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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072875
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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:Kunbao Pill
Group 2:Kuntai Jiaonang

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

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 Yin deficiency of the liver and kidney pattern; 3. The course of disease shall not exceed 24 months; 4. The total score of domestic improved Kupperman = 15; 5. 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;Positive and Negative Affect Schedule;Four sex hormones (estradiol, follicle stimulating hormone, luteinizing hormone, progesterone);anti-mullerian hormone;Inhibin B;

Countries

China

Contacts

Public ContactLing Tang

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

tangling73@126.com+86 186 1115 2117

Outcome results

None listed

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