A 6 month, multi-center, randomized, double-blind, placebo-controlled parallel design human study for the evaluation of the efficacy and safety of HT042 on height promoting in low-height children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000736

Enrollment

140

Registered

2013-05-02

Start date

2013-07-15

Completion date

Unknown

Last updated

2019-03-11

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 : HT042 group: The main ingredient is the complex of Phlomis umbrosa extract, liq., 2 packs a day after meal. Placebo group: The main ingredient is Fructo-oligosaccharides and Puri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 6 to 8 years 2) children less than 25 percentile based on 2007 standard growth chart percentile due to idiopathic 3) People who signed the informed consent form before participating in the study

Exclusion criteria

Exclusion criteria: 1)Children have Growth retardation caused by endocrine disorders (Growth Hormone deficiency, Hypothyroidism, type 1 diabetes mellitus etc.) 2)Children have Precocious Puberty(LH > 0.6 IU/L) 3)Children being treated with infected, tumor etc. 4)Children who have taken growth hormone within the last 4 weeks prior to the first visit of the study 5)Children who have taken functional foods or drugs within the last 2 weeks prior to the first visit of the study for growth 6)Patient has uncontrollable type 1 diabetes mellitus(Fasting blood glucose levels greater than 126 mg/dl) 7)TSH, T3, FT4 deviates from the normal value of the hospital 8)Patient has creatinine value exceeding 2 times of upper limit of the normal range at the hospital 9)Patient has AST(GOT) or ALT(GPT) value exceeding 2 times of upper limit of the normal range at the hospital 10)Subjects who are scheduled for another study during this study period 11)Subjects with any other health concerns

Design outcomes

Primary

Measure	Time frame
Height	—

Secondary

Measure	Time frame
Rate of growth;Height Standard Deviation Score(z-score);Bone age(X-ray);Growth Hormone;IGF-1(Insulin-Like Growth Factor-1, somatomedin C);GFBP-3(Insulin-Like Growth Factor-Binding Protein-3);Osteocalcin;1CTP(Cross-linked C-terminal telopeptide of type I collagen);BALP(Bone Alkaline Phosphatase);DPD(Urine Deoxypyridinoline)	—

Countries

Korea, Republic of

Contacts

Public ContactPark Seul Ki

Kyung Hee University Oriental Medicine Hospital at Gangdong

Outcome results