Clinical Evaluation of Punarnavadi Madura and Dadimadi Ghrita in the Management of Iron Deficiency Anaemia
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
- Change in Hb%
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.xml:namespace prefix = o /
Punarnavadi Madura, is a classical polyherbal Ayurvedic formulation containing Punarnava (Boerhaavia diffusa), Trivrta (Ipomoea turpethum), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Vidanga (Embelia ribes), Devdaru (Cedrus deodara), Citraka (Plumbago zeylanica), Kustha (Saussurea lappa), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Haritaki (Terminalia chebula), Bibhitaka (Terminalia bellirica), Amlaki (Emblica officinalis), Danti (Baliospermum montanum), Cavya (Piper chaba), Indrayava (Holarrhena antidysenterica), Musta (Cyperus rotundus), Mandura Bhasma (Calcined Mandura), Gomutra (Cow urine).
Dadimadi Ghrita is a medicated ghrita containing Dadima (Punica granatum), Dhanyaka (Coriandrum sativum), Citraka (Plumbago zeylanica), Sunthi (Zingiber officinale), Pippali (Piper longum) and Ghrita.
Punarnavadi Madura and Dadimadi Ghrita have been in use since ages and found to be useful in treating Iron Deficiency Anaemia and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis.
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 protocol), 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
- 10.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex aged between 10 to 14 years
- •Children with iron deficiency anemia (Hb 8gm-10gm.%),
- •Willing and able to participate for 16 weeks.
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)
- •Co-morbidities like Tuberculosis, Chronic urinary tract infection, Bleeding disorders etc.
- •H/o hypersensitivity to any of the trial drugs 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
Change in Hb%
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 16 weeks.
次要结局
- 1.Symptomatic relief.(2. Change in Serum ferritin level.)