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

Phase 1

• Conditions: polycystic ovary syndrome

• Registration Number: ITMCTR2100004718
• Lead Sponsor: Beijing Chinese medicine hospital affiliated capital medical university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified