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

Официальное название

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).

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Main symptoms (lower abdominal pain) improvement level (visual analogue scale) [Срок оценки: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks).]

Вторичные конечные точки (5)

• TCM syndrome score scale [Срок оценки: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .]
• Local physical sign rating scale [Срок оценки: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .]
• Pelvic masses and fluid accumulation [Срок оценки: The baseline period, the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .]
• EuroQol Five Dimensions Questionnaire [Срок оценки: 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. [Срок оценки: the treatment two menstrual cycle (about 8 weeks) and the follow-up period (about 12 weeks) .]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine — Пекин

Идентификаторы

NCT: NCT06360965 · Shoufa2024-3-7045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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