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CTRI Number  CTRI/2018/01/011549 [Registered on: 24/01/2018] Trial Registered Prospectively
Last Modified On: 07/06/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To observe the effect of Ayurvedic Medicine for the treatment of Chronic Cough 
Scientific Title of Study   Clinical Efficacy of Talisadi Churna in the Management of Kasa (Stable Chronic Bronchitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1208-0446  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Rinku Tomar 
Designation  Research Officer (Ay) 
Affiliation  Central Ayurveda Research Institute for Respiratory Disorders 
Address  Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001

Patiala
PUNJAB
147001
India 
Phone  9888685874  
Fax  0175-2223663  
Email  drrinkutomer2008@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Rinku Tomar 
Designation  Research Officer (Ay), Scientist-2 
Affiliation  Central Ayurveda Research Institute for Respiratory Disorders 
Address  Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001

Patiala
PUNJAB
147001
India 
Phone  9888685874  
Fax  0175-2223663  
Email  drrinkutomer2008@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Rinku Tomar 
Designation  Research Officer (Ay), Scientist-2 
Affiliation  Central Ayurveda Research Institute for Respiratory Disorders 
Address  Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001

Patiala
PUNJAB
147001
India 
Phone  9888685874  
Fax  0175-2223663  
Email  drrinkutomer2008@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi-110058  
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61 65 Institutional Area Opposite D Block Janakpuri New Delhi 110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rinku Tomar  Central Ayurveda Research Institute for Respiratory Disorders   Room No. 211, Clinical and Research
Patiala
PUNJAB 
9888685874
0175-2223663
drrinkutomer2008@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Central Ayurveda Research Institute for Respiratory Disorders Moti Bagh Road Patiala Punjab 147001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Kasa (Stable Chronic Bronchitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Talisadi Churna   Reference AFI I 7:13 API II Vol I Dosage 3 gm TDS with honey after food  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Change in Leicester Cough Questionnaire (LCQ) Scores.
2 Number of patients who did not have any episode of acute exacerbation from baseline to end point.

 
At baseline
During Treatment (After Every 14 days)
At the end of treatment
After follow up of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1 Quality of life outcome from St. George’s Respiratory Questionnaire (SGRQ) Score.
2 Functional Exercise capacity
3 Any adverse Events
 
At baseline
During Treatment (After Every 14 days)
At the end of treatment
After follow up of 4 weeks 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Kasa (Bronchitis) is prevalent all over the world and certainly most common respiratory ailment. 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 productive cough and difficulty with breathing that slowly gets worse over time. Chronic bronchitis is a kind of chronic obstructive pulmonary disease (COPD). 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 and even life threatening. There is no cure for chronic bronchitis. The goal of treatment is to relieve symptoms and prevent complications. Ayurveda had not only mentioned Kasa as a symptom in various diseases but also described it as an independent Vyadhi (disease) with its separate pathogenesis, symptoms, signs, types and treatment. Ayurveda believes that it is a Kapha Dosha dominating disease. Ayurveda describes five types of cough (Kasa). Characteristic features of chronic bronchitis are similar to Kaphaja Kasa (type of Kasa) in the Ayurvedic science. Ayurvedic compound formulation, Talisadi churna is described in the Sharngadhara Samhita, Madhyama Khanda, Adhyaya 6/130-133½ for the successful treatment of Kasa (Chronic bronchitis) since ancient times. In the present study 75 patients of Kasa (Chronic bronchitis) will be studied. The aim of this study is to assess the clinical efficacy of Talisadi Churna in the management of Kasa (Stable Chronic Bronchitis).The observations and discussion will be made according to statistical analysis on different clinical parameters esp. pulmonary function test and scores of questionnaires (St. George’s Respiratory Questionnaire & Leicester Cough Questionnaire). 

 
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