Hand Osteoarthritis
Conditions
Interventions
Oral intake of equal 10mg bid (two 2.5mg tablets each) after breakfast and after dinner daily for 12 weeks
Sponsors
Shimoe Takashi
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS on movement after 12 weeks of oral intake of equol versus baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTakashi Shimoe
Wakayama Medical University Hospital
Outcome results
None listed