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

NCT06360965 | Recruiting

• 1 other identifier: Shoufa2024-3-7045
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Inflammatory Disease; Chronic Pelvic Pain Syndrome

Keywords

Pelvic Inflammatory Disease; Chronic Pelvic Pain Syndrome; acupoint application; cold dampness stasis type

Outcome Measures

Primary Outcomes (1)

• Main symptoms (lower abdominal pain) improvement level (visual analogue scale)

  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.

  The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).

Secondary Outcomes (5)

• TCM syndrome score scale

  The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

• Local physical sign rating scale

  The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

• Pelvic masses and fluid accumulation

  The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

• EuroQol Five Dimensions Questionnaire

  The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

• Recurrence of abdominal pain during 1-month menstrual cycle was followed up.

  the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

Study Arms (3)

Improved warm meridians and relieve pain plaster group

ACTIVE COMPARATOR

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

Drug: Improved warm meridians and relieve pain plaster

Traditional warm meridians and relieve pain plaster group

ACTIVE COMPARATOR

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.

Drug: Traditional warm meridians and relieve pain plaster

Placebo plaster group

PLACEBO COMPARATOR

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.

Drug: Placebo plaster

Interventions

Improved warm meridians and relieve pain plaster 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.

Improved warm meridians and relieve pain plaster group

Traditional warm meridians and relieve pain plaster DRUG

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

Traditional warm meridians and relieve pain plaster group

Placebo plaster DRUG

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

Placebo plaster group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets the diagnostic criteria of traditional Chinese and Western medicine for sequelae of pelvic inflammatory disease and chronic pelvic pain;
• 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;
• The age range is 18-50 years old, married or with a history of sexual activity;
• Those with a menstrual cycle of 21-35 days;
• points ≤ Pain Visual Analog Scale (VAS) \< 7 points;
• Those who have signed an informed consent form and are willing to receive treatment.

You may not qualify if:

• Female patients who have fertility requirements during pregnancy, lactation, or in the short term;
• Patients with gynecological diseases such as organic lesions of the reproductive system or gynecological acute abdomen;
• Chronic pelvic pain caused by gynecological tumors, endometriosis, pelvic congestion syndrome, uterine fibroids, tuberculous pelvic inflammatory disease, and other diseases confirmed through examination;
• Those with severe diseases such as cardiovascular, cerebrovascular, liver and kidney function, and digestive system;
• Individuals with mental abnormalities and psychological disorders;
• Individuals with allergic constitution or known allergies to the drugs and their components used in this experiment;
• Patients currently participating in clinical trials of other drugs;
• Other methods of treatment have already been or are currently being carried out, which may affect the indicators observed in this study.

Sponsors & Collaborators

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine: lead

Study Sites (1)

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yu Cao, Master

  Beijing Hospital of Integrated Traditional Chinese and Western Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, Master

CONTACT

13811911690; howgreenbreeze@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: January 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)