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

April 6, 2024 updated by: Beijing Hospital of Integrated Traditional Chinese and Western Medicine

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Hospital of Integrated Traditional Chinese and Western Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: 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.
Active Comparator: 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.
Drug: Traditional warm meridians and relieve pain plaster
The treatment course is the same as the improved warm meridians and relieve pain plaster group.
Placebo Comparator: 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.
Drug: Placebo plaster
The treatment course is the same as the improved warm meridians and relieve pain plaster group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Main symptoms (lower abdominal pain) improvement level (visual analogue scale)
Time Frame: 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.
The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TCM syndrome score scale
Time Frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
The TCM syndrome score scale consists of three main symptoms and nine secondary symptoms. The main symptoms included abdominal pain, lumbosacral pain and subzonal pain, with scores of 0, 2, 4 and 6 according to the severity. Secondary symptoms include menstrual abdominal pain, fear of cold , loss of appetite, menstrual color, stool, urination, tongue and pulse, etc., tongue and pulse records do not score, other items are given 0, 1, 2, 3 points according to the situation. The higher the total score, the more severe the symptoms.
The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Local physical sign rating scale
Time Frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Local physical sign rating scale included limitation of uterine activity and tenderness, thickening of bilateral appendages and mass, tenderness of bilateral appendages and thickening of uterine-sacral ligament. The score was 0-6. The higher the total score, the more severe the symptoms.
The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Pelvic masses and fluid accumulation
Time Frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Pelvic mass was evaluated according to pelvic ultrasound. The original mass disappeared as disappeared; the original mass volume shrank by more than 2/3 compared with that before treatment as significantly reduced; the original mass volume shrank by 1/3-2/3 compared with that before treatment as reduced; the original mass remained unchanged or increased as unchanged or increased. Pelvic fluid was evaluated according to pelvic ultrasound. The original fluid disappeared as disappeared; the original fluid area reduced by more than 2/3 compared with that before treatment as significantly reduced; the original fluid area reduced by 1/3-2/3 compared with that before treatment as reduced; the original fluid remained unchanged or increased as unchanged or increased.
The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
EuroQol Five Dimensions Questionnaire
Time Frame: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
The EQ-5D mainly consists of two parts: the EQ-5D Descriptive System and the EQ-5D Visual Analog Scale . In the description section, the EQ-5D will describe the health status in five dimensions: Mobility, Self care, UsualActivities, Pain/Discomfort, and Anxiety/Depression. The questionnaire requires respondents to choose the most suitable option for themselves in each dimension based on their health status. In the evaluation section, respondents used the Visual Analog Scale (EQ-VAS) to assess their overall health status. EQ-VAS records the self rated health status of respondents on a vertical scale. The scale of the ruler is 0-100, where 0 represents "the worst health state you imagine" and 100 represents "the best health state you imagine". The self-assessment information of the respondents can be used as a quantitative indicator of health outcomes.
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.
Time Frame: the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Within 1 menstrual cycle after treatment, patients with the main symptom "pain or tingling of lower abdomen" (VAS score was "0") were followed up, and the end point of follow-up was the recurrence point of the main symptoms. If there was no recurrence in one menstrual cycle after the end of treatment, it was the end point of follow-up.
the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yu Cao, Master, Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shoufa2024-3-7045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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