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Construction of a Traditional Chinese Medicine treatment system for simple obesity based on a prospective multicenter clinical randomized controlled study of Fuer Bigu therapy

Construction of a Traditional Chinese Medicine treatment system for simple obesity based on a prospective multicenter clinical randomized controlled study of Fuer Bigu therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000777
Enrollment
Unknown
Registered
2024-12-08
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Simple obesity

Interventions

Treatment group:During the fasting period, the subjects took the traditional Chinese medicine formula for "JianPiTiaoGanYin" throughout the entire cycle and underwent lifestyle interventions.
Lifestyle interventions:Conduct cognitive education dietary planning and exercise guidance for the subjects.
Intermittent Fasting group:All study participants received energy restriction intervention, choosing to consume a diet of 400 kcal of energy for 2 consecutive days per week, and a healthy diet for the

Sponsors

The Fifth Peoples Hospital of Jinan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1)Meets the diagnostic criteria for simple obesity (Diagnostic criteria: Refer to the 2001 edition of "Brief Introduction to the Recommended Classification of Body Mass Index for Chinese Adults": Body Mass Index > 28 kg/m2 waist circumference = 85 cm for men waist circumference = 80 cm for women confirmed as simple obesity); 2). Age between 18 and 60 years both male and female; 3). First-time diagnosis of simple obesity; or previously diagnosed with simple obesity but not treated with weight-loss drugs or other weight-loss therapies; 4). Syndrome differentiation as liver depression and spleen deficiency type; 5). The patient signs the informed consent form themselves or it is signed by their immediate family member on their behalf; 6). Has a correct understanding of the significance of the study and good compliance with the observations and evaluations by the researchers.

Exclusion criteria

Exclusion criteria: 1).Age 60 years; 2). Patients with secondary obesity (such as those caused by hypothalamic syndrome pituitary tumors Cushing's syndrome hypogonadism etc.); patients with obesity induced by medication. 3). Those who are currently taking weight-loss drugs or have stopped other weight-loss methods for less than two weeks. 4). Patients with severe complications or primary diseases of the cardiovascular liver kidney digestive endocrine hematopoietic systems etc.; 5). Women who are pregnant breastfeeding or have plans to conceive within the next six months; 6). Patients with high levels of anxiety and depression (SAS=70 or SDS=70) and patients with psychiatric disorders; 7). Those who are currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
weight;

Secondary

MeasureTime frame
Thigh circumference;hip circumference;Abdominal circumference;body mass index;waistline;

Countries

China

Contacts

Public ContactHan Lulu

The Fifth Peoples Hospital of Jinan

hanlulu_hll@126.com+86 158 6525 9050

Outcome results

None listed

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