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Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

NCT04509817 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-29

No results posted yet for this study

Summary

This study is an international multicenter, pilot randomized, assessor-blind, controlled trial, which is aimed to preliminarily investigate the efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome (PCOS).

Conditions

  • Polycystic Ovary Syndrome
  • Oligomenorrhea

Interventions

DEVICE

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.

BEHAVIORAL

Usual care

Usual care intervention The subjects will receive the health advice

Sponsors & Collaborators

  • Korea Institute of Oriental Medicine

    collaborator OTHER_GOV

  • Dongzhimen Hospital, Beijing

    collaborator OTHER

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Chunlan Jin, MD · Institute of acupuncture and moxibustion, CACMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • China
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509817 on ClinicalTrials.gov