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Evaluation of the Clinical Efficacy of Jianpi Huashi Granules in Treating Overweight and Obese Patients and Multi-Omics Studies

Evaluation of Clinical Efficacy and Mechanism of Jianpi Huashi Granules in the Treatment of Patients with Metabolic Syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002139
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Overweight and Obesity

Interventions

Control Group:Healthy Lifestyle Intervention Plus Placebo of Jianpi Huashi Granules
Intervention Group:Healthy Lifestyle Intervention Plus Jianpi Huashi Granules

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with a BMI of 24 kg/m² to 32.5 kg/m² who are diagnosed with the syndrome of spleen deficiency and damp-heat in Traditional Chinese Medicine. (2) Patients aged between 20 and 75 years old.

Exclusion criteria

Exclusion criteria: (1) Patients with glycated hemoglobin (HbA1c) > 9% who have been diagnosed with diabetes mellitus and are currently using medications for control. (2) Pregnant or breastfeeding women. (3) Patients with severe complications of the heart liver or kidneys or with abnormal liver or kidney function (e.g. liver enzymes more than 3 times the upper limit of normal estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73m²) or those with other severe primary diseases or psychiatric conditions. (4) Patients who are allergic to any of the medications in the treatment regimen or who are not suitable for this treatment plan. (5) Patients who have used traditional Chinese medicine or patent Chinese medicines within the past 3 months or who have participated in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Efficacy rate of achieving a 15% weight reduction within 1 year;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Score;Hip circumference;Waist circumference;Health Status Questionnaire;Weight;Body Mass Index;Homeostatic Model Assessment of Insulin Resistance;Fasting blood glucose;Fasting insulin;Glycated hemoglobin;Total cholesterol;Triglycerides;High-density lipoprotein;Low-density lipoprotein;

Countries

China

Contacts

Public Contactluhao

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

luhao403@163.com13916719260

Outcome results

None listed

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