The effect of isoflavones in endometriotic pain

JRCT ID: jRCTs051200074

Registered date:27/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: endometriosis
• Date of first enrollment: 27/10/2020
• Target sample size: 110
• Study type: Interventional

Intervention(s)

Active group: Aglycone isoflavone supplements 2 tablets a day (30 mg / day in terms of aglycone isoflavones) for 4 months
Placebo group: Take placebo 2 tablets a day for 4 months

Outcome(s)

• Primary Outcome: Pain improvement effect before and after administration of aglycone isoflavone. Evaluate menstrual pain, nonmenstrual chronic pelvic pain, sexual intercourse pain, urination and defecation pain by VAS at outpatient visit.
• Secondary Outcome: Changes in the size of endometriotic cysts before and after administration of aglycone isoflavones are measured with transvaginal ultrasound. Evaluation of liver function by normal blood sampling. Inquire about the presence or absence of side effects at the visit and continue to confirm safety.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

In patients diagnosed with endometriosis,
(1) Patients younger than 45 years of age who are 20 years old or older
(2) Patients with chronic pelvic pain with a menstrual cycle period of 25 to 38 days and VAS 2.0 or higher

Exclude criteria

(1) Patients who used dietary supplements containing soy isoflavones within 3 months of their visit
(2) Within 3 months from the visit, GnRH analog preparation, endocrine preparation mainly composed of luteinizing hormone or follicular hormone, low-dose pill, medium-dose pill, testosterone derivative and Chinese medicine with indication for endometriosis were used patient
(3) Patients who have undergone surgical treatment for endometriosis with transvaginal alcohol fixation, laparotomy, and laparoscope within 3 months after consultation
(4) Patients who are pregnant or suspected of being pregnant at the time of consultation
(5) Patients who are lactating women at the time of consultation
(6) Patients judged by the attending physician as inappropriate

Related Information

• Primary Sponsor: Taisuke Mori
• Source(s) of Monetary Support: NICHIMO BIOTICS CO.,LTD.