Clinical Evaluation of Vajraka Ghrita, Arogyavardhini Vati and Dineshavalyadi Taila in the Management of Kitibha (Psoriasis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- •Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of the disease by Reduction in Psoriasis Area and Severity Index (PASI) Score, PASI 50 (50% improvement in PASI score)
研究概览
简要总结
This study is aiming in generating the evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations a multi centric clinical trial has been initiated in psoriasis at 2 Institutes of Central Council for Research in Ayurvedic Sciences as an activity under Intra Mural Clinical Research Programme. Ayurvedic medicines Vajraka ghrita 6 gm twice daily, Arogyavardhini vati 250 mg twice daily and Dineshavalyadi taila 20 ml twice daily for external application will be given for 12 weeks in 120 patients of Psoriasis. This study will be conducted in 2 centres in India and completed in 3 years duration . The primary outcome measures will be relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of the disease by Reduction in Psoriasis Area and Severity Index (PASI) Score, PASI 50 (50% improvement in PASI score). Secondary outcomes will be Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of PASI 25. Improvement in Dermatology Life Quality Index (DLQI) Questionnaire.
Compostion of Drugs:
- Composition of Vajaraka Ghrita:
Vasa - Adhatoda Vasaka, Guduchi - Tinospora cordifolia
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
- •1.Known cases of psoriasis, without psoriatic arthropathy, Exhibiting psoriatic triad – I.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion II.Under the scales there appears a pinkish moist tender skin III.With the scarping of the moist skin there appear tiny blood droplets (Auspitz’s sign) 2.Patients suffering from mild to moderate psoriasis with less than 50 % of the body surface involvement 3.Patients having less than 10 years duration 4.Positive histopathological finding.(Skin-biopsy.
排除标准
- •1.Age below 18 years and above 60 years 2.Patients with other forms of Psoriasis like Guttate/ Pustular/ Erythrodermic/ inverse.
- •3.Patients suffering from severe psoriasis with more than 50% of the body surface involvement 4.Patients having chronic disease i.e. more than10 years duration 5.Patients who cannot report in person every 2 weeks in the OPD 6.Patients with Psoriatic arthropathy 7.Patients with poorly controlled Hypertension ( >160/100 mmHg) 8.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 7.5% 9.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
- •10.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •11.Symptomatic patient with clinical evidence of Heart failure.
- •12.Known HIV positive cases 13.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 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]), or any other condition that may jeopardize the study.
- •14.Alcoholics and/or drug abusers 15.H/o hypersensitivity to any of the trial drugs or their ingredients
- •Pregnant/lactating woman.
- •17.Patients who have completed participation in any other clinical trial during the past six months.
- •18.Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
•Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of the disease by Reduction in Psoriasis Area and Severity Index (PASI) Score, PASI 50 (50% improvement in PASI score)
时间窗: 12 Weeks
次要结局
- •Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of PASI 25.(•Improvement in Dermatology Life Quality Index (DLQI) Questionnaire.)