Endometriosis-Associated Pain
Conditions
Interventions
Treatment group:Huoxue Xiaoyi Formula Granules for Oral Use
Placebo group:Huoxue Xiaoyi Formula Granules Simulator for Oral Use
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for endometriosis in Western medicine and the criteria for qi stagnation and blood stasis syndrome in traditional Chinese medicine; (2) Be between 18 and 50 years of age; (3) Have pelvic pain lasting =3 months, with the most severe pain scoring =40mm on the Visual Analog Scale (VAS); (4) Have a regular menstrual cycle (menstrual cycle of 28±3 days); (5) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with abnormal uterine bleeding or endometrial lesions, acute pelvic inflammatory disease, uterine cavity adhesions, pelvic tuberculosis, or those who have undergone hysterectomy; (2) Patients who have received hormone therapy in the past 3 months, including oral contraceptives, GnRH-a, progesterone, etc.; or patients who have undergone traditional Chinese medicine treatment or non-drug therapy (acupuncture, moxibustion, etc.) for endometriosis in the past 1 month; (3) Patients with hemoglobin concentration 6 cm); or patients who require analgesics due to other underlying diseases; (5) Patients with serum creatinine exceeding the upper limit of normal, or abnormal liver function (ALT or AST >1.5 times the upper limit of normal) deemed clinically significant by the investigator; (6) Pregnant women, women planning pregnancy within the next 6 months, or breastfeeding women; (7) Patients with severe primary diseases such as severe cardiovascular, cerebrovascular, hepatic, renal, hematologic disorders, diabetes, thyroid diseases (thyroid nodules BI-RADS classification >3), or breast diseases (breast nodules BI-RADS classification >3), or patients with mental illness; (8) Patients with allergic constitutions or those allergic to any components of the study drug; (9) Patients who have participated in other clinical studies within the past 1 month; (10) Patients with suspected or confirmed alcohol dependence, drug abuse history, or other conditions that may reduce the likelihood of enrollment or complicate participation, such as frequent changes in work environment or unstable living conditions, which may lead to loss to follow-up; (11) Patients who refuse randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Visual Analogue Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Duration;Ibuprofen tablets usage;Multidimensional Pain Assessment;Mood State;Quality of life;Central Sensitization Scale;Patient Satisfaction;Traditional Chinese Medicine (TCM) Syndrome Scoring Scale;Serum Cancer Antigen 125 Level;Lesion size;Gynecological examination; | — |
Countries
China
Contacts
Public ContactZhao Ruihua
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed