Polycystic Ovarian SyndromeNCT02785965
Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
A study testing electroacupuncture and lifestyle modification in people with Polycystic Ovarian Syndrome and Obesity, Abdominal, run by Dongfang Hospital Beijing University of Chinese Medicine at 2 sites in China.
Trial summary
The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Obesity, Abdominal
- What is being tested?
- electroacupuncture and lifestyle modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2016to Sep 2019
- 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
- Clinical diagnosis of Polycystic Ovarian Syndrome.
- Clinical diagnosis of abdominal obesity.
- Agree to participate in clinical trials.
Who cannot join
- Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
- Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
- Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
- Pregnant or breast feeding.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Dongfang Hospital Affiliated to Beijing University of Chinese
Beijing, Beijing Municipality, 100078
About this study
The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.
Read the detailed description
Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.
Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Abdominal
- Being tested
- electroacupuncture, lifestyle modification
- Keywords
- electroacupuncture, lifestyle modification, diet, exercise, Dai Meridian
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
Disposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min.
lifestyle modificationBehavioural
The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture & lifestyle modification | Experimental | Electro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks. Receives: Device: electroacupuncture; Behavioral: lifestyle modification |
| lifestyle modification | Active comparator | diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks Receives: Behavioral: lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recovered ovulation
the proportion of patients who have ovulation after treatment
Measured: 12 weeks
Secondary outcomes (16)
evidence of clinically definite hyperandrogenism confirmed by mF-G score
Measured: 12 weeks
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
Measured: 12 weeks
frequency of menstruation
Measured: 12 weeks
quantity of menstruation
pictorial blood loss assessment chart
Measured: 12 weeks
Serum total testosterone (T)
Measured: 12 weeks
FSH
follicle stimulating hormone (FSH)
Measured: 12 weeks
LH
luteinizing hormone (LH)
Measured: 12 weeks
ovarian volume measured by ultrasound
Measured: 12 weeks
follicle number pre ovary measured by ultrasound
Measured: 12 weeks
ovarian stromal blood flow measured by ultrasound
Measured: 12 weeks
body weight in kilograms
Measured: 4, 8 and 12 weeks
waist circumference in centimeter
Measured: 4, 8 and 12 weeks
BMI in kg/m^2
Measured: 4, 8 and 12 weeks
waist-to-height ratio
waist-to-height ratio=waist circumference in centimeter/height in centimeter
Measured: 4, 8 and 12 weeks
Fasting serum PAI-1 level
Measured: 12 weeks
International physical activity scale (IPAQ) short version
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Hui Hu, Dongfang Hospital Beijing University of Chinese Medicine
- Investigators
- Hui HU, Doctor, Principal investigator, Dongfang Hospital Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785965
- Sponsor's protocol ID
- Z161100000516057
- Status last verified
- Sep 2017
- First submitted
- 23 May 2016
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Abazar E, Taghian F, Mardanian F, Forozandeh D. Effects of aerobic exercise on plasma lipoproteins in overweight and obese women with polycystic ovary syndrome. Adv Biomed Res. 2015 Mar 25;4:68. doi: 10.4103/2277-9175.153892. eCollection 2015.
PubMed 25878993Case problem: dietary recommendations to combat obesity, insulin resistance, and other concerns related to polycystic ovary syndrome. J Am Diet Assoc. 2000 Aug;100(8):955-7; discussion 957-60. doi: 10.1016/S0002-8223(00)00275-3. No abstract available.
PubMed 10955058
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT02785965
- Acronym / sponsor ID
- Z161100000516057
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Abdominal
- Keywords
- electroacupuncture, lifestyle modification, diet, exercise, Dai Meridian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, Beijing Municipal Science & Technology Commission
- Study start
- Jul 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 30 May 2016 (estimated)
- 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.
The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.
Detailed description
Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.
Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture & lifestyle modification | Experimental | Device: electroacupuncture, Behavioral: lifestyle modificationElectro-acupuncture is given three times a week with diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks. |
| lifestyle modification | Active comparator | Behavioral: lifestyle modificationdiet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Polycystic Ovarian Syndrome.
- Clinical diagnosis of abdominal obesity.
- Agree to participate in clinical trials.
Key exclusion criteria (4 listed)
- Endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, Cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia.
- Patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness).
- Patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results.
- Pregnant or breast feeding.
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 |
|---|---|---|
| electroacupunctureDisposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min. | Device | acupuncture & lifestyle modification |
| lifestyle modificationThe diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises. | Behavioural | acupuncture & lifestyle modification, lifestyle modification |
Primary outcome
rate of recovered ovulation
Time frame: 12 weeks
the proportion of patients who have ovulation after treatment
16 secondary outcomes
evidence of clinically definite hyperandrogenism confirmed by mF-G score
Time frame: 12 weeks
evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System
Time frame: 12 weeks
frequency of menstruation
Time frame: 12 weeks
quantity of menstruation
Time frame: 12 weeks
Serum total testosterone (T)
Time frame: 12 weeks
FSH
Time frame: 12 weeks
LH
Time frame: 12 weeks
ovarian volume measured by ultrasound
Time frame: 12 weeks
follicle number pre ovary measured by ultrasound
Time frame: 12 weeks
ovarian stromal blood flow measured by ultrasound
Time frame: 12 weeks
body weight in kilograms
Time frame: 4, 8 and 12 weeks
waist circumference in centimeter
Time frame: 4, 8 and 12 weeks
BMI in kg/m^2
Time frame: 4, 8 and 12 weeks
waist-to-height ratio
Time frame: 4, 8 and 12 weeks
Fasting serum PAI-1 level
Time frame: 12 weeks
International physical activity scale (IPAQ) short version
Time frame: 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 25878993Abazar E, Taghian F, Mardanian F, Forozandeh D. Effects of aerobic exercise on plasma lipoproteins in overweight and obese women with polycystic ovary syndrome. Adv Biomed Res. 2015 Mar 25;4:68. doi: 10.4103/2277-9175.153892. eCollection 2015.
- Background: PubMed 10955058Case problem: dietary recommendations to combat obesity, insulin resistance, and other concerns related to polycystic ovary syndrome. J Am Diet Assoc. 2000 Aug;100(8):955-7; discussion 957-60. doi: 10.1016/S0002-8223(00)00275-3. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Hui HU, Doctor principal investigator
Dongfang Hospital Beijing University of Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and lifestyle modification in people with Polycystic Ovarian Syndrome and Obesity, Abdominal, run by Dongfang Hospital Beijing University of Chinese Medicine at 2 sites 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
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?
rate of recovered ovulation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785965, which also lists 2 linked publications.
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 12 Sep 2017.