Clinical Evaluation of Mahatriphaladya Ghrita in the Management of Allergic Conjunctivitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
-  Symptomatic improvement.
研究概览
简要总结
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. This present clinical trial on Allergic Conjunctivitis is one of these eighteen clinical trials.
Mahatriphaladya Ghrita is a medicated semisolid poly-herbal formulation containing Haritaki (Terminalia chebula), Bibhitaki (Terminalia belerica), Amlaki (Emblica officinalis), Bhrngaraja (Eclipta alba), Vasa (Adhatoda vasica), Satavari (Asparagus racemosus), Guduci (Tinospora cordifolia), Pippali (Piper longum), Draksa (Vitis vinifera), Utpala (Nymphaea stellata), Madhuka (Glycyrrhiza glabra), Kantakari (Solanum xanthocarpum), Ksira kakoli (Fritillaria roylei), Aja kshira (goat milk) and Goghrta.
The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Mahatriphaladya Ghrita - a classical Ayurvedic formulation. This formulation has been in use since ages and found to be useful in treating Allergic Conjunctivitis and promoting the health.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.
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
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 16-35years.
- •Patients presenting with signs and symptoms of Allergic Conjunctivitis.
- •Willing and able to participate for 16 weeks.
排除标准
- •Patients having complications like marginal corneal ulcer, dacryocystitis, trachoma, kerato.
- •conjunctivitis, Infective conjunctivitis, etc.
- •Patients having genetic predisposition to allergy.
- •Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •Pregnant / lactating females
- •Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
- •Smokers/Alcoholics and/or drug abusers
- •Patients with evidence of malignancy
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
- •H/o hypersensitivity to the trial drug or any of its ingredients.
- •Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the P.I. thinks may jeopardize the study.
结局指标
主要结局
 Symptomatic improvement.
时间窗: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
次要结局
未报告次要终点