Pelvic Inflammatory DiseaseNCT06360965

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

A study testing Improved warm meridians and relieve pain plaster and Traditional warm meridians and relieve pain plaster in people with Pelvic Inflammatory Disease and Chronic Pelvic Pain Syndrome, run by Beijing Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Pelvic Inflammatory Disease, Chronic Pelvic Pain Syndrome
What is being tested?: Improved warm meridians and relieve pain plaster and Traditional warm meridians and relieve pain plaster
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteChina
Study dates: 1 Jan 2024to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

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;
4 points ≤ Pain Visual Analog Scale (VAS) < 7 points;
Those who have signed an informed consent form and are willing to receive treatment.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu Cao, Master contact

13811911690

howgreenbreeze@126.com

China1 site, 1 recruiting

Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Beijing
YuNa Liu, 86-010-88223667, kjk882236672@163.com
Recruiting

Other trials in China

About this study

Official title: 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).

Read the 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
Being tested: Improved warm meridians and relieve pain plaster, Traditional warm meridians and relieve pain plaster, Placebo plaster
Keywords: Pelvic Inflammatory Disease, Chronic Pelvic Pain Syndrome, acupoint application, cold dampness stasis type
Medical subject headings: Pelvic Inflammatory Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06360965
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Placebo plaster

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 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.
Measured: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Local physical sign rating scale
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.
Measured: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
Pelvic masses and fluid accumulation
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.
Measured: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .
EuroQol Five Dimensions Questionnaire
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.
Measured: 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.
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.
Measured: the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2026

First posted11 Apr 2024
Study start1 Jan 2024
Primary completion31 Mar 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 102 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06360965
Sponsor's protocol ID: Shoufa2024-3-7045
Status last verified: Apr 2024
First submitted: 1 Apr 2024
Last updated: 11 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Yu Cao, Master

13811911690

howgreenbreeze@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Pelvic Inflammatory Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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).
ClinicalTrials.gov ID: NCT06360965
Acronym / sponsor ID: Shoufa2024-3-7045
Conditions: Pelvic Inflammatory Disease, Chronic Pelvic Pain Syndrome
Keywords: Pelvic Inflammatory Disease, Chronic Pelvic Pain Syndrome, acupoint application, cold dampness stasis type
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 102 participants (estimated)
Lead sponsor: Beijing Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Mar 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 11 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Improved warm meridians and relieve pain plaster group	Active comparator	Drug: Improved warm meridians and relieve pain plasterUse an improved warm meridians and relieve pain plaster (about 7cm wide, 10cm long, and 0.5mm thick) to apply to the navel.
Traditional warm meridians and relieve pain plaster group	Active comparator	Drug: Traditional warm meridians and relieve pain plasterSelect 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.
Placebo plaster group	Placebo comparator	Drug: Placebo plasterTake 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.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;
4 points ≤ Pain Visual Analog Scale (VAS) < 7 points;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Improved warm meridians and relieve pain plasterStarting 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.	Drug	Improved warm meridians and relieve pain plaster group
Traditional warm meridians and relieve pain plasterThe treatment course is the same as the improved warm meridians and relieve pain plaster group.	Drug	Traditional warm meridians and relieve pain plaster group
Placebo plasterThe treatment course is the same as the improved warm meridians and relieve pain plaster group.	Drug	Placebo plaster group

Primary outcome

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.

5 secondary outcomes

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) .
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) .
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) .
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) .
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) .

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.

Related trials for Pelvic Inflammatory Disease

Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
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RecruitingPhase 1/2
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Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yu Cao, Master contact

13811911690

howgreenbreeze@126.com

Yu Cao, Master principal investigator

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yu Cao, Master (13811911690, howgreenbreeze@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06360965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.