Efficacy of vyaghriharitaki avaleha with and without oriladi kashaya ghana vati in the management of tamaka shwasa (bronchial asthma) in children age 6 to 12 years a randomized controlled clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- 1.Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks.
研究概览
简要总结
TITLE OF THE STUDY
Efficacy of Vyaghriharitaki Avaleha with and without Oriladi Kashaya Ghana Vati in the management of Tamaka Shwasa bronchial asthma in children age 6 to 12 years a randomized controlled clinical study
RESEARCH QUESTION Does the add on administration of Oriladi Kashaya Ghana Vati along with Vyaghriharitaki Avaleha reduce the cardinal symptoms of Tamaka Shwasa Bronchial Asthma compared to oral administration of Vyaghriharitaki Avaleha alone in children aged 6 to 12 years over 45 days
HYPOTHESIS Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma is expected to effectively reduce asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone
NULL HYPOTHESIS H0 Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma has no significant reduction in asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone
ALTERNATE HYPOTHESIS H1 Administering Oriladi Kashaya Ghana Vati in combination with Vyaghriharitaki Avaleha orally twice daily after food dosed as per the patients age along with lukewarm water as Anupana for a period of 45 days to children aged 6 to 12 years diagnosed with Tamaka Shwasa Bronchial Asthma results in a significant reduction in asthma symptoms decrease their frequency duration and severity enhance pulmonary functions and ultimately enhance the quality of life in affected children compared to the oral administration of Vyaghriharitaki Avaleha alone
NEED OF THE STUDY
For healthcare providers the challenges of managing asthma differ between regions and health systems Despite lot of efforts to improve asthma care over the past 30 years and the availability of effective medications many patients globally have not benefited from advances in asthma treatment and often lack even the rudiments of care Many of the worlds population live in areas with inadequate medical facilities and financial resources GINA recognizes that the recommendations found in this report must be adapted to fit local practices and the availability of healthcare resources To improve asthma care and patient outcomes evidence based recommendations must also be disseminated and implemented nationally and locally and integrated into health systems and clinical practice Implementation requires an evidence based strategy involving professional groups and stakeholders and considering local cultural and socioeconomic conditions
This research aims to determine how well and how useful Oriladi Kashaya ghana vati along with Vyaghriharitaki Avaleha for treating Tamaka Shwasa in children Focusing on affordability and easy access the study seeks a practical way to manage childhood asthma and hopes to offer a safe and effective treatment that can be readily used in current healthcare
Considering the ongoing need for affordable and safe long term treatments for Tamaka Shwasa bronchial asthma even with the many formulations offered in Ayurveda the hence in this study a clinical trial is intended to evaluate the add on effect of Oriladi Kashaya ghana vati when administered along with Vyaghriharitaki Avaleha
AIM AND OBJECTIVE OF RESEARCH STUDY The aim of the present study is to assess the efficacy of interventions on the signs and symptoms of the disease Tamaka Shwasa vis a vis Bronchial Asthma and pulmonary function tests and quality of life parameters
OBJECTIVES OF THE RESEARCH PROJECT
PRIMARY OBJECTIVES To assess the efficacy of Oriladi Kashaya Ghana Vati as an add on to Vyaghriharitaki Avaleha in reducing cardinal signs and symptoms in terms of frequency severity and duration of Tamaka Shwasa in participants of the study
SECONDARY OBJECTIVES To assess improvement in the quality of life of the patients of Tamaka Shwasa by using the Paediatric Asthma Quality of Life Questionnaire PAQLQ To assess the reduction in FeNO level Pulmonary inflammation To assess improvement in Pulmonary Function Test by FOT Forced oscillation technique To assess and report any adverse drug reactions observed during and after the treatment period
OUTCOME MEASURES
PRIMARY OUTCOME 1 Improvement in classical signs and symptoms of Tamaka Shwasa in terms of reduction in frequency duration and severity of attacks
SECONDARY OUTCOME 1 Improvement in Paediatric Asthma Quality of Life Questionnaire PAQLQ 2 Reduction in FeNO level 3 Improvement in Pulmonary Function Test by FOT Forced Oscillation Technique 4 To assess any probable side effects such as gastrointestinal discomfort or pain altered taste dryness of mouth allergic reactions or any other side effects observed during and after the intervention period
PRIMARY ENDPOINT Change in total cardinal symptom score including frequency severity and duration of Tamaka Shwasa symptoms from baseline to the end of treatment period
SECONDARY ENDPOINT Change in total PAQLQ score from baseline to end of treatment period Change in fractional exhaled nitric oxide FeNO level measured in ppb from baseline to end of treatment Change in pulmonary function parameters measured by FOT from baseline to end of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children between 6–12 years of age irrespective of gender 2.Patients with mild to moderate bronchial asthma with at least three asthma episodes during last one year.
- •3.Diagnosis of asthma based on the criteria of the Global Initiative for Asthma (GINA).
- •4.Provided a signed statement of informed LAR consent/assent from both the parent/guardian and child/adolescent.
- •5.Patients with Tamaka Shwasa categorized under Sukha Sadhya and Krichra Sadhya as per Ayurvedic assessment will be included.
- •6.Patients on other drug therapy will be included only after completion of the wash out period prescribed.
排除标准
- •1.Patients below 6 years and above 12 years of age.
- •2.Patients with severe bronchial asthma with prolonged remissions (lasting more than a month).
- •3.Severe and Complicated respiratory allergic disorders those need hospitalization.
- •4.Diagnosed C/o Tuberculosis, Pleural effusion, Emphysema, Lung abscess, Bronchiectasis, Pleurisy, Nasal polyps, Congenital lung/cardiac anomalies, Chronic debilitating diseases 5.Individuals with significant cardiovascular conditions, additional infectious ailments, and clinically significant disorders affecting the cardiovascular, renal, hepatic, neurological, haematological, endocrine, or respiratory systems, are excluded.
- •6.Patients who are not willing to comply with the protocol requirements will be excluded from the study.
结局指标
主要结局
1.Improvement in classical sign and symptoms of Tamaka Shwasa in terms of reduction in frequency, duration and severity of attacks.
时间窗: 0th day, 15th day, 30th day, 45th day, 60th day, 75th day, 90th day
次要结局
- 1.Improvement in Paediatric Asthma Quality of Life Questionnaire (PAQLQ).(2.Reduction in FeNO level.)
研究者
Dr Swati Nair
ALL INDIA INSTITUTE OF AYURVEDA