Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
NCT ID: NCT04509817
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-11-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture+Usual care
Subjects in experimental group will receive a standardized acupuncture treatment, 10 times per 4 weeks for 16 weeks with a total of 40 sessions in addition to usual care.
Acupuncture+Usual care
Acupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation.
Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Usual care
Subjects in control group will receive usual care only.
Usual care
Usual care intervention The subjects will receive the health advice
Interventions
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Acupuncture+Usual care
Acupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation.
Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Usual care
Usual care intervention The subjects will receive the health advice
Eligibility Criteria
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Inclusion Criteria
* 20-40 years of age
* Voluntary agreement to participate in this trial
Exclusion Criteria
* Intake of oral contraceptive or ovulation inducing agent within the past 3 months
* Severe oligomenorrhea with menstrual period over 3 months
* Menstruation during more than 8 days
* Premature ovarian failure
* Resistant thyroid disease, Cushing's disease, congenital adrenal hyperplasia, or hyperprolactinemia
* Ovarian tumor or adrenal tumor that cause hyperandrogenemia
* Hemorrhagic disease
* Severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorders, or intake of psychoactive drug
* Acupuncture treatment within the past one month
* Participation in other clinical trial within the past 3 months
* Other conditions judged to be inappropriate for the clinical study by the investigators
20 Years
40 Years
FEMALE
No
Sponsors
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Korea Institute of Oriental Medicine
OTHER_GOV
Dongzhimen Hospital, Beijing
OTHER
Kyung Hee University Hospital at Gangdong
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Chunlan Jin
Associated professor
Principal Investigators
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Chunlan Jin, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of acupuncture and moxibustion, CACMS
Locations
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Dongzhimen Hospital
Beijing, Beijing Municipality, China
Institute of acupuncture and moxibustion
Beijing, Beijing Municipality, China
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Park KS, Gang W, Kim PW, Yang C, Jun P, Jung SY, Kwon O, Lee JM, Lee HJ, Lee SJ, Jing X, Zhang N, Hu J, Zhao J, Pang R, Jin C, Lee JH. Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial. Medicine (Baltimore). 2022 Feb 18;101(7):e28674. doi: 10.1097/MD.0000000000028674.
Other Identifiers
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KHNMCOH 2017-12-003
Identifier Type: OTHER
Identifier Source: secondary_id
GH201802
Identifier Type: -
Identifier Source: org_study_id