RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

The Chinese University of Hong Kong

Status and phase: Not yet enrolling; Phase 2

Conditions: Menopause

Treatments: Drug: Modified Guizhi Fuling granules; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06074809

Menopause study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Traditional Chinese medicine treatment group

Experimental group

Description:

Chinese medicine will be administered to patients in this group.

Treatment:

Drug: Modified Guizhi Fuling granules

Placebo group

Placebo Comparator group

Description:

Placebo will be administered to patients in this group.

Treatment:

Other: Placebo