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

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0001714
• Lead Sponsor: Korea Medicine Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Height ;IGF-1 (Insulin-like growth factor-1)

Secondary Outcome Measures

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