RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

NCT ID: NCT06074809

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-01-31

Brief Summary

This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12.

Detailed Description

Menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. These symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction.

Some previous studies have investigated the possibilities of using traditional Chinese medicine (TCM) for the treatment of menopausal syndrome. However, due to the limitations of previous clinical research, more evidence is required to support the efficacy of TCM treatment. Therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using TCM to treat menopausal syndrome.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Traditional Chinese medicine treatment group

Chinese medicine will be administered to patients in this group.

Group Type: EXPERIMENTAL

Modified Guizhi Fuling granules

Intervention Type: DRUG

Modified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.

Placebo group

Placebo will be administered to patients in this group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.

Interventions

Modified Guizhi Fuling granules

Modified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.

Intervention Type: DRUG

Placebo

Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.

Intervention Type: OTHER

Other Intervention Names

Chinese medicine

Eligibility Criteria

Inclusion Criteria

• Female subjects with age between 40 and 60 years old;
• For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
• The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
• Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
• Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner
• Agreed to receive Chinese medication or placebo for 2 months upon randomization.

Exclusion Criteria

• The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
• Have received estrogen treatment in the past 2 months;
• Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
• Known serious emotional, mental or psychological disorders that may affect the study;
• During pregnancy, pre-pregnancy period, or lactation period;
• Known history of allergy to any traditional Chinese medicine;
• Have received anticoagulant or antiplatelet drugs in the past month;
• Known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions;
• Chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of Yin blood or absence of static blood pattern.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Zhang Hongwei

School of Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongwei Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine

Locations

School of Chinese Medicine

Shatin, , Hong Kong

Countries

Hong Kong

Central Contacts

Hongwei Zhang, PhD

Role: CONTACT

zhanghw@cuhk.edu.hk

39439845

Cho Wing Lo

Role: CONTACT

louislo@cuhk.edu.hk

35053476

Other Identifiers

Menopause study

Identifier Type: -

Identifier Source: org_study_id