A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills

NCT ID: NCT06874738

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-08
• Study Completion Date: 2026-12-30

Brief Summary

To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.

Detailed Description

In this study, the patients were divided into exposed and non-exposed groups based on whether or not they were taking Liuwei Dihuang Pills.

The patients in the non-exposed group were treated routinely, and the patients in the exposed group were treated routinely + Liuwei Dihuang Pills. The patients in the exposed group were required to take the medication according to the dosage instructions for at least 4 consecutive weeks. Combined use of drugs is allowed without interfering with the treatment plan, and the use of drugs and combined use of drugs should be recorded truthfully, including the dose, duration, frequency, and so on. The type of drugs used in combination and the corresponding daily dose, daily frequency and duration of treatment. During the course of treatment, patients in both groups were required to receive follow-up assessment once every 4 weeks. Termination of the study included death, loss of patients, or achievement of study endpoints.

Conditions

Menopausal Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liuwei Dihuang Pills

The intervention in this cohort consisted of the Six-flavoured Dihuang Pill and the rest of the conventional treatment.

Liuwei Dihuang pills

Intervention Type: DRUG

Conventional treatment （Hormones, selective 5-hydroxytryptamine reuptake inhibitors, etc.）+ Liu Wei Di Huang Pills

Interventions

Liuwei Dihuang pills

Conventional treatment （Hormones, selective 5-hydroxytryptamine reuptake inhibitors, etc.）+ Liu Wei Di Huang Pills

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 45-55 years old

2. Patients with menopausal syndrome using Liuwei Dihuang Pills

3. Kidney Yin Deficiency Syndrome

Exclusion Criteria

1. Individuals allergic to any components of the drug or excipients;

2. Individuals with other endocrine diseases;

3. Individuals with organic lesions of the reproductive system;

4. Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;

5. Individuals with endometrial hyperplasia or unexplained vaginal bleeding;

6. Individuals with malignant tumors, hematologic, or immune system diseases;

7. Individuals with severe cardiovascular, cerebrovascular, liver, or kidney diseases (e.g., serum transaminase levels more than 1.5 times the upper limit of normal, serum creatinine above the upper limit of normal);

8. Individuals with psychiatric disorders or dependence on alcohol or drugs;

9. Individuals with mental illness or communication barriers;

10. Individuals with other conditions that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate the study process are not suitable for participation in this clinical research.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Lianxin Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lianxin Wang

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese

Central Contacts

Lianxin Wang

Role: CONTACT

wlxing2022@163.com

86-13521781839

Shichu Zhao

Role: CONTACT

18513049612@163.com

86-18513049612

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Liuwei Dihuang Pills

Identifier Type: -

Identifier Source: org_study_id