Polycystic Ovary SyndromeNCT02326714
Auricular Acupressure (AA) For Overweight/Obese Adolescent and Young Polycystic Ovary Syndrome ( PCOS)
A study testing Auricular acupressure in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 1 site in China.
Trial summary
The purpose of this trial is to investigate the effect and safety of auricular acupressure on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms: Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for three months. Read more about this study
- Who is it for?
- Ages 12 to 25 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Auricular acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 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 12 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women aged between 12 and 25 years.
- Diagnosis of PCOS according to the modified Rotterdam criteria.
- 2 years after menarche.
- Body mass index (BMI) equal to or greater than 23 kg/m*m.
Who cannot join
- Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- Patients with known severe organ dysfunction or mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
Lihui Hou, Bachelor, 86-451-82111401, houlihui2007@sina.com
About this study
Official title: Effect of Auricular Acupressure on Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome.
The purpose of this trial is to investigate the effect and safety of auricular acupressure on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms: Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic profile will be determined.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Auricular acupressure, Placebo auricular acupressure
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureOther
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
Placebo auricular acupressureOther
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupressure | Experimental | The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen. Receives: Other: Auricular acupressure |
| Placebo auricular acupressure | Placebo comparator | The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow. Receives: Other: Placebo auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI): BMI change at 3 months.
Measured: 3 month
Secondary outcomes (10)
Oral glucose tolerance test (OGTT)
Measured: 3 month
Testosterone (T)
Measured: 3 month
Sex hormone-binding globulin (SHBG)
Measured: 3 month
Dehydroepiandrosterone sulfate (DHEAS).
Measured: 3 month
Follicle stimulating hormone (FSH)
Measured: 3 month
Luteinizing hormone (LH)
Measured: 3 month
Cholesterol
Measured: 3 month
Triglycerides (TG)
Measured: 3 month
Waist/hip ratio
Measured: 3 month
Ferriman-Gallwey score
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Heilongjiang University of Chinese Medicine
- Investigators
- Lihui Hou, Bachelor, Study chair, First Affiliated Hospital of Heilongjiang University Of Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326714
- Sponsor's protocol ID
- AA for PCOS
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2014
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Auricular Acupressure on Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT02326714
- Acronym / sponsor ID
- AA for PCOS
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 29 Dec 2014 (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 trial is to investigate the effect and safety of auricular acupressure on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms: Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic profile will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupressure | Experimental | Other: Auricular acupressureThe magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen. |
| Placebo auricular acupressure | Placebo comparator | Other: Placebo auricular acupressureThe magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Women aged between 12 and 25 years.
- Diagnosis of PCOS according to the modified Rotterdam criteria.
- 2 years after menarche.
- Body mass index (BMI) equal to or greater than 23 kg/m*m.
Key exclusion criteria (3 listed)
- Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
- Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
- Patients with known severe organ dysfunction or mental illness.
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 |
|---|---|---|
| Auricular acupressureThe magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear. | Other | Auricular acupressure |
| Placebo auricular acupressureThe magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear. | Other | Placebo auricular acupressure |
Primary outcome
Body mass index (BMI): BMI change at 3 months.
Time frame: 3 month
10 secondary outcomes
Oral glucose tolerance test (OGTT)
Time frame: 3 month
Testosterone (T)
Time frame: 3 month
Sex hormone-binding globulin (SHBG)
Time frame: 3 month
Dehydroepiandrosterone sulfate (DHEAS).
Time frame: 3 month
Follicle stimulating hormone (FSH)
Time frame: 3 month
Luteinizing hormone (LH)
Time frame: 3 month
Cholesterol
Time frame: 3 month
Triglycerides (TG)
Time frame: 3 month
Waist/hip ratio
Time frame: 3 month
Ferriman-Gallwey score
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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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.
Lihui Hou, Bachelor study chair
First Affiliated Hospital of Heilongjiang University Of Chinese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine 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 3 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 20 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, Doctor (+86-451-82111401, liyantcm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI): BMI change at 3 months. (time frame: 3 month). 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 20 Dec 2017.