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

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Status: Enrolling

Conditions: Pelvic Inflammatory Disease; Chronic Pelvic Pain Syndrome

Treatments: Drug: Traditional warm meridians and relieve pain plaster; Drug: Improved warm meridians and relieve pain plaster; Drug: Placebo plaster

Study type: Interventional

Funder types: Other

Identifiers

NCT06360965

Shoufa2024-3-7045

Details and patient eligibility

About

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.

Full 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. Chronic pelvic pain is mainly characterized by lower abdominal or lumbosacral pain, which may be accompanied by increased vaginal discharge. This disease has the characteristics of high incidence rate, long course, lingering, difficult to heal, easy to relapse, etc., which seriously affects women's reproductive health and quality of life, and increases the family and socio-economic burden. At present, there is no effective treatment method in Western medicine for the sequelae of pelvic inflammatory diseases and chronic pelvic pain, mainly targeting the symptoms of patients for treatment. Therefore, this study selected 102 patients with pelvic inflammatory disease sequelae and chronic pelvic pain (cold dampness stasis type) who met the inclusion criteria as the research subjects. They were randomly divided into an improved warm meridians and relieve pain plaster group, a traditional warm meridians and relieve pain plaster group, and a placebo group. Three groups of acupoint patches were applied to the navel, and the therapeutic effect was evaluated after two consecutive menstrual cycles. Follow up was conducted at the end of one menstrual cycle after the treatment, and adverse events during the research process were recorded. Compare the effectiveness of warm meridians and relieve pain plaster in relieving symptoms of this disease, and evaluate the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 3 patient groups, including a placebo group

Improved warm meridians and relieve pain plaster group

Active Comparator group

Description:

Use an improved warm meridians and relieve pain plaster (about 7cm wide, 10cm long, and 0.5mm thick) to apply to the navel.

Treatment:

Drug: Improved warm meridians and relieve pain plaster

Traditional warm meridians and relieve pain plaster group

Active Comparator group

Description:

Select Angelica sinensis, Ligusticum chuanxiong, Cinnamon, Sichuan pepper, Corydalis yanhusuo, Fructus Evodiae, Paeonia lactiflorus, Artemisia argyi, Cyperus, Zelan, and Muxiang, mix in a ratio of 1.5:1:1.8:1.5:1.2:0.5:1.5:0.8:1.5:1.5, and use a grinder to grind and sieve; Take an appropriate amount of Vaseline and mix thoroughly with the above-mentioned powder in a 1:1 ratio. Take an appropriate amount of medication and place it in the center of the acupoint patch (8cm x 8cm). Press the medication evenly into a circular hole with a diameter of about 4cm and a depth of about 3mm, and align the patch.

Treatment:

Drug: Traditional warm meridians and relieve pain plaster

Placebo plaster group

Placebo Comparator group

Description:

Take an appropriate amount of Vaseline and mix thoroughly with 1% of the original ingredient, starch, and pigment. Take an appropriate amount of medication and place it in the center of the acupoint patch (8cm x 8cm). Press the medication evenly into a circular hole with a diameter of about 4cm and a depth of about 3mm, and align the patch.

Treatment:

Drug: Placebo plaster