Endometriosis
Conditions
Interventions
Group of Chinese medicine granule:Yiqi Xiaozheng granules
The placebo group:Placebo granules
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
15 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Patients who met the diagnostic criteria of Chinese and western medicine and TCM syndrome differentiation criteria (qi deficiency and blood stasis type), and had dysmenorrhea symptoms; 2. Patients who were clinically or surgically diagnosed with endometriosis, accompanied by dysmenorrhea, pelvic pain, dyspareunia, and VAS greater than or equal to 3cm 3. Patients who were 15-49 years old, with regular menstrual cycle (23-37 days) and 3-7 days of menstruation. 4 The patient was not pregnant by the urine pregnancy test before enrollment, and contraception was given during the treatment; 5. If the patient takes sex hormone drugs, the drug should be stopped for more than 3 months; 6. Patients who have informed consent and can cooperate to complete the study. For minor patients, informed consent was required from their guardians.
Exclusion criteria
Exclusion criteria: 1. Patients with dysmenorrhea or pelvic pain not caused by endometriosis; Endometriosis patients without dysmenorrhea; Patients with pain caused by endometriosis but VAS score less than 3cm. 2. Women who plan to become pregnant or are pregnant or breastfeeding. 3. Women with other gynecological diseases, such as sequelae of pelvic inflammatory disease and gynecological malignant tumors. 4. Women with serious primary diseases such as diseases in liver, kidney, hematopoietic, cardiovascular and cerebrovascular systems, and malignant tumors;Women with mental system diseases;Women with a history of severe drug allergy or other primary diseases, allergic to Chinese medicine granules, placebo granules or excipients; 5. Women who plan to undergo surgery in the near future or are using other therapeutic methods (such as hormone drugs, GnRH therapy), or have stopped taking western medicine for less than 3 months, or have stopped taking traditional Chinese medicine for less than half a month; 7. Ovarian endometrioma > 5cm or with ovarian solid mass, or single uterine leiomyoma > 5cm; 8. Serum CA125 > 200U/ml; 9. Those who were considered unsuitable for the study by the investigators; Participants who had participated in other clinical trials within 3 months before the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scales;Endometriosis Health Profile EHP-5; | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume of lesion;CA125;Usage of nonsteroidal anti-inflammatory drugs (NSAIDs));Menstruation;TCM syndrome integral scale; | — |
Countries
China
Contacts
Public ContactLiang Xuefang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed