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

NCT06874738 | Not Yet Recruiting DMC

• 1 other identifier: Liuwei Dihuang Pills
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopausal Syndrome

Keywords

Liuwei Dihuang Pills; The real world; Efficacy; Clinical study

Outcome Measures

Primary Outcomes (2)

• Change of Menopausal Symptoms

  The Kupperman Rating Scale is a global tool for assessing menopausal symptoms. It has 13 items covering common perimenopausal symptoms like hot flashes, sweating, paresthesia, insomnia, irritability, depression, dizziness, fatigue, arthralgia, headache, palpitations, formication, urinary infections, and sexual status. Each item is weighted and summed for a total score of 0-63. A lower score means more severe perimenopausal symptoms.The modified Kupperman Rating Scale will be used to assess menopausal symptoms. Participants will complete the questionnaire before, after treatment, and during follow-up. Researchers will calculate the total score.

  4 weeks

• Change of Hormone Levels

  Sex hormone levels are key for evaluating the endocrine status of menopausal women. In patients with menopausal syndrome, sex hormone levels show elevated Follicle-Stimulating Hormone and Luteinizing Hormone, and reduced Estradiol. High Follicle-Stimulating Hormone points to ovarian dysfunction. Changes in the Luteinizing Hormone/Follicle-Stimulating Hormone ratio may be linked to polycystic ovary syndrome, and decreased Estradiol is associated with ovarian failure.

  4 weeks

Secondary Outcomes (2)

• Change of Quality in life

  4 weeks

• Change of TCM Syndrome Scores

  4 weeks

Study Arms (1)

Liuwei Dihuang Pills

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

Drug: Liuwei Dihuang pills

Interventions

Liuwei Dihuang pills DRUG

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

Liuwei Dihuang Pills

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age: 45-55 years old
• Patients with menopausal syndrome using Liuwei Dihuang Pills
• Kidney Yin Deficiency Syndrome

You may not qualify if:

• Individuals allergic to any components of the drug or excipients;
• Individuals with other endocrine diseases;
• Individuals with organic lesions of the reproductive system;
• Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;
• Individuals with endometrial hyperplasia or unexplained vaginal bleeding;
• Individuals with malignant tumors, hematologic, or immune system diseases;
• 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);
• Individuals with psychiatric disorders or dependence on alcohol or drugs;
• Individuals with mental illness or communication barriers;
• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Lanxi Hospital of Traditional Chinese Medicine: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood,Serum

Study Officials

• Lianxin Wang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianxin Wang

CONTACT

86-13521781839; wlxing2022@163.com

Shichu Zhao

CONTACT

86-18513049612; 18513049612@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 13, 2025
• Study Start: March 8, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share