A Randomized open labelled,parallel group study to evaluate the safety and efficacy of Cutisora oil and tablet in fixed dose as well as in combination therapy in patients with mild to moderate psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in the psoriasis area and severity index between baseline and end of study
研究概览
简要总结
Theclinical study entitled “A randomized open labelled, Parallel group study toevaluate the safety and efficacy of Cutisora Oil and Cutisora Tablet in fixeddose as well as in Combination therapy in patients with Mild to ModeratePsoriasis†is carried out in the skin care unit of R.G.G.P.G. Ayu. College & Hospital, Paprola, Distt.Kangra (H.P.). This trial is sponsored by Vasu Research Centre, Vadodara. Twodrug Cutisora oil and Cutisora capsule are clinically tested in the patients ofmild to moderate psoriasis with PASI score less than 20.
Total three group were made and 25patients were recruited in each group.
Group A - Cutisora oil group [Dose - topical Application twice a day]
Group B - Cutisora tablet group [Dose - 2 tablets twicea day]
Group C - Cutisora Oil and Cutisora tablet group [Dose- Topcial Application of oil and 2 tablets twice a day]
Mildto moderate relief is observed in all the three groups which is statisticallysignificant. Some of the patients in all the three group show no anyimprovement. The reason behind may be the dosage or the schedule of thetreatment as well as the other concomitant medication used by the patientpreviously. Psoriasis disability index has also been observed before and aftertrial but shows no any significant changes as we have recruited the patientsfor the trial of only mild to moderate psoriasis. The patients of group C haveshown comparatively better results hence both drugs are recommended to be usedin combined form.
Furtherit is suggested that Cutisora capsule should be used 2 tablets twice a dayalong with Cutisora oil locally twice a day for at least 6 months. So, that thedesired effect could be obtained. Therewas no any adverse drug reaction reported during the study and follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild to moderate psoriasis Psoriasis area and severity index of less than 20 Clinical chemistry and hematology results from visit 1 are within normal limits.
- •Non pregnant female and must agree to use adequate method of contraception during the study.
排除标准
- •Age less than 18 years and not more than 60 years Evidence of alcohol or drug abuse Evidence of unstable forms of psoriasis, including guttate, erthrodermic, exfoliative or pustular psoriasis.
- •Psoriasis area and severity index of more than 20 patients suffering from any critical disease of vital organs and chronic diseases like cancer, AIDS,TB etc.
结局指标
主要结局
Change in the psoriasis area and severity index between baseline and end of study
时间窗: Change in the psoriasis area and severity index between baseline and end of study
次要结局
- Psoriasis disability index (PDI) at base line and end of study(Time frame at 0 week, 6 week and 12 week)