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An observational study on the efficacy and safety of oryzanol injection in the treatment of climacteric syndrome

An observational study on the efficacy and safety of oryzanol injection in the treatment of climacteric syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043321
Enrollment
Unknown
Registered
2021-02-10
Start date
2021-02-08
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Climacteric syndrome

Interventions

Group 1:oryzanol injection for 5 days
Group 2:oryzanol injection for 10 days

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The subjects who can sign the informed consent form voluntarily agree to participate in the study; 2. Women aged 40-60 years; 3. Subjects with menstrual disorder for more than 3 months or menopause for more than 1 year; 4. Subjects with modified K-index score >= 16; 5. Subjects without contraindications of oryzanol injection; 6. Subjects who can receive oryzanol injection for at least 5 days.

Exclusion criteria

Exclusion criteria: 1. Subjects allergic to oryzanol injection or any drug components; 2. Subjects who had been treated with hormone drugs in the past three months; 3. Pregnant and lactating women; 4. Patients with history of endometriectomy, ovariectomy and hysterectomy; 5. Patients with sleep disorders caused by neuropsychiatric diseases and other physical diseases, such as depression, anxiety disorder and sleep apnea syndrome, etc.; 6. Cardio hepatic renal insufficiency includes the following criteria: (1) Serum AST / ALT and bilirubin were more than twice the upper limit of normal; (2) Creatinine was more than twice the normal upper limit; 7. Patients with active autoimmune diseases; 8. Suffering from any disease that the researcher believes makes the patient unfit for the study.

Design outcomes

Primary

MeasureTime frame
Kupperman Score Scale;MENQOL score, PSQI sleep score;

Countries

China

Contacts

Public ContactChen Rong

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

chenrongpumch@163.com+86 13811030947

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026