A Phase 2 interventional study of Modified Guizhi Fuling granules and Placebo in Menopause, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
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.
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.
Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Chinese medicine will be administered to patients in this group.
Drug: Modified Guizhi Fuling granules
Placebo will be administered to patients in this group.
Other: Placebo
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.
Also known as: Chinese medicine
Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.
Greene Climacteric Scale (Chinese version)
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.
Time frame: Week 8
Short-Form Health Survey, SF-12v2 (Chinese version)
The SF-12v2 is the brief version of SF-36, consisting of 12 questions related to our physical, mental health and functionality. It is used as a supportive tool to comprehensively assess the health status of the patient. Scores range from 0 to 100, with higher scores representing better self-reported health.
Time frame: Week 8
Short-Form Health Survey, SF-12v2 (Chinese version)
The SF-12v2 is the brief version of SF-36, consisting of 12 questions related to our physical, mental health and functionality. It is used as a supportive tool to comprehensively assess the health status of the patient. Scores range from 0 to 100, with higher scores representing better self-reported health.
Time frame: Week 12
Temperature change of face, limbs and abdomen
The peripheral temperature of the face, limbs and abdomen of the patients will be measured by a thermographic camera.
Time frame: Week 8
Temperature change of face, limbs and abdomen
The peripheral temperature of the face, limbs and abdomen of the patients will be measured by a thermographic camera.
Time frame: Week 12
Level change of sex hormones
Level change of Estradiol (E2) and Follicle-stimulating hormone (FSH) will be measured between baseline and week 8.
Time frame: Week 8
Level change of sex hormones
Level change of Estradiol (E2) and Follicle-stimulating hormone (FSH) will be measured between baseline and week 12.
Time frame: Week 12
Level change of inflammatory markers
Level change of the serum inflammatory factors: high-sensitivity C-reactive protein (hsCRP), Interleukin 6 (IL-6) , Interleukin 8 (IL-8) and Tumor necrosis factor-α (TNF-α) will be measured from baseline to week 8.
Time frame: Week 8
Level change of inflammatory markers
Level change of the serum inflammatory factors: high-sensitivity C-reactive protein (hsCRP), Interleukin 6 (IL-6) , Interleukin 8 (IL-8) and Tumor necrosis factor-α (TNF-α) will be measured from baseline to week 12.
Time frame: Week 12
Greene Climacteric Scale (Chinese version)
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.
Time frame: Week 12
Start is estimated for Nov 2023; primary completion for Oct 2025, 23 months later.
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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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