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Clinical Trials/ChiCTR1900022732
ChiCTR1900022732CompletedPhase 4

评价抗妇炎胶囊治疗盆腔炎性疾病后遗症-慢性盆腔痛有效性、安全性的随机、双盲、阳性药对照、多中心临床试验

贵州远程制药有限责任公司9 sites in 1 country240 target enrollmentStarted: September 30, 2014Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
240
Locations
9
Primary Endpoint
主要症状（下腹胀痛或刺痛）改善程度
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

1.通过观察视觉模拟量化评分（VAS）和疾病综合评分的变化，评价抗妇炎胶囊对盆腔炎性疾病后遗症-慢性盆腔痛主要症状（下腹胀痛或刺痛）和局部体征的改善作用； 2.通过观察湿热下注、瘀血阻络证量化评分、单项症状和体征、生活质量量表评分（EQ-5D）的前后变化，评价抗妇炎胶囊对中医证候（湿热下注、瘀血阻络证）和生活质量的改善作用； 3.通过观察妇科阴道彩超治疗前后的变化，探索抗妇炎胶囊对盆腔包块和积液的改善作用； 4.通过随访主要症状（下腹胀痛或刺痛）痊愈患者，探索抗妇炎胶囊对慢性盆腔痛复发的预防作用； 5.观察抗妇炎胶囊治疗盆腔炎性疾病后遗症-慢性盆腔痛临床用药的安全性；

Study Design

Study Type
干预性研究
Primary Purpose
随机平行对照
Masking
双盲

Eligibility Criteria

Ages
20 to 50 (—)
Sex
Female

Inclusion Criteria

  • •1.符合盆腔炎性疾病后遗症诊断标准，慢性盆腔痛持续 6 个月以上；
  • •2.符合中医辨证属湿热下注、瘀血阻络证诊断标准者；
  • •3.年龄 20～50 岁的女性，已婚或有性生活史者；
  • •4.月经周期为 28～35 天者；
  • •5.慢性盆腔痛疼痛程度（VAS）评分≥4；
  • •6.受试者知情同意，志愿受试，获得知情同意过程符合 GCP 规定。

Exclusion Criteria

  • •1.妊娠、半年之内准备妊娠或哺乳期妇女；
  • •2.经检查证实由妇科肿瘤（子宫肌瘤最大直径大于 3cm 及粘膜下肌瘤）、滴虫性阴道炎、外阴阴道假丝酵母菌病、细菌性阴道病、急性宫颈炎、盆腔炎性疾病、子宫内膜异位症、子宫腺肌病、盆腔静脉瘀血综合征、间质性膀胱炎（IC）等其它病症引起的相关症状者；
  • •3.血清 CA-125≥35U/ ml，血沉＞25mm/h（魏氏法）者；
  • •4.合并有心血管、肝、肾和血液系统等严重原发性疾病、精神病患者，其中血 ALT、AST＞正常上限，血肌酐(Cr)＞正常上限者；
  • •5.2 周内实施过相关治疗并服用功能主治相似的药物者；
  • •6.正在参加其他临床试验或近 1 个月内使用抗生素治疗的患者；
  • •7.过敏体质或已知对本试验中所用药物及其成分过敏者；
  • •8.法律规定的残疾患者（盲、聋、哑、智力障碍、精神障碍、肢体残疾）；
  • •9.怀疑或确有酒精、药物滥用病史者。

Arms & Interventions

试验组

抗妇炎胶囊

对照组

宫炎平胶囊

Outcomes

Primary Outcomes

主要症状（下腹胀痛或刺痛）改善程度

疾病疗效

Secondary Outcomes

  • 中医证候疗效
  • 各单项症状、局部体征评分变化情况
  • EQ-5D 各维度评分
  • 随访 1 个月经周期下腹疼痛复发情况
  • 盆腔包块和积液用药后改变情况

Investigators

Study Sites (9)

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