PCOSPCOSNCT04193371
Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )
A study testing Active acupuncture and Lifestyle management in people with PCOS and Overweight, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS, Overweight, Obesity
- What is being tested?
- Active acupuncture and Lifestyle management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 40 years
- BMI≥ 24 to <40
- PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL.
- Controls should have BMI>25to<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound
Who cannot join
- Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
- Type I diabetes or not well controlled type II diabetes
- Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
- Pregnancy or breastfeeding the last 6 months
- Acupuncture last 3 months
- Daily smoking and alcoholic intake
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China
This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.
Read the detailed description
Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is ~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.
- Conditions
- PCOS, Overweight, Obesity
- Being tested
- Active acupuncture, Sham acupuncture, Lifestyle management
- Keywords
- PCOS, Overweight, Obesity, Acupuncture, Lifestyle management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active acupunctureOther
The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.
Sham acupunctureOther
In the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.
Lifestyle managementOther
All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).
All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.
| Study group | Role | What they receive |
|---|---|---|
| active acupuncture + lifestyle management | Experimental | Participants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment. Receives: Other: Active acupuncture; Other: Lifestyle management |
| control acupuncture + lifestyle management | Sham comparator | Participants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment. Receives: Other: Sham acupuncture; Other: Lifestyle management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
PCOS's weight in kilograms divided by the square of her height in meters, reported in kg/m2
Measured: After 4 months of intervention;
Secondary outcomes (42)
total body fat
examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
body fat and lean ratio
examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
visceral fat
examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
basal metabolic rate
examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
antral follicle count
examined the ovarian morphology with the B-ultrasound
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
sex hormone binding globulin (SHBG)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
anti-mullerian hormone (AMH)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
follicle stimulating hormone (FSH)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
luteinizing hormone (LH)
examined with the blood sample
Measured: After 4 months of intervention Follow-up 4 months after last treatment.,
Progestin (P)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Estrogen (E2)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Androgen(T)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Androstenedione (A2)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
HOMA-IR
will be assessed during the oral glucose tolerance test (OGTT) , calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
HOMA- β
will be assessed during the oral glucose tolerance test (OGTT) ,calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
glycated hemoglobin ( HbA1c)
The insulin and glucose response in blood
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
total cholesterol
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
triglycerides
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
high density lipoprotein (HDL)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
low density lipoprotein (LDL)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
lipometabonomic/lipidomics
Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
bile acid omics
Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
β-endorphin
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
5- hydroxytryptamine (5-HT)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
FerrimanGallwey (FG )value
To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
short form-36 (SF36)
determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
EuroQol health index scale (EQ-5D)
determine the health quality of life by the questionnaire of EQ-5D (0-100 score), the higher, the better.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
polycystic ovary syndrome questionnaire (PCOSQ);
determine the Effects of PCOS specific symptoms on the participants by the questionnaire of and polycystic ovary syndrome questionnaire (PCOSQ)(26-182 score); the higher, the better.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Self-Rating Anxiety Scale (SAS)
determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Self-Rating Depress Scale (SDS)
determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse.
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Body mass index (BMI)
Weight in kilograms divided by the square of her height in meters, reported in kg/m2
Measured: Follow-up 4 months after last treatment.
Fibroblast growth factor 19(FGF-19)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Ghrelin
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 6( IL-6 )
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 8( IL-8 )
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 22( IL-22 )
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Tumor Necrosis Factor-Alpha (TNF-α)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Gamma-Amino Butyric Acid(GABA)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
dopamine(DA)
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
Glutamate
examined with the blood sample
Measured: After 4 months of intervention, Follow-up 4 months after last treatment.
proteomics
Detection with the Proteomic techniques in blood, the sample size is about 30 participants in each group.
Measured: After 4 months of intervention
branched-chain amino acids
examined with the blood sample, the sample size is about 30 participants in each group.
Measured: After 4 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start6 Dec 2019
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cross-sectional case-control part and an open-labelled RCT with a comparative effectiveness design. The inter-ventions to be tested are (1) acupuncture during 4 months+lifestylemanagement; (3) sham acupuncture+lifestyle management
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- haolin zhang, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193371
- Sponsor's protocol ID
- PekingUTH TCM
- Acronym
- PCOS
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2019
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China
- ClinicalTrials.gov ID
- NCT04193371
- Acronym / sponsor ID
- PCOS / PekingUTH TCM
- Conditions
- PCOS, Overweight, Obesity
- Keywords
- PCOS, Overweight, Obesity, Acupuncture, Lifestyle management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.
Detailed description
Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is ~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cross-sectional case-control part and an open-labelled RCT with a comparative effectiveness design. The inter-ventions to be tested are (1) acupuncture during 4 months+lifestylemanagement; (3) sham acupuncture+lifestyle management
| Arm | Type | Receives |
|---|---|---|
| active acupuncture + lifestyle management | Experimental | Other: Active acupuncture, Other: Lifestyle managementParticipants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment. |
| control acupuncture + lifestyle management | Sham comparator | Other: Sham acupuncture, Other: Lifestyle managementParticipants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 40 years
- BMI≥ 24 to <40
- PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL.
- Controls should have BMI>25to<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound
Key exclusion criteria (6 listed)
- Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
- Type I diabetes or not well controlled type II diabetes
- Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
- Pregnancy or breastfeeding the last 6 months
- Acupuncture last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active acupunctureThe rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments. | Other | active acupuncture + lifestyle management |
| Sham acupunctureIn the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments. | Other | control acupuncture + lifestyle management |
| Lifestyle managementAll women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9). All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week. | Other | active acupuncture + lifestyle management, control acupuncture + lifestyle management |
Primary outcome
Body mass index (BMI)
Time frame: After 4 months of intervention;
PCOS's weight in kilograms divided by the square of her height in meters, reported in kg/m2
42 secondary outcomes
total body fat
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
body fat and lean ratio
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
visceral fat
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
basal metabolic rate
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
antral follicle count
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
sex hormone binding globulin (SHBG)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
anti-mullerian hormone (AMH)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
follicle stimulating hormone (FSH)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
luteinizing hormone (LH)
Time frame: After 4 months of intervention Follow-up 4 months after last treatment.,
Progestin (P)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Estrogen (E2)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Androgen(T)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Androstenedione (A2)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
HOMA-IR
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
HOMA- β
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
glycated hemoglobin ( HbA1c)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
total cholesterol
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
triglycerides
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
high density lipoprotein (HDL)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
low density lipoprotein (LDL)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
lipometabonomic/lipidomics
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
bile acid omics
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
β-endorphin
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
5- hydroxytryptamine (5-HT)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
FerrimanGallwey (FG )value
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
short form-36 (SF36)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
EuroQol health index scale (EQ-5D)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
polycystic ovary syndrome questionnaire (PCOSQ);
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Self-Rating Anxiety Scale (SAS)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Self-Rating Depress Scale (SDS)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Body mass index (BMI)
Time frame: Follow-up 4 months after last treatment.
Fibroblast growth factor 19(FGF-19)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Ghrelin
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 6( IL-6 )
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 8( IL-8 )
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Interleukin 22( IL-22 )
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Tumor Necrosis Factor-Alpha (TNF-α)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Gamma-Amino Butyric Acid(GABA)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
dopamine(DA)
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Glutamate
Time frame: After 4 months of intervention, Follow-up 4 months after last treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
haolin zhang study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active acupuncture and Lifestyle management in people with PCOS and Overweight, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: After 4 months of intervention;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.