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A clinical randomized controlled study on the treatment of overweight and obese polycystic ovary syndrome with fire acupuncture of invigorating spleen and kidney

A clinical randomized controlled study on the treatment of overweight and obese polycystic ovary syndrome with fire acupuncture of invigorating spleen and kidney

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004718
Enrollment
Unknown
Registered
2021-04-09
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

polycystic ovary syndrome

Interventions

control group:Lifestyle intervention
treatment group:fire acupuncture of invigorating spleen and kidney+Lifestyle intervention

Sponsors

Beijing Chinese medicine hospital affiliated capital medical university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for PCOS in Rotterdam (2003): ?sporadic ovulation or anovulation; ?hyperandrogenemia and/or hyperandrogenic clinical manifestations (e.g., hirsutism, acne, etc.); ?B-ultrasound showed polycystic ovarian changes. (2) Meet the diagnostic criteria of traditional Chinese medicine: refer to the "Guidelines for Clinical Research on New Chinese Medicines" requirements: ? amenorrhea or late menstruation. ?Dizziness and tinnitus, soreness and weakness of the waist and knees, obesity, excessive amount of hypogonadism, facial acne, dense hair, constipation, breast distension and pain. (?) Distension and pain in the abdomen. Poor menstruation. (4) Pale and dull tongue with white or yellowish coating. ? Fine and sunken pulse. (3)BMI = 25 kg/m2. (4) Age between 18 and 40 years old; (5) Able to understand and complete the required scale tests. (6) Voluntarily participate in the trial and sign the informed consent form. All of the above conditions must be met in order to be included in this trial.

Exclusion criteria

Exclusion criteria: (1) Other diseases known to cause hyperandrogenism or ovulation disorders (exclude patients with congenital adrenocortical hyperplasia, androgen-secreting tumors, Cushing's syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, early-onset ovarian insufficiency, etc.) (2) Patients with combined severe cardiac, hepatic, or renal insufficiency or organic pathology or severe gynecological disease (3) Those who have received medication (cortisol, other glucose-lowering treatments such as insulin, acarbose, antidepressants, hormonal contraceptives, hormonal ovulatory drugs or other drugs) in the last 3 months (4) Those who cannot tolerate fire-acupuncture treatment or cannot cooperate with the examination and treatment. (5) Pregnant and lactating women. Those who meet one of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
LH/FSH;

Secondary

MeasureTime frame
Prolactin;Ferriman-Gallwey;Quality of life questionnaire score for polycystic ovary syndrome;Follicle stimulating hormone;Endometrial thickness;self-rating depression scale;estradiol;Low density lipoprotein cholesterol;Ovarian volume;Total cholesterol;HOMA-IR;Body Mass Index;luteinizing hormone;self-rating anxiety scale;testosterone;Follicle number;High density lipoprotein cholesterol;progesterone;triglyceride;

Countries

China

Contacts

Public ContactJing Guo
guojing_2002@163.com13651119255

Outcome results

None listed

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