The Effect of Equol for Hand Osteoarthritis in Perimenopausal Wome

Phase 2

• Conditions: Hand Osteoarthritis

• Registration Number: JPRN-jRCTs051190066
• Lead Sponsor: Shimoe Takashi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Study Completion: 2021-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 148

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VAS on movement after 12 weeks of oral intake of equol versus baseline

Secondary Outcome Measures

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