CTRI/2014/10/005143已完成未知
An Open Label, Prospective, Randomised, Two Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Stand Alone Therapy of Psorolin Oil in Comparison with the Additional Benefits of the Combined Therapy of 777 oil, Psorolin Bathing Bar, Psorolin Oil and Psorolin Ointment in Adult Subjects with Moderate to Severe Psoriasis.
Dr JRKs Siddha Research and Pharmaceuticals Private Limited0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and Female Adults between the ages of 18 and 50 years (both ages inclusive)
- •2.Psoriasis Body Surface Area at baseline is >3%
- •3.Subject w ho understand and willing to sign informed consent document before start of any study specific assessment.
- •4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- •5.Subject has not participated in a similar investigation in the past four weeks.
排除标准
- •1.Subjects with Psoriatic Arthritis.
- •2.Ongoing topical treatment or remedial measures for psoriasis inclusive of creams, lotions and oils 2 weeks before inclusion into the study.
- •3.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs or using corticosteroids and anti-inflammatory medicines until 15 days before inclusion into the study.
- •4.Subjects are using DMARDS or are on Psoralen+UVA - Phototherapy 4 weeks prior to inclusion into the study.
- •5.Subject with history of cancer including skin cancer.
- •6.Subject with serious dermatological infection in past three months requiring systemic therapy.
- •7.Subjects with facial melasma, lesions and other types of skin damage that is not psoriasis.
- •8.History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection.
- •9.History of opportunistic infections (e.g., systemic fungal infections, parasites)
- •10.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease or any other serious medical illness.
- •11.A known history or present condition of allergic response to any cosmetic products.
- •12.Females who are pregnant or lactating or planning to become pregnant during the study period.
- •13.Subjects who maybe allergic to any of the natural constituents of the Investigational Product.
- •14.Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrollment in the study.
研究者
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