A Comparative Pilot study on Peenisa thiri (Medicated fumigation Wick) with and without internal medicine of Gowri chinthamani chendhuram in the treatment of Kaba peenisam(Sinusitis)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the therapeutic efficacy of "Peenisa thiri" (Medicated fumigation wick) with and without "Gowri chinthamani chenthooram" (Internal) for the changes in the lab parameters in "Kabha peenisam" (Sinusitis)
研究概览
简要总结
It is a single non randomized open lable trial to determine the efficacy and safety of peenisa thiri (external medicine) with and without gowri chinthamani chenthooram (internal medicine )in patients with kabha peenisam (sinusitis).in this trial 20 patients will be recruited. the trial drug gowri chinthamani chenthooram 200mg twice a dayand peenisa thiri will be administered for 10 patients and the external medicine peenisa thiri will be administered for 10 patients for a period of 24 days.during the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance dept of NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitor by the research monitoring commitee of NIS.During this trial all the safety and efficacy parameter will be recorded in CRF.After completion of the trial all this study related data will be analysed statistically.The outcome of this trial will be puplished in indian journal of medical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who having the symptoms of pain in the face , purulent nasal discharge , head ache or heaviness of head , sneezing , fever , tooth ache , nasal block and presence of any three symptoms.
- •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 3) Patients who are willing for radiological investigations (Xray for Paranasal sinuses) and provide blood , urine for lab investigations.
排除标准
- •H/O Bronchial asthma 2)H/O Tuberculosis 3)H/O Diabetes mellitus 4)H/O Hypertension 5)H/O Heart disease 6)H/O Chronic obstructive pulmonary disease 7)H/O Thyroidism 8)H/O Renal disease.
结局指标
主要结局
To compare the therapeutic efficacy of "Peenisa thiri" (Medicated fumigation wick) with and without "Gowri chinthamani chenthooram" (Internal) for the changes in the lab parameters in "Kabha peenisam" (Sinusitis)
时间窗: To compare the therapeutic efficacy of "Peenisa thiri" (Medicated fumigation wick) with and without "Gowri chinthamani chenthooram" (Internal) for the changes in the lab parameters in "Kabha peenisam" (Sinusitis) for a period of 24 days
次要结局
- 1)To study the reduction in clinical symptoms and changes in lesion in radiological investigation(2)To study the siddha principles such as 3 humours, Naadi, 8 diagnostic method, Neerkuri, Nei kuri, 7 body constituents etc..)