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Metabolomics study of primary dysmenorrhea patients and the intervetion effects of Siwu series formulae (Shaofu Zhuyu formula)

The clinical trial protocol of Siwu series formulae (Shaofu Zhuyu formula) for treating primary dysmenorrhea

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002278
Enrollment
Unknown
Registered
2012-06-06
Start date
2010-10-22
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

primary dysmenorrhea

Interventions

1:shaofu zhuyu formula

Sponsors

Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion: age 18-40 years, dysmenorrhea in the last three periods with an average score higher than 4 on Visual-Analog Scale (VAS) for pain (the VAS assessment method is used), regular menstrual cycles for at least 3 months, and no history of gynecologic disease. All patients must met Diagnostic Code of Primary Dysmenorrhea (1993 Edition, the National Ministry of Health, China) and Criteria of Diagnosis and therapeutic effect of traditional Chinese medicine disease (State Administration of TCM approved).

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for all patients were endometriosis, leiomyomata (fibroids), adenomyosis, pelvic inflammatory disease, and intrauterine device (IUD); age above 40 years; 2. not belonging to the syndrome of cold coagulation and blood stasis; 3. with cardiovascular, liver, kidney, hyperlipidemia, hypertension, or mental diseases through history or evaluation at the screening visit.

Design outcomes

Primary

MeasureTime frame
PGE2, PGF2a;5-HT;OT;arg8-Vasopressin;E2;P;follicle-stimulating hormone;testosterone;glucocorticoid;LTB4;nitric Oxide;endothelin-1;lipoprotein (a);routine blood test;routine urine test;blood flow rheomete;

Countries

China

Contacts

Public ContactDuan Jin-ao
duanja@163.com+86 25 85811116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026