NCT04509817

Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. The subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.

Conditions

• Polycystic Ovary Syndrome
• Oligomenorrhea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2020-08-12
• Last updated: 2020-10-29

Locations

3 sites across 2 countries: China, South Korea