Effect of bamboo shavings (Phyllostachyos Caulis in Taeniam) extract on improvement of height growth

A 12-week, randomized, multi-center, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of bamboo shavings (Phyllostachyos Caulis in Taeniam) extract on improvement of height growth

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001714

Enrollment

Registered

2015-12-02

Start date

2015-10-21

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 : Consumption of bamboo shavings (Phyllostachyos Caulis in Taeniam) extract or placebo for 12 weeks (twice a day*3 capsule)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Children aged 6 to 11 years 2) Children before adolescence, 3~ 25 percentile based on 2007 standard growth chart percentile 3) A suitable people to apply the clinical trial subject through a physical examination, interview conducted in accordance with the study protocol 4) A suitable people to apply the clinical trial subject through a blood, urine test conducted in accordance with the study protocol 5) Spontaneously agreed to participate in the study by the patients and legal guardians or parents

Exclusion criteria

Exclusion criteria: 1) Children who have taken growth hormone within the last 6 month prior to the first visit of the study 2) Children who have growth retardation caused by endocrine disorders (growth hormone deficiency, hypothyroidism, type 1 diabetes mellitus etc.) 3) Children who have intrauterine growth retardation 4) Children who have taken functional foods (vitamin D, K, Ca) within the last 4 weeks prior to the baseline visit of the study for growth 5) Children who have taken drug (hyperlipidemia, endocrine system, endocrinotherapy) within the last 4 weeks prior to the baseline visit of the study for growth 6) Children with gastric disease or gastrointestinal surgery 7) Children with diseases as follows: hepatic diseases, pancreas diseases, renal diseases, nervous system diseases, respiratory system diseases, endocrine system diseases, hemato-oncology, mental illness, cardiovascular disease 8) Known hypersensitivity to study product or any ingredient in study product. 9) Children with following diseases - Aspartate transaminase(AST) or Alanine transaminase(ALT) = the upper limit of normal levels (ULN)?1.5 - Total bilirubin = the upper limit of normal levels (ULN)?1.5 - Serum creatinine= the upper limit of normal levels (ULN)?1.5 - Creatine kinase = the upper limit of normal levels ULN)?1.5 10) Hypertension (Systolic blood pressure(SBP)= 130 mmHg or Diastolic blood pressure(DBP) = 77 mmHg), pulse >100 11) Children who have taken ethical drug, oriental medicine within the last 4 weeks or over the counter drug within the last 2 weeks prior to the baseline visit of the study 12) Participation in other human study within 2 month prior to the first visit 13) Children with any other health concerns

Design outcomes

Primary

Measure	Time frame
Height ;IGF-1 (Insulin-like growth factor-1)	—

Secondary

Measure	Time frame
IGFBP-3(Insulin-Like Growth Factor-Binding Protein-3);Bone age(X-ray);Growth Hormone;Osteocalcin ;IGF-1/IGFBP-3 ratio	—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Ok Lee

Hallym University

Outcome results