Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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.
Brahmi Ghrita is a poly herbal formulation containing Brahmi (Bacopa monnieri), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Trivrta (Operculina turpethum), Danti (Baliospermum montanum), Shankhapushpi (Convolvulus pluricaulis), Aragvadha (Cassia fistula), Saptala (Euphorbia dracunculoides) and Vidanga (Embelia ribes).
Jyotismati Taila is oil obtained from a plant named Jyotishmati (Celastrus paniculatus).
The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Brahmi Ghrita and Jyotishmati Taila- classical Ayurvedic formulations which have been in use since ages and found effective in treating Cognitive Deficit 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
- 8.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex aged between 8 to 13 years
- •Children with Intelligence Quotient
- •84 (Weschler’s-IQ Indian adaptation by Malin)
- •Willing and able to participate for 16 weeks. (Assent to be obtained from Parent(s) / Guardian(s)).
排除标准
- •Children suffering from major systemic illness necessitating long term drug treatment.
- •Children with evidence of malignancy.
- •Children with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine > 1.2mg/dl) Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients)
- •H/o hypersensitivity to any of the trial drug or their ingredients
- •Children 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
- • Change in Modified Child Mini Mental Scale Examination (MMMSE).(At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.)