CTRI/2017/10/010105已完成3 期
A Prospective, Randomized Double Blind, Active Controlled, parallel Comparative Clinical Study to Evaluate the Efficacy and Safety of DEXAMETHASONE-AGIO (Dexamethasone sodium phosphate 4mg/ml) Injection of Agio Pharmaceuticals Ltd. Mumbai, India with DEXAMETHASONE (Dexamethasone sodium phosphate 4mg/ml) Injection of the company KRKA Slovenia in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract
Agio Pharmaceuticals Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
- •2. Patients with severe or incapacitating allergic conditions:
- •Bronchial asthma
- •Acute allergic bronchitis
- •Contact dermatitis
- •Atopic dermatitis
- •Seasonal or perennial allergic rhinitis
- •Drug hypersensitivity reactions
- •Urticarial transfusion reactions
- •Acute noninfectious laryngeal edema
排除标准
- •1. Patients who are not willing to give written informed consent
- •2. A medical history of significant hypersensitivity or allergic reaction to dexamethasone or any corticosteroids.
- •3. Current chronic use of steroids
- •4. patients with smoking habit
- •5. Patients being treated with antibiotics
- •6. Participation in any clinical trials prior to 12 months
- •7. Current treatment with immune-suppressants (eg, cyclosporine or methotrexate)
- •8. Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
- •9. Use of systemic corticosteroids in the visit to include Topical treatments at the site of lesions in the 15 days preceding the survey
- •10. Presence of secondary infections at the site of treatment, diagnosed clinically;
- •11.Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckleys syndrome
- •12. Pregnant or lactating women
- •13. Chronic alcoholism
- •14. Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patients participation in the study.
- •15. History of diabetic mellitus, thyroid dysfunction
- •16. Current or suspected diagnosis of viral, fungal, non infectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis,
- •17. History of muscle weakness
- •18. Severely immunocompromised patients
- •19. Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the products components, Cushingâ??s syndrome, gastric and duodenal ulcers, certain viral infections, i.e. varicella, herpes genita previous or current exposure to chicken pox, varicella virus and measles or have taken vaccination for the same.
- •20. Patients with positive serology laboratory values.
- •21. History of intubations for asthma or co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders)
研究者
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