A Randomized, Double-blind, Positive-Controlled Study to Evaluate the Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Improvement in Visual Analog Scale (VAS) for pain assessment
研究概览
简要总结
Randomized, double blind and positive-controlled clinical trial to assess the efficacy and safety of Fuke Qianjin Capsule compared to Doxycycline Hyclate Tablet in patients with mild to medium PID and its sequalae.
详细描述
Study participants will be randomly assigned to Test or Control group and the following schedule will be followed
Test group: metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.
Control group: metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.
Fuke Qianjin Capsules and their simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet and their simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.
Scoring pain, symptoms, local signs, routine leucorrhea, cervical secretions, gynaecological B-ultrasound will be examined before the enrollment and after study completion.
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
- Double (Participant, Investigator)
盲法说明
Participant and investigator both are blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-
- •History of sexual life.
- •Consistent with the diagnosis of pelvic inflammatory disease.
- •VAS score ≥
- •Voluntarily participate in the clinical trial and signed the Informed Consent form obtained before any trial-related procedures are performed
排除标准
- •Patients with severe pelvic inflammatory disease, or patients with dizziness, vomiting, high fever; pelvic abscess; fallopian tube ovarian abscess, etc.
- •Absence of uterus.
- •Patients with gynaecological tumors (uterine fibroids > 5 cm in diameter, submucosal fibroids), specific vaginitis, adenomyosis, endometriosis, pelvic venous stasis, tuberculous pelvic inflammatory disease, abnormal uterine bleeding, etc. confirmed by examination, and related symptoms caused by other diseases.
- •Patients with serious primary diseases of the heart, liver, kidney, hematopoietic system and those who have an impact on clinical trial as judged by the investigator.
- •Patients with neurological and psychiatric disorders and unable or unwilling to cooperate.
- •Allergic (allergic to two or more substances) or allergic to the components of this medicine; Suspected or indeed history of allergy to tetracyclines.
- •Pregnant and breastfeeding women.
- •Treated with similar drugs in the past 2 weeks.
- •Those who are participating in or have participated in other clinical trials in the past 3 months.
- •Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that may reduce the possibility or complicate enrolment according to the judgment of the investigator, such as frequent changes in work environment and unstable living environment, which may easily lead to loss of follow-up.
研究组 & 干预措施
Fuke Qianjin capsule
Metronidazole tablets + Doxycycline Hyclate tablets simulant are consecutively taken for 14 days, while the Fuke Qianjin capsule is consecutively taken for 28 days.
Fuke Qianjin Capsules are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch, and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.
干预措施: Control Group (Drug)
Metronidazole tablets + Doxycycline hyclate tablets
Metronidazole tablets + Doxycycline hyclate tablets are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.
Fuke Qianjin Capsules simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively.
干预措施: Test Group (Drug)
结局指标
主要结局
Improvement in Visual Analog Scale (VAS) for pain assessment
时间窗: after 28 days of treatment
Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment the pain will be assessed as 0 is painless, 10 is extremely painful. Patients will mark in the corresponding position according to the degree of pain, and the researcher will give a specific score. The grading criteria of Pelvic pain with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.
次要结局
- Assessment of changes in main clinical Symptom(after 28 days of treatment)
- gynaecological B-ultrasound(after 28 days of treatment)
研究者
Dr. Muhammad Raza Shah
Professor
University of Karachi