CLINICAL EVALUATION OF KHADIRARISHTA, KAISHORE GUGGULU AND GANDHAKADI MALHAR IN THE MANAGEMENT OF VICHARCHIKA (ECZEMA)
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- To evaluate the clinical efficacy of Khadirarishta, Kaishoreguggulu and Gandhakadimalaharin Vicharchika (Eczema) by the assessmentof Change in Eczema Area Severity Index score (EASI)
研究概览
简要总结
Vicharchika is described under the KshudraKushthawhich is a chronic skin disorder*.* The general etiological factors areintake of incompatible foods/drinks, suppression of natural urges like vomitingetc., excess intake of fish, black gram, salty, sour and uncooked foods,Exposure to heat immediately after taking food, indulging in sexual activityeven if the food is not well digested, sleeping during day time etc. In thisstudy, Khadirarishta, Kaishore guggulu internally and Gandhakadi Malaharexternally are taken up for clinical evaluation and outcome will be measuredby assessment of Changein Eczema Area Severity Index score (EASI) and Changes in clinicalSign & symptoms as per the Ayurvedic classics, Changes in Patient Oriented Eczema Measure (POEM) and Changesin Dermatology Life Quality Index (DLQI) Questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Known cases of eczema (based on Hanifin and Rajka Criteria for Atopic Dermatitis/ Atopic Eczema) and willing and able to participate in the study.
排除标准
- •Patients with Status Eczematous condition.
- •Patients with poorly controlled Hypertension ( >160/100 mmHg) Patients with uncontrolled Diabetes Mellitus having HbA1C > 8% Patients on medication with corticosteroids, phototherapy, biologics, antidepressants and any other drugs that may have an influence on the outcome of the study.
- •Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months Symptomatic patients with clinical evidence of Heart failure Known cases of HIV and AIDS.
- •Known cases of malignancy Patient taking participation in any other clinical trial.
- •Women who are planning for conception / pregnant or lactating.
- •Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD) H/o hypersensitivity to any of the trial drugs or their ingredients Patients who have completed participation in any other clinical trial during the past three months Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
To evaluate the clinical efficacy of Khadirarishta, Kaishoreguggulu and Gandhakadimalaharin Vicharchika (Eczema) by the assessmentof Change in Eczema Area Severity Index score (EASI)
时间窗: 14th day 28th day 42th day 56th day 70th day 84th day
次要结局
- Changes in clinical Sign & symptoms as per the Ayurvedic classics(Changes in Patient Oriented Eczema measure (POEM)Changes in Dermatology Life Quality Index (DLQI) Questionnaire)