Overview

This trial is active, not recruiting.

Condition polycystic ovarian syndrome
Treatments acupuncture, diane-35
Phase phase 2
Sponsor Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Start date January 2016
End date August 2018
Trial size 60 participants
Trial identifier NCT02729545, JJ2015-42

Summary

This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Dong's extra-point acupuncture therapy, while the other half will receive Diane-35 as the control group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Dong's extra-point acupuncture treatment,2 times a week for three month
acupuncture
the points are:fuke point, huanchao point,SP6,SP9,EX-CA1 bilaterally,RN4
(Active Comparator)
one tablet a day, take continuously for 21 days, stop for 7 days, and take continuously for another 21 days, totally take 3 menstrual cycle.
diane-35 hormonal tablet
cyproterone acetate 2mg and ethinylestradiol 0.035mg

Primary Outcomes

Measure
the change number of the ratio of luteinizing hormone and follicle-stimulating Hormone(LH/FSH) compared with baseline.
time frame: 3 months

Secondary Outcomes

Measure
the change number of size of ovary compared with baseline.
time frame: 3 months
the change number of luteinizing hormone(LH) compared with baseline
time frame: 3 months
the change number of follicle-stimulating Hormone(FSH) compared with baseline
time frame: 3 months
the percentage of improved ovary (less than 10 follicles) compared with baseline
time frame: 3 months

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: 1. Subject has polycystic ovarian syndrome. 2. Subject doesn't take any hormone medicines or reproductive endocrine drugs for 3 months. 3. Subject has no serious systematic diseases. Exclusion Criteria: 1. Unwillingness to accept either of the two interventions 2. Contra-indications to acupuncture: pacemaker use or bleeding disorder 3. Blood pressure is higher than 160/100mmHg, or have serious diabetes or liver and kidney function is deficiency.

Additional Information

Official title The Efficacy and Safety Study of Dong's Extra-point Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
Principal investigator Yu Cao, master
Description Both Dong's extra-point acupuncture therapy and Diane-35 could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the acupuncture treatment, and do the noninferiority comparison with Diane-35 to definite the efficacy and advantage of acupuncture.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Beijing Hospital of Integrated Traditional Chinese and Western Medicine.