Clinical Efficacy of Talisadi Churna in the Management of Kasa (Stable Chronic Bronchitis)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 1 Change in Leicester Cough Questionnaire (LCQ) Scores.
Study Overview
Brief Summary
Kasa (Bronchitis) is prevalent all over the world andcertainly most common respiratory ailment. Chronic bronchitis is a progressive,recurring inflammation of the lower airways of the lungs called the bronchi andthe bronchioles. The hallmark of chronic bronchitis is a persistent productivecough and difficulty with breathing that slowly gets worse over time. Chronicbronchitis is a kind of chronic obstructive pulmonary disease (COPD). Thesymptoms of chronic bronchitis include shortness of breath, a loose cough thatproduces large amount of mucus, and chest tightness. Complications of chronicbronchitis can be serious and even life threatening. There is no cure forchronic bronchitis. The goal of treatment is to relieve symptoms and preventcomplications. Ayurveda had not only mentioned Kasa as a symptom invarious diseases but also described it as an independent Vyadhi (disease)with its separate pathogenesis, symptoms, signs, types and treatment. Ayurvedabelieves that it is a Kapha Dosha dominating disease. Ayurveda describesfive types of cough (Kasa). Characteristic features of chronicbronchitis are similar to Kaphaja Kasa (type of Kasa) in theAyurvedic science. Ayurvedic compound formulation, Talisadi churnais described in theSharngadhara Samhita, Madhyama Khanda, Adhyaya 6/130-133½ for thesuccessful treatment of Kasa (Chronic bronchitis) since ancient times.In the present study 75 patients of Kasa (Chronic bronchitis) will bestudied. The aim of this study is to assess the clinical efficacy of Talisadi Churna in themanagement of Kasa (Stable Chronic Bronchitis).The observationsand discussion will be made according to statistical analysis on differentclinical parameters esp. pulmonary function test and scores of questionnaires(St. George’s Respiratory Questionnaire & Leicester Cough Questionnaire).
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 16.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Patients of chronic stable bronchitis suffering from minimum of two years.(Chronic bronchitis is defined clinically as chronic Productive cough for 3 months in each of 2 successive years in that patient in whom other causes of productive cough have been excluded) 2 Stable symptoms for the past 2 weeks i.e. unchanged amount & colour of daily sputum 3 FEV1 > 80% 4 Patient willing and able to participate in the study for 16 weeks.
Exclusion Criteria
- •1.Any other pulmonary diagnosis like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.
- •2.Patients of Diabetes Mellitus 3.Patients with poorly controlled Hypertension (equal or more than 160 / 100 mmHg).
- •4.Patients on prolonged (> 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 who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •7.Symptomatic patients with clinical evidence of Heart failure.
- •8.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL).
- •9.Smokers/alcoholics and/or drug abusers.
- •10.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •11.Any other condition which the Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
1 Change in Leicester Cough Questionnaire (LCQ) Scores.
Time Frame: At baseline | During Treatment (After Every 14 days) | At the end of treatment | After follow up of 4 weeks
2 Number of patients who did not have any episode of acute exacerbation from baseline to end point.
Time Frame: At baseline | During Treatment (After Every 14 days) | At the end of treatment | After follow up of 4 weeks
Secondary Outcomes
- 1 Quality of life outcome from St. George’s Respiratory Questionnaire (SGRQ) Score.(2 Functional Exercise capacity)