CTRI/2023/06/053619尚未招募3 期
Treatment tolerability, medication adherence and safety of Ayurvedic formulations in the management of Psoriasis: An open label single arm study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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.Patients of any gender, in the age group 18 and 60 years.
- •2.Known cases of psoriasis, without psoriatic arthropathy, exhibiting psoriatic triad â??
- •a.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion.
- •b.Under the scales there appears a pinkish moist tender skin.
- •c.With the scraping of the moist skin there appear tiny blood droplets (Auspitzâ??s sign)
- •3.Patients suffering from psoriasis with less than 50 % of the body surface involvement.
- •4.Disease duration between 3 months to 5 years.
- •5.Willing to give informed consent.
排除标准
- •Patients with the following criteria will be excluded from the study:
- •1.Generalized skin lesions and a diagnosis for recent history of Herpes simplex, Herpes zoster, Scabies, Acne, Urticaria, and Immunological medicated skin diseases like Pemphigus vulgaris, Dermatitis,herpetiformis, Lupus erythematous, Psoriatic arthropathy etc.
- •2.Patients with poorly controlled Hypertension (Blood pressure more than 160/100mm of Hg).
- •3.Pregnant or lactating women.
- •4.Patient with uncontrolled Diabetes Mellitus (Hb A1C >8).
- •5.Patient who are known cases of autoimmune disorders.
- •6.Patient suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, cardiovascular disease Tuberculosis, Psycho - Neuro-endocrinal disorders, etc.).
- •7.Patients on medication with corticosteroids, phototherapy, biologics,antidepressants or any other drugs that may have an influence on the outcome of the study in the last 6 months.
- •8.Patients withHepatic Dysfunction (defined as AST and/or ALT >2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl)
- •9.Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or AIDS or STD or other concurrent severe disease.
- •10.Alcoholics and/or drug abusers, & smoking.
- •11.H/o hypersensitivity to the trial drug or any of its ingredients.
- •12.Patients who have completed participation in any other clinical trial during the past six months.
- •13.Any other condition, which the Investigator thinks, may jeopardize the study.
研究者
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