ferment oyster extract, once a day, before sleep, for 6 months. Placebo group will take 3400mg of fructooligosaccharide as placebo, once a

Sponsors

Pusan National University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
height growth

Secondary

MeasureTime frame
growth speed, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH

Countries

Korea, Republic of

Contacts

Public ContactHee-Yeon Kim

Pusan National University Korean Medicine Hospital

kimhy1872@daum.net+82-55-360-5575

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026