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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Main symptoms (lower abdominal pain) improvement level (visual analogue scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Improved warm meridians and relieve pain plaster (Drug)
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.
干预措施: Traditional warm meridians and relieve pain plaster (Drug)
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.
干预措施: Placebo plaster (Drug)
结局指标
主要结局
Main symptoms (lower abdominal pain) improvement level (visual analogue scale)
时间窗: 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.
次要结局
- 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) .)
- 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) .)