Weightless bone loss
Conditions
Interventions
experimental group:Oral (containing chemical), 1 bag of anti-blight cream, 2 times a day. The medication was given once after breakfast and once after dinner. The interval between the two doses was at
placebo group:Oral (containing chemical), 1 bag of anti-blight cream mimic twice a day. The medication was given once after breakfast and once after dinner. The interval between the two doses was at l
Sponsors
The First Affiliated Hospital of PLA Navy Medical University (Changhai Hospital,Shanghai )
Eligibility
Sex/Gender
Male
Age
25 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1 Male, 25 years old = age =50 years old, 160 cm= height =175 cm, high school education (including) or above. 2 Weight =50 kg, 18.5 kg/m2=BMI=26 kg/m2 [BMI= weight (kg)/Height 2(m2)]. 3 Normal bone mineral density (Z-value > -2.0SD), 25 hydroxyvitamin D=20 ng/mL. 4 Physical and mental health, with good psychological quality and willpower, no infectious diseases, normal medical examination or mild abnormalities have no clinical significance. 5. Volunteer to participate in this clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1 The researcher himself or herself, the relevant staff of the research center and their family members. 2 Participated in any drug and medical device clinical trials within 3 months prior to screening. 3 People who are allergic to any food or drug, or to known ingredients of the investigational drug (icariin, naringin, potassium sorbate, xylitol). 4 Clinical findings indicate the following diseases of clinical significance: including but not limited to bone trauma, skeletal metabolic diseases, gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, cardiovascular and cerebrovascular, psychiatric or psychological diseases. 5 Abnormal laboratory detection indicators and clinical significance. 6 Have special food requirements and are unwilling or unable to complete a diet control plan during the study. 7 Those who plan to have children in the next 6 months and do not wish to use effective contraception. 8 Patients with a history of drug use or positive urine drug screening. 9 Positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or syphilis specific antibody (TP-Ab) at screening. 10 Donated blood within 1 month prior to screening or donated more than 450mL within 3 months prior to screening. 11 A history of alcohol abuse [greater than 21 units per week (men) (1 unit =360mL beer; or 150 ml wine; or 45mL liquor)], or subjects unwilling to stop drinking from the date of signing the informed consent to the end of the study, or positive for alcohol breath tests upon admission. 12 Smoking more than 5 cigarettes per day in the 3 months prior to the trial, or failing to comply with the no-smoking policy during the trial period. 13 Have drug dependence, or have taken drugs that affect bone metabolism within two weeks prior to screening. 14 Persons with metal implants. 15 Patients with severe vertigo and severe snoring. 16 Recent marriage setbacks, family changes. 17 Have a criminal record (if you pass the primary, you need to submit a certificate of no criminal record according to the notice). 18 Other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar spine (L1-L4) bone density;Distal tibial bone mineral parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hip bone density;Calcaneal bone density;Bone metabolic biomarkers for bone formation;Bone metabolic biomarkers for bone resorption;25 hydroxyvitamin D;blood calcium;serium inorganic phosphorus;Creatine Kinase Isoenzyme;blood lactic acid;Middle leg muscle cross-section area;Muscle circumference of lower extremity;Cross-sectional area and apparent diffusion coefficient of calf and psoas major muscle ;Muscle strength of lower limb;Lower extremity electromyogram;Lying height;Decumbent weight;Body fat weight and percentage;Body moisture weight and percentage;Intracellular fluid volume and percentage;Extracellular fluid volume and percentage; | — |
Countries
China
Contacts
Public ContactLi Zhang
Shanghai Changhai Hospital
Outcome results
None listed