Dysmenorrhea
Conditions
Interventions
Intervention group:Take 4 GeneIII L-Ergothioneine Capsules daily (two capsules in the morning and two capsules in the evening) for three consecutive menstrual cycles.
Placebo Group:Take 4 placebo capsules daily (two capsules in the morning and two capsules in the evening) for three consecutive menstrual cycles.
Sponsors
Qingdao Central Hospital,University of Health and Rehabilitation Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Unmarried or nulliparous females aged 18-35 years (inclusive). 2. Meet the diagnostic criteria for primary dysmenorrhea: (1) Primary dysmenorrhea is common in adolescence, often occurring within 1-2 years after menarche. (2) Pain usually begins with the onset of menstrual bleeding, earliest appearing 12 hours before menstruation, peaks in severity on the first day of menstruation, and lasts for 2-3 days before alleviating. The pain is often cramping and located in the lower abdomen suprapubically, potentially radiating to the lumbosacral region and inner thighs. (3)May be accompanied by symptoms such as nausea, vomiting, diarrhea, dizziness, and fatigue; severe cases may present with pallor and cold sweats. (4)Gynecological examination reveals no abnormal findings. Clinical diagnosis is based on lower abdominal cramping pain during menstruation, absence of positive signs on gynecological examination, and exclusion of organic lesions by ultrasound. Diagnosis requires differentiation from secondary dysmenorrhea caused by endometriosis, adenomyosis, or pelvic inflammatory disease. 3. Regular menstrual cycles (28 +/- 7 days). 4. A recalled Visual Analog Scale (VAS) score for pain of >=4 points for at least three consecutive menstrual cycles. 5. Willing and able to accept the treatment, observation, and all required examinations. 6. Voluntarily agrees to participate in the study after being informed of its content and signs an Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with severe primary diseases involving the cardiovascular, hepatic, renal, pulmonary, biliary, or hematopoietic systems; patients with malignant tumors; or patients with psychiatric disorders. 2. Patients with a highly allergic constitution, or those with known allergies to any component of the investigational product or for whom it is deemed unsuitable. 3. Use of NSAIDs, traditional Chinese medicine, or other treatments for dysmenorrhea within the past month. 4. Pregnant or lactating women. 5. History of alcohol abuse (defined as consumption of more than 14 units of alcohol per week, where 1 unit ˜ 285 mL of beer, 25 mL of spirits of 40% alcohol by volume, or 100 mL of wine) or substance abuse. 6. Any of the following laboratory findings at screening: (1) Hemoglobin (Hb) 2 times the upper limit of normal (ULN); (5) Serum creatinine > 1.5 times ULN; (6) Uncontrolled blood glucose (random blood glucose level > 11.1 mmol/L during screening despite the use of hypoglycemic agents). 7. Uncontrolled hypertension at screening (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after the use of antihypertensive medications). 8. Participation in any other drug clinical trial or interventional study within the past month. 9. Patients considered by the investigator to be unsuitable for clinical trial participation or unable to complete the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS Score;Dysmenorrhea Symptom Score;COX Menstrual Symptom Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory Factors;The quantity and dimensions of breast nodules; | — |
Countries
China
Contacts
Public ContactLiu Fengjuan
Qingdao Central Hospital,University of Health and Rehabilitation Sciences
Outcome results
None listed