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Randomized Controlled Trial and Transcriptomic Mechanism Study of Dysmenorrhea Prescription in the Treatment of Primary Dysmenorrhea with Cold Coagulation and Blood Stasis Syndrome

Randomized Controlled Trial and Transcriptomic Mechanism Study of Dysmenorrhea Prescription in the Treatment of Primary Dysmenorrhea with Cold Coagulation and Blood Stasis Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001748
Enrollment
Unknown
Registered
2026-07-16
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Interventions

Experimental group (Dysmenorrhea Prescription group):Traditional Chinese medicine
Control Group (Ibuprofen Group):Ibuprofen

Sponsors

Sanming Hospital of Integrated Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1.Meet the Western medical diagnostic criteria for primary dysmenorrhea; 2.Conform to the TCM syndrome differentiation criteria of cold coagulation and blood stasis syndrome; 3.Unmarried females aged 13 to 35 years old; 4.Visual Analogue Scale (VAS) score for pain = 40mm; 5.Regular menstrual cycles in the recent 3 months; 6.Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Secondary dysmenorrhea; 2.Contraindications to the use of NSAIDs; 3.Allergy to ibuprofen or ingredients in dysmenorrhea prescriptions; 4.Use of hormonal drugs or other Chinese and Western medicines for treating dysmenorrhea within the past month; 5.Women preparing for pregnancy, pregnant or breastfeeding; 6.Complicated with severe cardiovascular, hepatic, renal, hematopoietic system diseases or mental illnesses

Design outcomes

Primary

MeasureTime frame
Dysmenorrhea VAS Score;

Secondary

MeasureTime frame
TCM Syndrome Score;Cox Menstrual Pain Symptom Scale;SF-36 Quality of Life Scale;Usage of Emergency Painkillers;Recurrence rate;Peripheral blood prostaglandins (PGF2a, PGE2);

Countries

China

Contacts

Public ContactChunmei Qiu

Sanming Hospital of Integrated Medicine

qz703qz@163.com13700183977

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026