Overweight or obese
Conditions
Interventions
High dose REDOX group:High dose Ruijian BID (3.0g)
Low dose Rui Jian group:Low dose Ruijian BID (1.5g)
High-dose placebo group:Placebo BID (3g)
Low dose placebo group:Placebo BID (1.5g)
Sponsors
Children's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Male or female =12 years old and < 18 years old at the time of signing the informed consent; 2. According to the guidelines, adolescents are clinically defined as overweight or obese (overweight is the 85th percentile < 95th percentile of BMI= the same age and gender reference average, obesity is the 95th percentile of BMI= the same age and gender reference average); 3. Subject and guardian sign informed consent to participate in the study; 4. Willingness to communicate with investigators, ability to understand and follow trial requirements, and willingness and ability to comply with visit schedules, product administration schedules, laboratory examinations, and other clinical trial procedures.
Exclusion criteria
Exclusion criteria: 1. People who are known to have a history of allergy to Ruijian and any of its components or related preparations. 2. Weight change of more than 5 kg in the 3 months prior to screening. 3. Use of any weight-loss drugs or products in the 3 months prior to screening. 4. Participated in any weight loss or diet control program in the 3 months prior to screening. 5. Systemic glucocorticoids (excluding topical applications or inhalants) or psychotropic drugs, antihypertensive drugs, hypoglycemic drugs and other drugs that may cause weight gain or loss within 3 months prior to screening. 6. Participants who have participated in other drug clinical trials and used experimental drugs within 3 months before screening. 7. History of gastrointestinal disease or surgery, including intestinal obstruction, intestinal ulcers, weight loss or band surgery, gastroenterostomy, and intestinal resection. 8. People with a history of eating disorders, including but not limited to anorexia, hypereating disorder, etc. 9. Any digestive diseases, including but not limited to chronic diarrhea, gastroparesis, gastroesophageal reflux disease, Crohn's disease, ulcerative colitis, pancreatitis, gastrointestinal perforation, severe intestinal obstruction, etc. 10. Patients with serious diseases of central nervous system, cardiovascular system, respiratory system, urinary system, blood system, metabolic system, etc., who have been assessed by researchers as not suitable for clinical trials. 11. Subjects with diabetes (type 1 or type 2 diabetes). 12. Subjects with secondary obesity (genetic, single gene mutation, drug, endocrine, etc.). 13. Known or suspected smokers, alcoholics or drug users. 14. There are other factors that the researcher considers unsuitable for participation in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI from baseline at week 12 (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline at week 12 (values and percentages);Change in BMI from baseline at week 12;Percentage of subjects with a BMI decrease of more than 3% from baseline at week 12 (%);Percentage of subjects with a BMI decrease of more than 5% from baseline at week 12 (%);Change in blood pressure from baseline at week 12 (mmHg);Changes in blood lipids from baseline at week 12 (TC, LDL, HDL, TG);;Changes in fasting blood glucose (mmol/L) and insulin (mU/L) from baseline at week 12 ;Changes in waist and hip circumference (cm) from baseline at week 12;Changes in waist circumference and hip circumference (cm) from baseline at week 12 Adverse events, serious adverse events, changes in vital signs, physical examinations, and laboratory tests from baseline at week 12. ; | — |
Countries
China
Contacts
Public ContactFu Junfen
Children's Hospital, Zhejiang University School of Medicine
Outcome results
None listed