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Study Comparing Warm Meridians and Pain Relief Patches for Pelvic Inflammatory Disease Sequelae and Chronic Pelvic Pain in Women Aged 18 to 50
Led by Beijing Hospital of Integrated Traditional Chinese and Western Medicine · Updated on 2024-04-11
102
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic Pelvic Pain is a common gynecological symptom characterized by persistent, non-periodic pain in the pelvic area and surrounding tissues. It often occurs as a result of pelvic inflammatory disease that was not treated properly or in time. This research aims to compare the effects of warm meridians and relieve pain plasters in easing symptoms related to the sequelae of pelvic inflammatory disease and chronic pelvic pain, specifically in women with the cold dampness stasis type. The study also evaluates the safety of both improved and traditional patches to support their use in community hospitals. Participants are randomly assigned to one of three groups an improved warm meridians and relieve pain plaster group, a traditional warm meridians and relieve pain plaster group, or a placebo plaster group. Each group applies their assigned acupoint patch to the navel starting from the 1st to 3rd day after menstrual bleeding stops. The patch is worn for 6 to 8 hours before bedtime daily, with one day off, for 10 times per menstrual cycle, completing two consecutive cycles of treatment. The patches contain different herbal mixtures or placebo substances designed to assess therapeutic effects. During the study, participants undergo evaluations at baseline, after two menstrual cycles of treatment about 8 weeks, and during a follow-up period of about 12 weeks. Assessments include pain improvement using a visual analogue scale, traditional Chinese medicine syndrome scores, physical signs, pelvic imaging for masses and fluid, and quality of life questionnaires. Researchers also record any recurrence of abdominal pain and adverse events. The total study duration allows careful monitoring of symptom changes and safety in women aged 18 to 50 years with chronic pelvic pain linked to pelvic inflammatory disease.
CONDITIONS
Brief Title
Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with sequelae of pelvic inflammatory disease and chronic pelvic pain according to traditional Chinese and Western medicine criteria
- Transvaginal ultrasound shows thickened fallopian tube walls and fluid accumulation, possibly with pelvic free fluid or ovarian masses
- Female aged 18 to 50 years, married or with a history of sexual activity
- Menstrual cycle length between 21 and 35 days
- Pain level between 4 and less than 7 on the Visual Analog Scale
- Signed informed consent and willing to receive treatment
You will not qualify if you...
- Women planning pregnancy during pregnancy, lactation, or short term
- Presence of organic reproductive system lesions or gynecological acute abdomen
- Chronic pelvic pain caused by tumors, endometriosis, pelvic congestion syndrome, uterine fibroids, tuberculous pelvic inflammatory disease, or other confirmed diseases
- Severe cardiovascular, cerebrovascular, liver, kidney, or digestive system diseases
- Mental abnormalities or psychological disorders
- Allergic constitution or known allergies to study drugs or components
- Participation in other drug clinical trials
- Ongoing or prior treatments that may affect study observations
Research Team
Y
Yu Cao, Master
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