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临床试验/CTRI/2024/07/071114
CTRI/2024/07/071114招募中2 期

Efficacy of Nidigdhikadi Kwatha alone & in combination with Ghritayavadi Dhuma in the management of Tamaka shwasa w. s.r to Grade -I COPD, A double arm open -label comparative study.

Ayurvedic And Unani Tibbia College And Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Improvement in subjective parameters like mMRC (Modified British Medical Research Council) Dyspnea scale , CAT (COPD assessment test) scale , GOLD criteria of spirometry , BODE index for Quality of life.

研究概览

简要总结

*INTRODUCTION:

Respiration is the most important feature of life which is carried out by Rana Vayu.iThere are various diseases like Hikka , Shwasa , Kasain which Prana Vayuget vitiated. Tamaka  Shwasais one among them.

In Ayurveda Tamaka Shwasais categorized under the five types of Shwasawhich affects *Prana Vaha Srotas.*Main causative factors responsible for Tamaka Shwasaare *Raja , Dhuma , Shitasthana- Shitambu Sevana etc ,*which leads to vitiation of Vatawith Kaphaleading to vitiation of function of Prana Vaha SrotasAcharya Charakahas mentioned that Tamaka Shwasais Kapha-Vataja Vikaraand site of its origin is Pitta Sthana. As per Acharya Charaka , Tamaka Showersis considered as Yapyavyadhi. However in individual with recent origin of disease and Pravara Balaperson , it is said to be Sadhya.

Chronic obstructive pulmonary disease on the basis of its etiological factors , signs and symptoms & pathophysiology can be correlated with advanced stage of Tamara Shwasa. Chronic Obstructive Pulmonary Disease (COPD) is a common , preventable & treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is not fully reversible .iiThe most common respiratory symptoms include dyspnea , cough and/or sputum production. COPD includes chronic bronchitis (cough & expectoration for 3 months in 2 consecutive years) , emphysema (abnormal permanent enlargement of airspaces distal to terminal bronchioles) and small airway disease (small bronchioles are narrowed and reduced in number).iii

*NEED AND SIGNIFICANCE:

Now a days majority of diseases affecting people are due to new age lifestyle , habits , occupational and environmental factors .Smoking and atmospheric pollution causes more incidence of disease .Today there is increased growth of industry which pollutes environment and also affects the people working in those industries and leads to various respiratory diseases and COPD is one among them. Recently cases of COPD are increasing day by day due to poor education of disease , low socio-economic status , lack of healthy lifestyle and poor hygiene , especially in India.

 In modern medicine for management of COPD , bronchodilators (oral/inhaler , long/short acting) , anti-inflammatory agents , antibiotics, antimuscarinic agents, mucolytic agents , methyl xanthines are commonly used and for severe conditions inhaled corticosteroids , oxygen therapy and surgery is also needed. But till date there is no any clinical evidence that any of these medications for COPD modify the long-term decline in lung function and quality of life and these are only effective in reducing symptoms , severity and frequency of exacerbations.

 Ayurveda has a significant role in management of diseases of Prana Vaha Srotas(COPD). In Ayurveda , line of treatment of every diseases is Nidana Parivarjanathat includes avoidance of causative factors of disease , modification of life style and diet. So , as per Ayurveda , treatment of COPD includes Nidana Parivarjana , Shodhana(purification of Doshas), Shamanaand *Rasayana Chikitsa ,*which can contribute effectively in management of COPD.

*DIAGNOSTIC CRITERIA:

Standard criteria for diagnosis of Chronic Obstructive Pulmonary Disease mentioned by Global initiative for Chronic Obstructive Lung Disease in Global strategy for the diagnosis , management , and prevention ofChronic Obstructive PulmonaryDisease (2021 Report )xxvwill be followed.

1.    The most common respiratory symptoms such as Chronic cough (May be intermittent and may be unproductive) , Chronic sputum production , and Exertional dyspnea ( Persistent , progressive over time , and worsen with exercise ) , wheezing and Chest tightness which may vary from day-to-day and precede the development of airflow limitation by many years.

2.    Variable expiratory air flow limitation done by Spirometry.

LABORATORY INVESTIGATION:

 1.CBC                                    -before & after treatment

2.ESR                                    -before & after treatment

3.AEC                                    -before & after treatment

4.LFT                                     -before & after treatment

5.KFT                                     -before & after treatment

6.HbA1C                                -before & after treatment

7.LIPID profile                        -before & after treatment

8.ECG                                    -before treatment.

9.Chest X - ray PA view         -before treatment

10.SPIROMETRY                  -every 30 days

11 .PULSE OXYMETRY        - every visit

  1. Urine Routine & microscopic - before treatment only to rule out any Urological & nephrological Pathology

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)(—)
性别
All

入选标准

  • 1 Symptomatological criteria.
  • patients having history of respiratory signs and symptoms mentioned in modern texts such as chronic cough, increased sputum production, exertional dyspnea, wheezing, chest tightness, Recurrent lower respiratory tract infections with a history of exposure to risk factors (Host factors– Genetic factors, Tobacco smoke, Occupation, Indoor or outdoor pollution) 2 Spirometry criteria–FEV1 divided by FVC less than 0.7and FEV1 greater than equals to 80 percent 3 Patients willing to participate in trial.

排除标准

  • 1 Pregnant and lactating women Patients having respiratory complications like Cor-pulmonale, and diseases like Active Pulmonary TB, Pneumonia, Status Asthmaticus, Cystic fibrosis, Pleural effusion, Pneumothorax, Lung cancer and other systemic diseases like Severe anaemia, Renal failure, Cardiovascular disease.
  • 2 Patients suffering from malignant and accelerated hypertension( 160 by 100 mm of Hg), coronary artery disease, uncontrolled diabetes(HbA1c greater than 8 percent).
  • 3 Patient undergoing regular treatment for any other severe illness and also patient on prolonged corticosteroid use.

结局指标

主要结局

Improvement in subjective parameters like mMRC (Modified British Medical Research Council) Dyspnea scale , CAT (COPD assessment test) scale , GOLD criteria of spirometry , BODE index for Quality of life.

时间窗: Day1,Day 91

次要结局

  • Overall improvement in quality of life.(Day1,Day 91)

研究者

发起方
Ayurvedic And Unani Tibbia College And Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Abinash Kar

Ayurvedic And Unani Tibbia College And Hospital

研究点 (1)

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