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Clinical randomized controlled trial of dingkundan oral liquid in the treatment of primary dysmenorrhea

Clinical randomized controlled trial of dingkundan oral liquid in the treatment of primary dysmenorrhea

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045204
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

Primary dysmenorrhea of cold coagulation and blood stasis type

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Patients met the diagnostic criteria of "consensus guideline for primary dysmenorrhea of SOGC 2017"; 2. According to the syndrome differentiation standard of "cold coagulation and blood stasis syndrome"; 3. Patients aged between 18 and 30 years who have not given birth (need contraception during medication); 4. The former menstrual cycle was regular (28 ± 7 days); 5. Vas (Visual analog pain score) >= 4; 6. Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary dysmenorrhea caused by endometriosis, adenomyosis and pelvic inflammatory disease; 2. Patients who use intrauterine device and plan pregnancy within 6 months; 3. Patients who used long-acting contraceptives by injection or subcutaneous implantation within 6 months, or who took oral contraceptives for less than 8 weeks were in washout period; 4. There are serious primary heart, liver, lung, kidney, blood or other serious diseases affecting survival, such as tumor; 5. Disabled patients stipulated by law (deaf, dumb, blind, mental retardation, spermatic impairment); 6. Suspected or history of drug or alcohol abuse; 7. Allergic weight, allergic to two or more drugs or food, or allergic to known components of the drug; 8. Patients who are participating in clinical trials of other drugs; 9. Patients with other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, unstable living environment, etc., which are likely to cause loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Degree of abdominal pain during menstruation (VAS score);

Secondary

MeasureTime frame
CMSS scale (Cox dysmenorrhea symptom scale);TCM syndrome integral scale;Serum related indexes;Blood flow of bilateral uterine arteries in serum prostaglandins;

Countries

China

Contacts

Public ContactMa Kun

Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine

makun12348@sina.com+86 13910218105

Outcome results

None listed

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