An Open Labelled Active Controlled Randomized Clinical Study to Evaluate the efficacy of Marichadi Gutika in Shwasa with special reference to Chronic Obstructive Pulmonary Disease (COPD)
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Principal Parul Institute of Ayurved
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To Evaluate the Effect of Marichadi gutika in Shwasa with special reference to COPD on basis of Spirometry of GOLD guidelines 2023 of COPD.
概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a heterogenous lung condition characterized by Chronic respiratory symptoms (dyspnea, cough, sputum production, and exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstructioncaused by exposure to noxious particles or gases, chemical irritants, smoking, tobacco and influenced by host factors including abnormal lung development. It alters the span and quality of life. Excluded from this definition is bronchial asthma, which also produces reversible chronic airflow obstruction. COPD is a group of progressive lung disease, most common are chronic bronchitis and emphysema. it is an inflammatory condition of respiratory system involving the airways, lung parenchyma, and pulmonary vasculature. The process is due to involve oxidative stress and protease-antiprotease imbalances. Chronic bronchitis is characterized by chronic cough with expectoration for at least 3 months of year for > 2 consecutive years. bronchitis causes inflammation and narrowing of bronchial tubes, which allows mucus to build up, cough with expectorated sputum and airflow limitation. Emphysema describes one of the structural changes seen in COPD where there is the slowly progressive destruction of the alveolar air sacs (gas-exchanging surfaces of the lungs) and loss of elastic recoil leading to obstructive physiology with or without fibrosis development. According to Ayurveda, respiratory diseases can be correlated with Pranavaha srotas vikara where cough, breathing difficulties, disturbed respiratory pattern, etc. are the main clinical features. Though it is impossible to correlate COPD with any single disease of Pranavaha sroto dushti, advanced conditions of diseases such as Kasa and Shwasa may result in conditions that resemble COPD. Shwasa roga is chiefly caused by vitiation of vata and kapha dosha but site of origin of this disease is pitta sthana. Vata dosha becomes vitiated in amashaya (pitta sthana samudbhava) due to specific causative factors (nidana). This vata dosha lead to dosha utklesh resulting in Jatharagni mandhya and ultimately there is formation of Ama. due to Jatharagni mandhya also affects Rasadhatu agni mandhya leading to formation of more Rasarupi mala (kapha). This vitiated vata dosha along with vikruta kapha causes the Pranavaha srotas obstruction which leasds to vilomagati of prana vayu contributing to manifestation of *shwasa roga.*Acharya sushruta explain prana vayu governs the process of breathing, nourishment and performs jatharagni deepana. In shwasa roga prana vayu is hampered by vikruta kapha dosha, it may be reasoning that patient of shwasa roga usually suffers from agni disorder. Many Ayurvedic drugs are effective in managing this disease and Marichadi gutika is one among them. Marichadi gutika is an efficient ayurvedic formulation that can maintain the balance of Vata and Kapha dosha in the body. It is very useful to get rid of respiratory conditions. It is an effective ayurvedic medicine that is helpful in bronchitis, having bronchodilatory effect, improve immunity and reduces inflammation in airway, reduces chest pain, helps in expectorating excess mucus. Ayurvedic research studies have proven that Sitopaladi churna is usefull in treatment of cough, various allergic conditions like bronchial asthma, chronic bronchitis, TB, COPD etc in all ages, stabilizing effects of Sitopaladi Churna on mast cell degranulation is proved. Anti-inflammatory effect, bronchodilation, reduces mucus production in the lungs and mitigates inflammation in the airways and lungs is also proved. This research proposal is aimed to evaluate whether Marichadi gutika will be effective in the management of Shwasa when compared to *Sitopaladi vati.*l Globally, COPD is major cause of chronic morbidity and mortality throughout the world. 90% of death occur in low- and middle- income countries (lmics). COPD was estimated to be the sixth leading cause of death in 2019. In India, COPD is the second most common lung disorder after pulmonary tuberculosis. Based on BOLD (Burden of obstructive lung disease) and large epidemiological studies, it is estimated that the Global prevalence of COPD is 10.3%. COPD among the population above 30 years in India between the years 2000 to 2020 prevalence of COPD is 7%. The prevalence of COPD is expected to rise over the next 40 years and by 2060 there may be over 5.4 million deaths annually from COPD and related conditions. The prevalence of COPD increased steeply with age, with the highest prevalence among those > 60 years. Prevalence of copd is appreciably higher in smokers and ex-smokers compared to non-smokers, in those> 40 years of age compared to those <40, and in men compared to women. bold reported an overall prevalence of copd of 11.8% for men and 8.5% for women. COPD can be estimated that globally there are around three million deaths annually due to COPD. is also a disease of increasing public health importance around the world. GOLD estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by 2023. The increasing prevalence of chronic obstructive pulmonary disease (COPD) has become an issue of serious public health concern. Globally, COPD is major cause of chronic morbidity and mortality throughout the world. 90% of death occur in low- and middle- income countries (lmics). COPD was estimated to be the sixth leading cause of death in 2019. In India, COPD is the second most common lung disorder after pulmonary tuberculosis. Based on BOLD (Burden of obstructive lung disease) and large epidemiological studies, it is estimated that the Global prevalence of COPD is 10.3%. COPD among the population above 30 years in India between the years 2000 to 2020 prevalence of COPD is 7%. The prevalence of COPD is expected to rise over the next 40 years and by 2060 there may be over 5.4 million deaths annually from COPD and related conditions. The prevalence of COPD increased steeply with age, with the highest prevalence among those > 60 years. Prevalence of copd is appreciably higher in smokers and ex-smokers compared to non-smokers, in those> 40 years of age compared to those <40, and in men compared to women. bold reported an overall prevalence of copd of 11.8% for men and 8.5% for women. COPD can be estimated that globally there are around three million deaths annually due to COPD. is also a disease of increasing public health importance around the world. GOLD estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by 2023. The increasing prevalence of chronic obstructive pulmonary disease (COPD) has become an issue of serious public health concern.
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
- 30.00 Year(s) 至 70.00 Year(s)(—)
入选标准
- •1.Age: From 30-year age to 70 years age (inclusive of either age) 2.Gender: Both.
- •3.Patients diagnosed with Mild to Moderate COPD as per GOLD Guidelines 2023 of Spirometry.
- •4.Patients willing and able to give written informed consent.
排除标准
- •1.Pregnant or lactating women.
- •2.Known case of Diabetes, uncontrolled hypertension, heart disease, secondary severe infections, Pleural effusion, pneumonia and pneumothorax, etc.
- •3.Severe and very severe cases of copd as per gold guidelines
- •4.History of upper or lower respiratory tract infection, within the previous 30 days.
- •5.History of lung resection of more than one full lobe.
- •6.Have a known sensitivity to formoterol, ipratropium, and salbutamol etc medicine.
- •7.Immunocompromised status such as HIV, tuberculosis, cancer, etc.
结局指标
主要结局
To Evaluate the Effect of Marichadi gutika in Shwasa with special reference to COPD on basis of Spirometry of GOLD guidelines 2023 of COPD.
时间窗: Baseline,Day 15,Day 30
次要结局
- Compare the efficacy of Marichadi gutika with Sitopaladi vati based on PEFR (through Peak flow meter), GOLD Guidelines 2023 of Spirometry for COPD.(Compare the efficacy of Marichadi gutika with Sitopaladi vati on Based on CAT SCORE and Modified MRC dyspnea scale.)
研究者
Dr Krupa Pravinbhai Patel
Parul Institute of Ayurveda