SAFETY AND COMPARATIVE OPEN CLINICAL STUDY OF “GANTHI MEZHUGU†(INTERNAL) AND “KUTTA NOIKALUKKU MEL POOTCHU ENNAI†(EXTERNAL) IN THE TREATMENT OF “KAALAANJAGAPPADAI†(PSORIASIS) WITH AND WITHOUT YOGAM THERAPY
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Good outcome –Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.
研究概览
简要总结
Itis a single, non-randomized, open-label trial to determine the efficacyand safety of GANTHI MEZHUGU (Prepared from herbo mineral constitutents)in patients with KAALAANJAGAPPADAI (PSORIASIS). In this trial40 patients will be recruited and the trial drug will be administered 260mg twice a day for a period of 48 days. During this trial period all thestudy related data will be recorded and documented in a page separatetrial master file for each patients.During the trial period if anyAE/SAE/SUSAR will be noticed and referred to pharmacovigilancedept.in NIS and further management will alsobe given in NIS OPD/IPD.The entire trial will be monitored by theresearch monitoring committee OF NIS. During this trial all the safety andefficacy parameters will be recorded in the CRF. After completion of thetrial all the study related data will be analysed statistically .The outcome 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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Erythema •Thickness •Scaling •Ithching :with or without itching •Auspitz sign + •Candle crease sign + •Age : 20-60 years •Sex : Both male and female •Willing to give specimen of blood for the investigation whenever required.
- •â€¢Willing to participate in trial and signing consent by fulfiling the condition of proforma.
排除标准
- •â€¢Hypertension •Diabetes Mellitus •Narcotic addicts •Pregnancy and lactation •Psoriasis with evidence of any other skin disease •Psoriatic arthropathy •Cardiac disease •Leprosy •Evidences of secondary infection in the lesions.
结局指标
主要结局
Good outcome –Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.
时间窗: PRE STUDY SCREENING AND AFTER | TREATMENT
Moderate outcome –Partial clearance of lesions and Reduction of PASI Score from 3,4 to 1,2.
时间窗: PRE STUDY SCREENING AND AFTER | TREATMENT
Poor/Nil- NO Clearance of lesions or No reduction PASI Score
时间窗: PRE STUDY SCREENING AND AFTER | TREATMENT
次要结局
未报告次要终点