CTRI/2011/12/002204已完成2 期
Pharmaceutical Standardization of Vyaghrihareetaki Avaleha and Granules and their effect on Tamaka Shwasa (Bronchial Asthma)
Institute for Post Graduate Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年10月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Changes in the cardinal symptoms of Tamaka shwasa.
研究概览
简要总结
This study is an Open, Randomized, Controlled, Clinical study to evaluate the efficacy of Group A - Vyaghrihareetaki avaleha (jaggery based), Group B - Vyaghrihareetaki avaleha (sugar candy based), Group C - Vyaghrihareetaki granules (sugar candy based) in the management of Tamaka shwasa (Bronchial asthma). The primary outcome measures are Changes in signs and symptoms of Tamala shwasa, ACQ, ACT score, Respiratory rate, Breath holding time, PEFR changes before treatment and after 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having signs and symptoms of Tamaka Shwasa as described in Ayurvedic classics.
- •Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6 months.
- •Symptoms/exacerbation (Wheeze, cough and breathlessness) more than once a week but less than once a day in frequency.
排除标准
- •1.Age more than 60 years and below 16 years.
- •2.Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
- •3.Dyspnoea resulting from other diseases like left ventricular failure, COPD (Chronic Bronchitis, Emphysema), upper respiratory tract obstruction, bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational lung disease, tropical pulmonary eosinophilia & allergic bronchopulmonary aspergillosis etc.
- •4.Patients having anaemia, pneumonia, tuberculosis, lung cancer, lung abscess and other such complicated conditions.
- •conditions in which urination is markedly diminished or excessive were excluded.
- •6.HIV positive cases.
- •7.Pregnant/lactating mother.
- •8.Patients having classical symptoms of Maha, Urdha, Chinna and Kshudra Shwasa.
结局指标
主要结局
1.Changes in the cardinal symptoms of Tamaka shwasa.
时间窗: 0, 4 weeks
2. Changes in ACQ and ACT score and PEFR.
时间窗: 0, 4 weeks
次要结局
- Respiratory rate and Breath holding time(0, 4 weeks)
研究者
研究点 (1)
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