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Clinical Study on the Treatment of Climacteric (Menopausal) Syndrome with Jiawei Xiaoyao Pill

Clinical Study on the Treatment of Climacteric (Menopausal) Syndrome with Jiawei Xiaoyao Pill

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064974
Enrollment
Unknown
Registered
2022-10-25
Start date
2022-10-28
Completion date
Unknown
Last updated
2023-05-15

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:modified xiaoyao pill
Group 2:Xiangshao Granules

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Conforming to the diagnostic criteria of western medicine for menopausal (menopausal) syndrome; 2. It conforms to the syndrome differentiation standard of liver depression and fire; 3. The course of disease shall not exceed 24 months; 4. The total score of domestic improved Kupperman >= 15; 5. The score of Beck Self Rating Depression Scale (BDI) was 5-15; 6. The score of Beck Self Rating Anxiety Scale (BAI) is 15-35; 7. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. History of endometrial hyperplasia or vaginal bleeding with unknown cause; 2. Known or suspected pregnancy; 3. Those suffering from thrombotic disease in the last six months; 4. Known patients with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system, diabetes, thyroid disease, malignant tumor, and psychosis; 5. Severe liver and kidney dysfunction; 6. Those who have participated in other clinical researches in the past month, or who have used relevant Chinese and western medicines to treat the disease in the past month, so that the drug effect cannot be judged; 7. Those allergic to the test drug; 8. Suspected or confirmed to have a history of alcohol addiction and drug abuse, or other diseases or conditions that, according to the judgment of the researcher, reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, unstable living environment and other conditions that are likely to cause loss of follow-up; 9. The investigator thinks it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
TCM syndrome integral table;Improved Kupperman Rating Scale in China;

Secondary

MeasureTime frame
MENQOL scale;Beck Depression Inventory;Beck Anxiety Inventory;Four sex hormones (estradiol, follicle stimulating hormone, luteinizing hormone, progesterone);anti-mullerian hormone;Inhibin B;Central neurotransmitters (5-HT, DA);

Countries

China

Contacts

Public ContactLing Tang

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

tangling73@126.com+86 18611152117

Outcome results

None listed

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