Clinical trial NCT06074809: RCT on the Treatment of Menopausal Syndrome With Chinese Medicine
Official title: Clinical Trial on the Treatment of Menopausal Syndrome With Chinese Medicine Gui-zhi-fu-ling-wan With Variation and the Mechanism of Anti-inflammation and Body Surface Temperature Distribution
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Menopause
Keywords: Traditional Chinese medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 78
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Greene Climacteric Scale (Chinese version)
timeFrame: Week 8
Secondary outcomes:
measure: Short-Form Health Survey, SF-12v2 (Chinese version)
timeFrame: Week 8
measure: Short-Form Health Survey, SF-12v2 (Chinese version)
timeFrame: Week 12
measure: Temperature change of face, limbs and abdomen
timeFrame: Week 8
measure: Temperature change of face, limbs and abdomen
timeFrame: Week 12
measure: Level change of sex hormones
timeFrame: Week 8
measure: Level change of sex hormones
timeFrame: Week 12
measure: Level change of inflammatory markers
timeFrame: Week 8
measure: Level change of inflammatory markers
timeFrame: Week 12
measure: Greene Climacteric Scale (Chinese version)
timeFrame: Week 12
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: School of Chinese Medicine
Study officials:
affiliation: School of Chinese Medicine
name: Hongwei Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: