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Observation of the Efficacy of Modified Cangfu Daotan Decoction Combined with Acupuncture in Treating Polycystic Ovary Syndrome of Spleen Deficiency and Phlegm-Dampness Type

Observation of the Efficacy of Modified Cangfu Daotan Decoction Combined with Acupuncture in Treating Polycystic Ovary Syndrome of Spleen Deficiency and Phlegm-Dampness Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000489
Enrollment
Unknown
Registered
2026-03-10
Start date
2023-12-05
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

Polycystic ovary syndrome

Interventions

Conventional medication group:Metformin hydrochloride + Drospirenone and ethinylestradiol tablets
Combined traditional Chinese medicine group:Metformin hydrochloride + Drospirenone and ethinylestradiol tablets + Modified Cangfu Daotan Decoction + Acupuncture

Sponsors

Shanxi Provincial Children's Hospital (Shanxi Provincial Maternal and Child Health Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meets the Western medicine diagnostic criteria for polycystic ovary syndrome (PCOS), referencing the "Chinese Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome": The patient exhibits infrequent or absent ovulation, hyperandrogenism, and polycystic ovarian changes. 2. Meets the traditional Chinese medicine (TCM) diagnostic criteria for spleen deficiency and phlegm-dampness type PCOS, referencing "Traditional Chinese Medicine Gynecology": Main symptoms - amenorrhea, scanty menstruation, and obesity; Secondary symptoms - dizziness, fatigue, abdominal distension, and loose stools; Tongue and pulse - pale and swollen tongue with white, greasy coating and slippery pulse. The patient can be diagnosed if they meet 3 main symptoms + 2 secondary symptoms + tongue and pulse characteristics. 3. Age between 20 and 40 years old; 4. Has not received other drug or TCM treatments for PCOS in the past 3 months; 5. Able to tolerate conventional Western medicine, Cangfu Daotan Decoction with modifications, and acupuncture treatment, with good compliance; 6. The patient and their family are fully informed and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to the Western medicine, traditional Chinese medicine (including the modified Cangfu Daotan Decoction formula components), or acupuncture materials used in this study; 2. Individuals participating in other clinical studies; 3. Individuals with mental illness, cognitive impairment, or other conditions that prevent them from cooperating with treatment and data collection; 4. Individuals with severe underlying diseases of the heart, liver, kidneys, or endocrine system, or with malignant tumors or hematological diseases; 5. Pregnant or breastfeeding women; 6. Individuals with contraindications to acupuncture treatment (such as coagulation disorders, skin infections, etc.).

Design outcomes

Primary

MeasureTime frame
Overall treatment effectiveness rate;

Secondary

MeasureTime frame
Incidence of adverse reactions;Traditional Chinese Medicine symptom score;Sex hormone levels;Waist-to-hip ratio and body mass index;Hyperandrogenism symptom score;

Countries

China

Contacts

Public ContactKang Lirong

Shanxi Provincial Children's Hospital (Shanxi Provincial Maternal and Child Health Hospital)

klr8044@163.com13934203152

Outcome results

None listed

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