Peking University third hospital
Beijing, China
NCT Number: NCT06306417
To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Beijing, China
A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lifestyle intervention
acupuncture
Sham acupuncture
Time frame: baseline and after 4 months
calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)
[Time Frame: Baseline]
Time frame: baseline and after 4 months
general condition
Time frame: baseline and after 4 months
during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after treatment
testosterone (nmol/ml) ×100 / SHBG (nmol/ml).
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry).
Time frame: baseline and after 4 months
gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000.
Time frame: baseline and after 4 months
determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better
Time frame: baseline and after 4 months
determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.
Time frame: baseline and after 4 months
determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse
Time frame: baseline and after 4 months
Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS
Time frame: baseline and after 4 months
calculation:BMI=weight(kg)/height(m)^2
Time frame: baseline and after 4 months
examined by body composition analyzer
Time frame: baseline and after 4 months
calculation of WHR: waist circumference(cm)/ hip circumference(cm)
Time frame: baseline and after 4 months
Examined with the blood sample
Time frame: baseline and after 4 months
baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm)
Time frame: baseline and after 4 months
observed by B-ultrasound
Time frame: baseline and after 4 months
observed by B-ultrasound
Time frame: baseline and after 4 months
observed by B-ultrasound
Peking University Third Hospital
Other
Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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