Simple overweight population with spleen deficiency and dampness-excess pattern (Pi-Xu Shi Sheng)?
Conditions
Interventions
Test Group:Take Lightweight Little Gold TM Red Adzuki Bean Coix Seed Poria Cocos Paste
Sponsors
The Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years, gender unrestricted; (2) Overweight or mild obesity (BMI: 24.0–32.5 kg/m²) OR? body fat percentage >25% (male) or >30% (female); (3) Meet the TCM diagnostic criteria for ?spleen deficiency-dampness pattern (Pi-Xu Shi Sheng)? per Expert Consensus on TCM Diagnosis and Treatment of Obesity (Appendix 1); (4) Fluent in Chinese, capable of understanding trial procedures, and voluntarily signed informed consent; (5) Able to attend follow-ups, report health changes/adverse effects, and adhere to study requirements.
Exclusion criteria
Exclusion criteria: (1) History of severe cardiac, hepatic, pulmonary, renal, hematologic, or neoplastic diseases; (2) Participants with uncontrolled major psychiatric conditions exhibiting behavioral dysregulation and non-compliance.? (3) Subjects with organic digestive system lesions identified through examination, such as peptic ulcers, erosions, gastric mucosal lesions, or suspected malignancy; those with concurrent pancreatic or biliary tract disorders; or individuals with a history of intra-abdominal surgery; (4) Concurrent functional gastrointestinal disorders (FGIDs); (5) Subjects who have used functional health products or medications related to the study's objectives within the past month, which may interfere with outcome assessment; (6) Other conditions that may cause gastrointestinal symptoms: including a history of alcohol/drug dependence or abuse; (7) ?Individuals with allergies to the test product or a history of hypersensitivity; (8) Pregnant women, women planning pregnancy, or lactating women; (9) Individuals deemed ineligible for participation by the investigator or those at high risk of being lost to follow-up.?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score Scale (TCMSS);PRO Scale for Spleen-Stomach Disorders;TCM Dampness Syndrome Assessment Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Composition Analysis;Life signs (blood pressure, pulse, body temperature); | — |
Countries
China
Contacts
Public ContactHu Jiang
The Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Outcome results
None listed