Clinical evaluation of Kushmandak Rasayana in the management of Chronic Bronchitis (Kaphaja kasa)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 195
- 试验地点
- 3
- 主要终点
- 1 To measure any clinical control by clinical COPD questionaire (CCQ)
研究概览
简要总结
Kasa (Bronchitis) is prevalent all over the world and certainly most common acute
disease of lungs. It is characterized by inflammation of bronchial tubes and is much more
common in childhood and after middle age. Attacks are much more likely to occur in the winter
and spring seasons. Chronic bronchitis is a progressive, recurring inflammation of the lower
airways of the lungs called the bronchi and the bronchioles. The hallmark of chronic bronchitis is
a persistent wet cough and difficulty with breathing that slowly gets worse over time. Chronic
bronchitis is a kind of chronic obstructive pulmonary disease (COPD). Chronic bronchitis is a
seriously disabling disease with the potential for major complications. Chronic bronchitis is often
eventually fatal and is also a major cause of disability. Chronic bronchitis differs from acute
bronchitis in that acute bronchitis is caused by a viral infection or bacterial infection and is a
relatively short-term illness. Chronic bronchitis develops most often as a result of smoking, but
can also occur from long term inhalation of irritants into the lungs, such as air pollution,
chemical fumes, or dust. Chronic bronchitis can also develop due to long-term exposure to
second hand smoke. The longer the lungs are exposed to smoke, pollution or irritants, the higher
the risk for developing chronic bronchitis.
The symptoms of chronic bronchitis include shortness of breath, a loose cough that
produces large amount of mucus, and chest tightness. Complications of chronic bronchitis can be
serious, even life threatening, and result in additional symptoms. Diagnostic testing can include
lung function tests, such as a spirometry, which measures how much air is moved in and out of
the lungs. A chest X-ray and CT scan of the chest can evaluate such factors as the presence of
other conditions that may occur with or worsen chronic bronchitis, such
as pneumonia and congestive heart failure. There is no cure for chronic bronchitis. The goal of
treatment is to relieve symptoms and prevent complications. It is crucial to quit smoking to
prevent chronic bronchitis from getting worse. Any other respiratory irritants should be avoided.
Inhaled medications that dilate (widen) the airways and decrease inflammation may help reduce
symptoms such as wheezing. Antibiotics may be prescribed for infections as needed.
Corticosteroids may occasionally be used during flare-ups of wheezing or in people with severe
bronchitis that does not respond to other treatments. Physical exercise programs, breathing
exercises, and patient education programs are all part of the overall treatment plan. Oxygen
therapy may be needed in severe cases. In very severe cases, a lung transplant may be
recommended.
According to Ayurveda kasa is an independent disease, the Excellency of Ayurveda over
other medical sciences is that it had not only mentioned Kasa as a symptom in various disease
but also described it as an independent vyadhi (disease) with its separate Pathogenesis,
symptoms, signs, types and treatment. Ayurveda believes that Kapha Dosha dominating disease.
Those foods and other deeds that aggravate the Kapha Dosha also give rise to the cough.
Ayurveda describes five types of cough (kasa). This includes Vataja kaasa (produced by Vata
Dosha), Pittaja (by Pitta Dosha), Kaphaja (by Kapha Dosha), kshayaja and kshataja.
Characteristic features of Chronic Bronchitis are similar to Kaphaj Kas (Type of Kas) in the
Ayurvedic Science. The kaphaja kaasa is having white discharge and sweet taste all time in
mouth. The tongue is quoted and heaviness in the chest is felt. The person with this type of kaasa
may have headache. Patho-physiology, sign and symptoms and proper treatment of the disease is
very well described in all Ayurveda literatures. If control over kasa vyadhi is not achieved in
time it can give rise to life threatening diseases like Swasa, Shosa, Rajyakshama, Urakshata,
Rakttapitta, Granthi, Arbuda of respiratory tract etc.
There are number of drugs have been mentioned in the Ayurveda. Classical Ayurvedic
compound Kushmandak Rasayan is also described in the Bhaishajyaratnavali Raktapittadhikar
45, 47 for the successful treatment of Kaphaj Kas (Chronic bronchitis) since ancient times. In the
present study 65 patients will be studied in this IMR project. The observations and discussion
will be made according to statistical analysis on different standard parameters and clinical COPD
questionnaire (CCQ) score. The aim of this study is to evaluate of clinical efficacy of
Kushmandaka Rasayana in the management of chronic bronchitis (Kaphaj Kas).
Composition of Kusmandaka Rasayana (Bhaisajyaratnavali 45, 47)
1.Kusmanda, 2.Ghrita, 3.Khanda, 4.Pippali, 5.Sunthi, 6.Jirak, 7.Tvak, 8.Ela, 9.Patra, 10.Marica,
11.Dhanya and 12.Madhu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients of either sex aged between 18 to 70 years.
- •2 Patients with documented history of stable Chronic Bronchitis having persistent cough that produces sputum and mucus most of the days, for ≥ three months per year for ≥ 2 consecutive years.
- •3 Patients having FEV 1 between 50% -80% of predicted value.
- •4 Patient willing and able to participate in the study for 14 weeks.
排除标准
- •1 Presence of other pulmonary diseases or allergies like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Bronchial Asthma, Cystic fibrosis, Tuberculosis, Lung cancer, Pulmonary eosinophilia etc.
- •2 Patients having pulmonary infections other than Chronic Bronchitis.
- •3 Diabetes Mellitus 4 Patients on prolonged (over 6 weeks) medication with corticosteroids, bronchodilators, Mast cell stabilizers, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •5 Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho Neuro Endocrinal disorders, etc.) 6 Patients with past history of unstable cardiovascular diseases.
- •7 Patients with concurrent serious hepatic disorder defined as Aspartate AminoTransferase (AST) and or Alanine Amino Transferase (ALT), defined as over 2 times upper normal limit or Renal Disorders (defined as Serum Creatinine more then 1.2 mgdL).
- •8 Alcoholics and or drug abusers.
- •9.History of hypersensitivity to the trial drug or any of its ingredients.
- •10 Patients who have completed participation in any other clinical trial during the past six months.
- •11 Pregnant or lactating women.
- •12 Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
1 To measure any clinical control by clinical COPD questionaire (CCQ)
时间窗: one Year
2 Any acute exacerbations during the trial period.
时间窗: one Year
次要结局
- 1 Improvement functional exercise capacity by 6 minute walk test (6 MWT).(2 Safety of the drug by observing any adverse events ADR or lab parameters.)