The Effect of Equol for Hand Osteoarthritis in Perimenopausal Women

JRCT ID: jRCTs051190066

Registered date:23/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hand Osteoarthritis
• Date of first enrollment: 07/11/2019
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Oral intake of equal 10mg bid (two 2.5mg tablets each) after breakfast and after dinner daily for 12 weeks

Outcome(s)

• Primary Outcome: Change in VAS on movement after 12 weeks of oral intake of equol versus baseline

Secondary Outcome

1. Changes in the following variables after 4, 8 and 12 weeks of equol intake versus baseline
(1) VAS on movement
(2) VAS at rest
(3) Number of finger joints with pain
(4) EQ-5D-5L
(5) DASH score
(6) SMI
(7) VAS for menopausal symptoms
2. Correlation between change in VAS on movement after 12 weeks of equol intake and the following variables at baseline
(1) Maximum KL grade for each patient
(2) Total KL score of 30 finger joints of the hands for each patient
(3) Patient satisfaction
3. Patient satisfaction after 12 weeks of equol intake

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: <= 60age old
• Gender: Female

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Shimoe Takashi
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co., LTD