Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain

NCT06360965 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Phase

Not applicable

Started

2024-01-01

Last updated

2024-04-11

Condition(s) studied

Pelvic Inflammatory DiseaseChronic Pelvic Pain Syndrome

Investigational drug(s) / intervention(s)

Improved warm meridians and relieve pain plasterTraditional warm meridians and relieve pain plasterPlacebo plaster

Improved warm meridians and relieve pain plaster: Starting from the 1st to 3rd day after the menstrual cycle is clean, apply it 6-8 hours before bedtime every day, with one day off. Apply 10 times per menstrual cycle as one course of treatment, with two consecutive courses of treatment.

Traditional warm meridians and relieve pain plaster: The treatment course is the same as the improved warm meridians and relieve pain plaster group.

Placebo plaster: The treatment course is the same as the improved warm meridians and relieve pain plaster group.

Study summary

Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: 1. Meets the diagnostic criteria of traditional Chinese and Western medicine for sequelae of pelvic inflammatory disease and chronic pelvic pain; 2. Transvaginal ultrasound examination shows thickening of the fallopian tube wall and fluid accumulation in the lumen, which may be accompanied by pelvic free fluid or fallopian tube ovarian masses; 3. The age range is 18-50 years old, married or with a history of sexual activity; 4. Those with a menstrual cycle of 21-35 days; 5. 4 points ≤ Pain Visual Analog Scale (VAS) \< 7 points; 6. Those who have signed an informed consent form and are willing to receive treatment. Exclusion Criteria: 1. Female patients who have fertility requirements during pregnancy, lactation, or in the short term; 2. Patients with gynecological diseases such as organic lesions of the reproductive system or gynecological acute abdomen; 3. Chronic pelvic pain caused by gynecological tumors, endometriosis, pelvic congestion syndrome, uterine fibroids, tuberculous pelvic inflammatory disease, and other diseases confirmed through examination; 4. Those with severe diseases such as cardiovascular, cerebrovascular, liver and kidney function, and digestive system; 5. Individuals with mental abnormalities and psychological disorders; 6. Individuals with allergic constitution or known allergies to the drugs and their components used in this experiment; 7. Patients currently participating in clinical trials of other drugs; 8. Other methods of treatment have already been or are currently being carried out, which may affect the indicators observed in this study.

Primary outcome measure(s)

Main symptoms (lower abdominal pain) improvement level (visual analogue scale) — The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).
Using the Visual Analog Scale (VAS), draw a 10cm thick straight line on the patient record card, with one end indicating no pain and the other end indicating unbearable severe pain. Patients should mark a point on the line based on the degree of lower abdominal pain (bloating or stabbing) they experience. Researchers use a straightedge to measure the straight-line distance from the starting point to the patient's designated point, and express the intensity of pain using the measured numbers. Record the specific mm measured by the patient.

Trial sites (1)

Facility	City	Region	Status
Beijing Hospital of Integrated Traditional Chinese and Western Medicine	Beijing	China	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360965 on ClinicalTrials.gov ↗ ← All trials in China