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Observation on the Clinical Efficacy of Banxia Xiexin Decoction Combined with Acupoint Catgut Embedding in Treating PCOS-IR Patients with Stomach Heat-Spleen Deficiency Pattern in the Lingnan Region

Observation on the Clinical Efficacy of Banxia Xiexin Decoction Combined with Acupoint Catgut Embedding in Treating PCOS-IR Patients with Stomach Heat-Spleen Deficiency Pattern in the Lingnan Region

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000468
Enrollment
Unknown
Registered
2026-03-05
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Insulin Resistance in Polycystic Ovary Syndrome(PCOS-IR)

Interventions

Western medicine combined with traditional Chinese medicine group (metformin combined with Banxia Xiexin Decoction):Oral administration of metformin: 1) Drug selection: Plastic bottle packaging, speci
continuous medication for 12 weeks. Traditional Chinese Medicine: Modified Banxia Xiexin Decoction (Rhizoma Pinelliae 9 g, Rhizoma Coptidis 3 g, Radix Scutellariae 9 g, Rhizoma Zingiberis 3 g, Radix G
The combination of traditional Chinese and western medicine plus acupoint catgut embedding group:Oral administration of metformin:1) Drug selection: Plastic bottle packaging, specification: 25 mg, 100
continuous administration for 12 weeks. Traditional Chinese medicine: Modified Banxia Xiexin Decoction(Rhizoma Pinelliae 9 g, Rhizoma Coptidis 3 g, Radix Scutellariae 9 g, Rhizoma Zingiberis Recens 3

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityShenshan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for PCOS and insulin resistance (IR);2) Meet the syndrome differentiation criteria for stomach heat and spleen deficiency;3) Aged 18–35 years;4) Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients who have used hormones (except progesterone) and other drugs affecting reproductive endocrinology within the past 3 months;2) Patients with severe diseases such as hematological diseases, cardiovascular and cerebrovascular diseases, and thrombotic diseases;3) Patients with mental illness or cancer;4) Patients with other endocrine diseases (e.g., adrenal diseases, diabetes, or thyroid diseases);5) Patients with malabsorption syndrome or other digestive system diseases;6) Patients with alcoholism and/or drug or psychoactive substance abuse;7) Patients with a history of severe allergy to traditional Chinese medicine or adhesive tape;8) Patients within 2 years after menarche.

Design outcomes

Primary

MeasureTime frame
Insulin Resistance Index;

Secondary

MeasureTime frame
Sex hormones in women;Body Mass Index(BMI);Score of Traditional Chinese Medicine (TCM) Symptoms;

Countries

China

Contacts

Public ContactYue Cai

Department of Traditional Chinese MedicineSun Yat-sen Memorial Hospital, Sun Yat-sen

1052914542@qq.com15014162495

Outcome results

None listed

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