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Efficacy and safety of Shi-Wei-Jian-Fei Recipe in the treatment of obesity: a multicenter, double-blind, randomized placebo-controlled trial

Clinical study of Shi-Wei-Jian-Fei Recipe in the treatment of Obesity

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074260
Enrollment
Unknown
Registered
2023-08-02
Start date
2023-08-05
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Test group:Shi-Wei-Jian-Fei Recipe
Control group:Placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine, Zhuhai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1.BMI:28-40kg/m 2; 2.Aged 18-64 years; 3.Able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Simple diet control and increased exercise therapy in the first 3 to 6 months. Weight loss >= 5%; 2. In the past 3 months, he has taken treatment that affects body weight (including sedatives, antidepressants, steroids and hormones, etc.) or participated in other weight loss programs (such as diet restriction, physical training, etc.); 3. Plan to move out of the area within 1 year; 4. Have undergone weight loss surgery in the past or planned weight loss surgery within 1 year; 5. Have a history of suicidal behavior or have been diagnosed with eating disorders (bulimia, Anorexia); 6. History of hospitalization or substance abuse due to mental illness; 7. Active cancer; 8. Severe arrhythmia or cardiomyopathy, severe congestive heart failure, stroke or heart attack in the past six months; 9. Chronic inflammatory disease. Including, but not limited to, severe arthritis, lupus or inflammatory bowel diseases (i.e. Crohn's disease or ulcerative colitis); 10. Life-threatening diseases, or diseases that can be aggravated by exercise or weight loss; 11. Secondary obesity: hypothalamus disease, anterior pituitary dysfunction, etc.; 12. Pregnant, lactating women or preparing to become pregnant within one year.

Design outcomes

Primary

MeasureTime frame
Body weight;

Secondary

MeasureTime frame
body mass index (BMI);Waist circumference;Hip circumference;Waist-hip ratio;Body fat percentage;Systolic blood pressure;Diastolic pressure;Glycosylated hemoglobin(HbA1c);Fasting blood glucose;Four items of blood lipid;C-reactive protein;Constitution in Chinese Medicine Questionnaires(CCMQ);Impact of Weight on Quality of Life–Lite(IWQOL-Lite));Intestinal flora;Lean body weight;Fasting C-peptide;Serum insulin;Routine semen testing;Insulin resistance;Six items of sexual hormones;Gynecological B-ultrasound;

Countries

China

Contacts

Public ContactXie Changcai

Guangdong Provincial Hospital of Chinese Medicine, Zhuhai

hxie114@163.com+86 136 5099 7551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026