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
|
|
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
|
|
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). |