An open clinical trial to evaluate the therapeutic efficacy of siddha herbo mineral formulation of "Ganthaka Rasaayanam"(Internal medicine) and "Vettiver Thylam"(External medicine) for the management of "Kalanjagapadai"(Psoriasis)
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
研究概览
简要总结
It is a single, non-randomized, open-label trial to determine the efficacy of GANTHAKA RASAAYANAM (Prepared from herbo mineral constitutents) in patients with
KALANJAGAPADAI (PSORIASIS). In this trial 40 patients will be recruited and the trial drug will
be administered 2 gm twice a day for a period of 40 days. During this trial period all the study
related data will be recorded and documented in a page 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. 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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Erythema 2.Thickness 3.Silvery scaling 4.Auspitz sign positive 5.Candle crease sign positive 6.Patients willing to give specimen of blood for investigation whenever required 7.Patients willing to take photograph 8.Patients willing to participate in the trial and signing consent by fullfilling the condition of proforma.
排除标准
- •1.Diabetes mellitus 2.Pregnancy and lactation 3.Psoriasis with evidence of any other skin disease or evidence of secondary infection in the lesion 4.Psoriatic arthropathy 5.Cardiac disease 6.Hansens disease 7.Any other chronic illness.
结局指标
主要结局
Good outcome –Clearance of lesions and
时间窗: 40 Days
Reduction of PASI Score from 3,4 to 0,1.
时间窗: 40 Days
Moderate outcome –Partial clearance of lesions
时间窗: 40 Days
and Reduction of PASI Score from 3,4 to 2.
时间窗: 40 Days
Mild- Slight clearancce of lesions and reduction of PASI score from 4 to 3
时间窗: 40 Days
Nil- NO Clearance of lesions or No reduction PASI Score
时间窗: 40 Days
次要结局
未报告次要终点