Clinical trial NCT06874738: A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills
Official title: A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Menopausal Syndrome
Keywords: Liuwei Dihuang Pills
The real world
Efficacy
Clinical study
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Lanxi Hospital of Traditional Chinese Medicine
name: First Affiliated Hospital of Harbin Medical University
First posted: 2025-03-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menopausal syndrome refers to a series of physical and psychosomatic symptoms caused by the gradual decline of ovarian function and fluctuating or decreasing levels of sex hormones before and after menopause in women.

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.

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.

Primary outcomes:
measure: Change of Menopausal Symptoms
timeFrame: 4 weeks
measure: Change of Hormone Levels
timeFrame: 4 weeks
Secondary outcomes:
measure: Change of Quality in life
timeFrame: 4 weeks
measure: Change of TCM Syndrome Scores
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese
name: Lianxin Wang
role: PRINCIPAL_INVESTIGATOR
References: