Effect of Yishenxiaozheng Granule on resting state insula function network of dysmenorrhea caused by endometriosis

Phase 1

Recruiting

• Conditions: Endometriosis

• Registration Number: ITMCTR2000004057
• Lead Sponsor: Dongfang Hospital of Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for dysmenorrhea patients with endometriosis:
1. Patients with EM diagnosis;
2. Patients with dysmenorrhea symptom score >= 7.5 according to the guiding principles for clinical research of new drugs of traditional Chinese medicine (1993);
3. Patients with kidney deficiency and blood stasis syndrome in TCM;
4. Patients with age >= 20 and <= 45 years old;
5. Subjects with elevated serum CA125 (i.e. higher than the upper limit of normal value);
6. Right handedness patients were assessed by oldfriedls Edinburgh Handedness scale;
7. There is no contraindication of MRI in patients without metal implants;
8. Subjects who signed informed consent voluntarily.
Patients with EM dysmenorrhea who meet all the above inclusion criteria will be considered.
Inclusion criteria for healthy subjects:
1. Subjects aged >= 20 and <= 45 years;
2. After physical examination, the subjects whose physiological indexes were in the normal range had no previous functional or organic diseases, no head injury and no dysmenorrhea symptoms;
3. Right handedness subjects were assessed by oldfriedls Edinburgh Handedness scale;
4. For those subjects without metal implants in vivo, there was no MRI contraindication;
5. Subjects who voluntarily signed informed consent. Healthy people meeting all the above inclusion criteria will be considered for inclusion.

Exclusion Criteria

Exclusion criteria for dysmenorrhea patients with endometriosis
1. Patients with ovarian malignant tumor, pelvic inflammatory mass, adenomyosis, hysteromyoma > 4cm, primary dysmenorrhea, or women with IUD;
2. Patients who have used drugs or other therapies for endometriosis in recent 3 months (including laparoscopy);
3. Patients with ovarian chocolate cyst diameter > 5cm;
4. Patients with hemoglobin < 90g / L;
5. Patients with severe cardiovascular disease and liver disease: Patients with ALT and AST > the upper limit of normal value, kidney disease; patients with bun and SCR > the upper limit of normal value, diabetes mellitus;
6. Patients with allergic constitution or allergic to the test drug;
7. Patients who should pay attention to ibuprofen sustained release capsules include gastrointestinal diseases, renal insufficiency, hypertension, cardiac insufficiency, peptic ulcer, hemophilia or other hemorrhagic diseases (including coagulation or platelet dysfunction) and bronchial asthma;
8. Patients who took painkillers, sedatives, tea and coffee within 24 hours before MRI examination and had nausea and vomiting before MRI examination;
9. Pregnant or lactating women who have fertility requirements in the past six months;
10. Patients considered unsuitable by doctors to participate in clinical trials.
All patients with EM dysmenorrhea in accordance with any of the above items were excluded.
Exclusion criteria for healthy subjects:
1. Pregnant or lactating women who have fertility requirements in the past six months;
2. Subjects who have taken excitatory drugs in the past 3 months;
3. Subjects who have received traditional Chinese medicine treatment in the past three months;
4. Subjects who are participating in other clinical trials.
Those who meet any of the above criteria are excluded.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified