Effect of gyejibongneyong-hwan for treatment of dysmenorrhea of uterine fibroids caused by blood stasis: A double blind, randomized placebo controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001967

Enrollment

Registered

2016-07-12

Start date

2016-07-11

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : GH is a Korean medicine formula for the treatment of dysmenorrhea caused by blood stasis. The participants will take the investigational drug, either GH or placebo, three times per day for two

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Females between 18 and 45 years of age and diagnosed with Blood stasis syndrome. 2.Females diagnosed blood stasis through screening test at gynecology 3.Confirmation of uterine myomas by ultrasonography (over 2 cm). 4.Provide written informed consent to participate in the study. 5.Agree to comply with the study regulations.

Exclusion criteria

Exclusion criteria: 1. Patients with heart disease, liver disease, kidney disease or any psychiatric condition. 2. Patients who are unable to communicate or are critically ill. 3. Pregnant women. 5. Patients who take regular medication, including serotonin, anti-depressants, or other anti-psychiatric drugs. 4. Patients with any condition that could influence the study assessment.

Design outcomes

Primary

Measure	Time frame
Numerical rating scale	—

Secondary

Measure	Time frame
Screening question using blood stasis table;SFM-PQ;Dosage of analgesic ; Cox menstrual symptom scale;Size of myoma uteri	—

Countries

Korea, Republic of

Contacts

Public ContactJU AH LEE

Woosuk University

lovedmsl@hanmail.net

Outcome results