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A prospective, randomized, double-blind controlled clinical study of gynecological hot compress in the treatment of primary dysmenorrhea

A prospective, randomized, double-blind controlled clinical study of gynecological hot compress in the treatment of primary dysmenorrhea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057351
Enrollment
Unknown
Registered
2022-03-09
Start date
2022-02-28
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

primary dysmenorrhea

Interventions

Gynecological hot compress group:The gynecological hot compress will be stuck between the umbilicus and pubic symphysis, 2 times a day, 2 hours each time, continuous use for 28 days as a course of tre
Hot compress placebo group:the same as gynecological hot compress

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. It conforms to the diagnosis of primary dysmenorrhea in western medicine; 2. The VAS score of abdominal pain on the most painful day before menstruation or during menstruation in the last 3 months is = 4 points; 3. Symptoms of dysmenorrhea occurred continuously before or on the day of menstruation in recent 3 months; 4. Regular menstrual cycle: 21-35 days; menstrual period: 3-7 days; 5. Aged 16-35 (inclusive); 6. Voluntary participation in this clinical trial, informed consent and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary dysmenorrhea caused by endometriosis, adenomyosis, pelvic inflammatory diseases, etc; 2. Have used pain relievers such as non steroidal anti-inflammatory drugs or other methods to treat dysmenorrhea in the past month; 3. I have used traditional Chinese medicine and Chinese patent medicine with the function of regulating qi and removing blood stasis in the past month; 4. Blood creatinine (SCr)>upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 1.5 times of upper limit of normal reference value, or hemoglobin = 90g/L; 5. Gynecological tumor, hysteromyoma, abortion history, and gynecological surgery history; 6.6 Use of injectable or subcutaneous implantation of long-acting contraceptives within six months, or use of contraceptives and drug intrauterine devices within eight weeks, or preparation for pregnancy and pregnancy or lactation within six months; 7. Have bleeding tendency; 8. Complicated with serious primary diseases such as heart, brain, lung, liver, kidney, nervous system and hematopoietic system; 9. Mental retardation or psychosis or neurosis; 10. Suspect or have a history of alcohol and drug abuse; 11. Known or suspected to have a history of allergy to the ingredients and excipients of the test drug; 12. Asthma patients who are allergic to ibuprofen capsules or other non steroidal anti-inflammatory drugs or aspirin for emergency use; 13. Participated in other clinical trials in recent 3 months; 14. The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Secondary

MeasureTime frame
11/5000 VAS score for dysmenorrhea;Duration of dysmenorrhea;The number of days with significant menstrual pain VAS=4;CMSS Score;

Primary

MeasureTime frame
Dysmenorrhea pain relief rate;

Countries

China

Contacts

Public ContactYu Chaoqin

Naval Medical University

chqyu81@163.com+86 13818390984

Outcome results

None listed

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