JPRN-jRCTs051190066已完成2 期
A Pilot Study, Effects of Equol on Hand Osteoarthritis in Perimenopausal Women
Shimoe Takashi0 个研究点目标入组 148 人开始时间: 2019年10月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
研究概览
简要总结
This is the first prospective clinical trial of equol supplement as a treatment for pain caused by osteoarthritis of the hands. The primary outcome, VAS on movement, improved with statistically significant differences after 4, 8, 12 weeks of equal intake versus baseline. Equol intake improved the pain caused by the disease. In addition, it was found that the VAS improvement was observed within a relatively short period of 1 to 3 months after the equal intake. DASH score and EQ-5D-5L also showed significant
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 45age old 至 <= 60age old（—）
- 性别
- Female
入选标准
- •1) Women aged 45 - 60 years providing consent
- •2) Pain in hand joints over period more than 3 months
- •3) Hand osteoarthritis of Grade 0 or higher according to Kellgren and Lawrence classification
- •4) Equol non-producer
- •5) Three months of follow-up is available
- •6) Obtained written informed consent prior to study
排除标准
- •1) Surgical menopause
- •2) Rheumatoid arthritis or other collagen diseases
- •3) Thyroid dysfunction
- •4) History of hand traumas causing current pain or deformity of the hands
- •5) Mental problems more than 11 points on HADS
- •6) Allergy to soy
- •7) Use of prescriptions for menopausal symptoms, including hormonal agents, herbal medicine and SERMs
- •8) Use of food products containing equol other than the test supplement (trade name: Equel)
- •9) Chronic use of analgesics
- •10) Current use of oral contraceptives
- •11) Pregnancy or lactating
- •12) Patients who are otherwise judged inappropriate by the researcher
研究者
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