CLINICAL STUDY ‘KABHAPEENISAM’ (SINUSITIS)AND THE DRUG OF CHOICE IS SUKKATHI CHOORANAM(INTERNAL) and INJI THYLAM(EXTERNAL) .
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome is mainly assessed by laboratory and clinical symptom scoring.
研究概览
简要总结
It is a single, non-randomized, open-label trial to determine the efficacy and safety of SUKKATHI CHOORANAM in patients with KABHA PEENISAM (SINUSITIS).In this trial 40 sinusitis patients will be recruited and the trial drug will be administered 1.5 gm twice a day along with cow’s ghee for a period of 24 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age :18-50Yrs •Sex – Both male & female •The symptoms of pain in the face, purulent nasal discharge, and headache/heaviness of head, sneezing, fever, tooth ache, nasal block, and presence of any three symptoms will be taken as inclusion criteria.
- •â€¢Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 24 days but can opt out of the trial of his/her own conscious discretion.
- •â€¢Patients who are willing for radiological investigation (X-ray for Paranasal sinuses) and provide blood, urine for lab investigation.
排除标准
- •Bronchial asthma Tuberculosis Diabetes mellitus Hypertension Heart disease Chronic obstructive pulmonary disease.
结局指标
主要结局
The outcome is mainly assessed by laboratory and clinical symptom scoring.
时间窗: Pre study screening and after treatment
次要结局
- Clinical assessments(Pre study screening and after treatment)