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

NCT ID: NCT06360965

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Pelvic Inflammatory Disease; Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Improved warm meridians and relieve pain plaster group

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

Group Type: ACTIVE_COMPARATOR

Improved warm meridians and relieve pain plaster

Intervention Type: DRUG

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 group

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.

Group Type: ACTIVE_COMPARATOR

Traditional warm meridians and relieve pain plaster

Intervention Type: DRUG

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

Placebo plaster group

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.

Group Type: PLACEBO_COMPARATOR

Placebo plaster

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Traditional warm meridians and relieve pain plaster

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

Intervention Type: DRUG

Placebo plaster

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Cao, Master

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Locations

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Cao, Master

Role: CONTACT

howgreenbreeze@126.com

13811911690

Facility Contacts

YuNa Liu

Role: primary

kjk882236672@163.com

86-010-88223667

Other Identifiers

Shoufa2024-3-7045

Identifier Type: -

Identifier Source: org_study_id