NCT02785965

Brief 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 obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

May 23, 2016

Last Update Submit

September 11, 2017

Conditions

Polycystic Ovarian SyndromeObesity, Abdominal

Keywords

electroacupuncturelifestyle modificationdietexerciseDai Meridian

Outcome Measures

Primary Outcomes (1)

  • rate of recovered ovulation

    the proportion of patients who have ovulation after treatment

    12 weeks

Secondary Outcomes (16)

  • evidence of clinically definite hyperandrogenism confirmed by mF-G score

    12 weeks

  • evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System

    12 weeks

  • frequency of menstruation

    12 weeks

  • quantity of menstruation

    12 weeks

  • Serum total testosterone (T)

    12 weeks

  • +11 more secondary outcomes

Study Arms (2)

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.

Device: electroacupunctureBehavioral: lifestyle modification

lifestyle modification

ACTIVE COMPARATOR

diet restriction to 1400 calories a day and moderate aerobic exercise 3h a week for 12 weeks

Behavioral: lifestyle modification

Interventions

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.

acupuncture & lifestyle modification
lifestyle modificationBEHAVIORAL

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.

acupuncture & lifestyle modificationlifestyle modification

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Polycystic Ovarian Syndrome.
  • Clinical diagnosis of abdominal obesity.
  • Agree to participate in clinical trials.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100078, China

Location

Dongfang Hospital Affiliated to Beijing University of Chinese

Beijing, Beijing Municipality, 100078, China

Location

Related Publications (2)

  • 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.

    PMID: 25878993BACKGROUND

  • Case 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.

    PMID: 10955058BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity, AbdominalMotor Activity

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Hui HU, Doctor

    Dongfang Hospital Beijing University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,clinical research

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 30, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2019

Study Completion

September 1, 2019

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

CN(2)