A comparative clinical study to evaluate the effect of Brihtyadi Ghan vati with Laghu Panchmoola kwath prakshalan and taila pichu in Paripluta Yonivyapad wsr PID
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness
研究概览
简要总结
The study is entitled as" A comparative clinical study to evaluate the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and taila pichu in paripluta yonivyapad w.s.r PID
Objective of study- To compare the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and Brihtyadi Ghan vati with laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu in management of paripluta yonivyapad w.s.r PID
Type of study-Randomised comparative parallel open clinical trial
Administration of trail therapy- Minimum 40 patients having cardinal symptoms of paripluta yonivyapad
Group allocation- Registered patients will be randomly divided into two groups
Group A-Brihtyadi Ghan vati 2 BD (500mg) with water for 21 day and laghu panchmoola kwath prakshalan for 7 day (after clearness of menses)
Group B- Brihtyadi Ghan vati 2 BD ( 500mg) with water and laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu for 7 day (after clearness of menses)
Duration of trail- 3 consecutive cycle
Follow up during treatment- 3 follow up will be done at every 1month during the therapy
Follow up after the treatment- fourth follow up will be done after 1month of the completion of the trail ( without medicine)
Criteria for the selection patients
Diagnostic criteria-
1.Lower abdomen pain
2.Low back pain
3.Abnormal vaginal discharge
4.Dyspareunia
5.Cervical motion tenderness or adnexal/Fornix tenderness
6.USG report having suggestive finding PID
When 3 and more criteria is fulfilled that it’s said to patients of PID
Assessment criteria-
Subjective criteria-
•Sparshakshama (Tenderness)
•Vedna in shroni vankshan ( pain in lower abdomen)
•Prishtvedna (low back pain
•Yoni srava( vaginal discharge)
•Gramyadharmaruja ( Dyspareunia)
Objective criteria
•Cervical motion tenderness
•Adnexal/ Fornix tenderness
•USG finding ( fluid in pouch of Douglas)
Investigation-
•CBC
•ESR
•RBS
•LFT
•KFT
•Urine examination R/M
•USG pelvis (lower abdomen)/TVS
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1• Patient willing for trial.
- •2• Married women 3• lower abdomen pain 4• Low back pain.
- •5• Abnormal cervical or vaginal discharge 6• Dyspareunia.
排除标准
- •1• Pregnant women 2• Unmarried 3• PID associated with prolapsed uterus.
- •4• Endometriosis/ Chocolate cyst.
- •5• Severe or chronic ill health condition like diabetes mellitus & Hypertension tuberculosis etc.
结局指标
主要结局
subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness
时间窗: Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
2)To assess the efficacy of trial therapy on
时间窗: Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
1)To assess the efficacy of Brihatyadi Ghan vati and Laghu Panchmula kwath prakshalan
时间窗: Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
with taila pichu in management of Paripluta Yonivyapad
时间窗: Final assessment will be done after completion | of trial of 4 consecutive months (3 months with | clinical therapy and 1 month drug free)
次要结局
- To assess the efficacy of trial therapy on(subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness USG finding ( fluid in pouch of Douglas))