Evaluation of the Effect of Equol on Hand Osteoarthritis in Perimenopausal Women

JRCT ID: jRCTs051230208

Registered date:21/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hand osteoarthritis
• Date of first enrollment: 28/03/2024
• Target sample size: 220
• Study type: Interventional
• Intervention(s): Enrolled patients will be randomly assigned to receive either 10 mg/day of Equel or 2 tablets/day of a placebo using a minimization method with the facility as the allocation adjustment factor. After 12 weeks of oral intake in a double-blind fashion, study subjects who meet eligibility criteria for the continuation part will receive an additional 12 weeks of open-label oral intake of Equel 10 mg/day.

Outcome(s)

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

Secondary Outcome

Change in the following variables after 4, 8, 12 and 24 weeks of oral intake of equol or a placebo versus the baseline:
(1)VAS on movement
(2)VAS at rest
(3)Number of finger joints with pain
(4)DASH score

Key inclusion & exclusion criteria

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

Include criteria

For provisional registration:
1)Women aged 45-60 years.
2)Pain in hand joints over more than 3 months.
3)At least 3 months of follow-up.
4)Written informed consent prior to study.
For full registration:
1)Hand osteoarthritis of Grade 0 or higher according to Kellgren and Lawrence classification.
2)Equol non-producer in the screening test.

3)Pain in hand joints over more than 3 months.
4)At least 3 months of follow-up.

Exclude criteria

For provisional registration:
1)VAS on movement less than 30 mm at the time of provisional registration.
2)Surgical menopause (bilateral ovariectomy).
3)Rheumatoid arthritis or other collagen diseases.
4)Thyroid dysfunction.
5)History of hand trauma causing current pain or deformity of the hands.
6)Use of antimicrobial agents at the time of provisional registration (except as periodic oral medication).
7)Acute diarrhea at the time of provisional registration.
8)Use of intra-articular steroid injection for hand pain.
9)History of surgery for osteoarthritis of the hands.
10)Planned surgery for hand pain within 3 months of full registration.
11)Depressive or mood disorders.
12)Allergy to soy.
13)Use of prescriptions for menopausal symptoms, including hormonal agents, herbal medicine and SERMs.
14)History of uterine, ovarian, or breast cancer.
15)Use of the test supplements (trade name: Equel) within a year of provisional registration.
16)Participants of the previous study (jRCT s1190066) of this study.
17)Taking foods containing equol at the time of obtaining consent.
18)Use of analgesics regularly for at least 2 weeks at the time of obtaining consent (except for use as topically-acting external medicine).
19)Use of anti-inflammatory or immunosuppressive drugs such as steroids.
20)Dialysis.
21)History of gastrectomy (except for endoscopic treatment and partial gastrectomy).
22)Current use of oral contraceptives.
23)Pregnancy or lactating.
24)Patients who are otherwise judged inappropriate by the researcher.
For full registration:
1)Undeniable rheumatoid arthritis or thyroid dysfunction on screening blood tests.
2)History of hand traumas causing current pain or deformity of the hands.
3)Use of intra-articular steroid injection for hand pain.
4)Planned surgery for hand pain within 3 months of full registration.
5)Depressive or mood disorders.
6)Use of prescriptions for menopausal symptoms, including hormonal agents, herbal medicine and SERMs.
7)Use of the test supplements (trade name: Equel) within a year of provisional registration.
8)Use of analgesics regularly for at least 2 weeks at the time of full registration (except as topically-acting external medicine).
9)Use of anti-inflammatory or immunosuppressive drugs such as steroids.
10)Dialysis.
11)History of gastrectomy (except for endoscopic treatment and partial gastrectomy).
12)Current use of oral contraceptives.
13)Pregnancy or lactating.
14)Patients who are otherwise judged to be inappropriate by the researcher.

Related Information

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