A Randomized Controlled Trial To Assess The Effectiveness Of Individualized Medicine As Compared To Individualized Medicine Along With Viburnum Opulus As An Add On Therapy In The Management Of Pelvic Inflammatory Disease
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in VAS score will be noted for every symptom before, during and after treatment and shall be analysed to assess the efficacy of treatment given.
研究概览
简要总结
A Study is A randomized controlled trial to assess the effectiveness of individualized medicine as compare individualized medicine Viburnum opulus as an add on therapy in the management of pelvic inflammatory disease. Study will be done on 70 patients carried out for 12 months. The out come assessment will be done on the basis of Changes in VAS score will be noted for every symptom and WHO QOL-BREF before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Previously diagnosed cases of PID seeking homoeopathic treatment or newly diagnosed.
- •As per sign & symptoms and CDC (adopted from DC Dutta’s textbook of gynecology 7th edition) Patients with 3-4 confirmatory sign and symptoms given below shall be enrolled for the study irrespective of the diagnosis based on investigations- a.
- •Pelvic pain or lower abdomen pain or back pain.
- •Abnormal & heavy Vaginal discharge (purulent and or copious) c.
- •Offensive vaginal odor.
- •Cervical motion tenderness.
- •Lower abdomen tenderness.
- •Adnexal tenderness.
- •Pruritis vulva.
- •Dyspareunia.
- •Irregular vaginal bleeding.
- •Fever Diagnostic criteria- 1.symptoms as mentioned above.
- •2.USG/ laboratory investigation done if required in case of unclear symptoms given above.
排除标准
- •Cases which required any emergency treatment.
- •Patient pursuing other treatment and were not willing to leave it.
- •Pregnant women and lactating mothers will not be included in the study.
- •5.Cases with multi systemic illness will be excluded from the study and cases with advance pathology & malignancy.
结局指标
主要结局
Changes in VAS score will be noted for every symptom before, during and after treatment and shall be analysed to assess the efficacy of treatment given.
时间窗: Changes in VAS score will be noted for every symptom before, during and after treatment and shall be analysed to assess the efficacy of treatment given at 12 month.
次要结局
- Changes in WHO QOL-BREF scale will be noted for before and after treatment and shall be analysed to assess the efficacy of treatment given .(1year)