Clinical trial
A Randomized Controlled Trial on the Clinical Efficacy and Safety of Warm Meridians and Relieve Pain Plaster in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain (Cold Dampness Stasis Type).
Name
Shoufa2024-3-7045
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2026-03-31
Trial end
2026-12-31
Status
Recruiting
Treatment
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.
Arms:
Improved warm meridians and relieve pain plaster group
Traditional warm meridians and relieve pain plaster
The treatment course is the same as the improved warm meridians and relieve pain plaster group.
Arms:
Traditional 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.
Arms:
Placebo plaster group
Size
102
Primary endpoint
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).
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 102, 'type': 'ESTIMATED'}}
Updated at
2024-04-11
1 organization
3 products
2 indications
Indication
Pelvic Inflammatory DiseaseIndication
Chronic Pelvic Pain SyndromeProduct
Placebo plaster