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CTRI Number  CTRI/2015/01/005455 [Registered on: 23/01/2015] Trial Registered Prospectively
Last Modified On: 17/11/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of an Ayurvedic formulation for treatment of Chronic Cough.  
Scientific Title of Study   Clinical evaluation of Kushmandak Rasayana in the management of Chronic Bronchitis (Kaphaja kasa)  
Trial Acronym  CKMCB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prem Lal Bharati 
Designation  Research Officer Ay ( S- 2 ) 
Affiliation  National Research Institute for Ayurveda Siddha Human Resource Development 
Address  National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh Aamkho Gwalior.
National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prem Lal Bharati 
Designation  Research Officer Ay ( S- 2 ) 
Affiliation  National Research Institute for Ayurveda Siddha Human Resource Development 
Address  National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh Aamkho Gwalior.
National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prem Lal Bharati 
Designation  Research Officer Ay ( S- 2 ) 
Affiliation  National Research Institute for Ayurveda Siddha Human Resource Development 
Address  National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh Aamkho Gwalior.
National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Source of Monetary or Material Support  
Ayurveda Mental Health Research Institute, Nagpur, Maharashtra  
National Research Institute for Ayurveda Siddha Human Resource Development, Gwalior  
National Research Institute for Ayurvedic Drug Development, Kolkata  
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS  
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   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Kale  Ayurveda Mental Health Research Institute   Nandanwan Nagpur Maharastra
Nagpur
MAHARASHTRA 
9890746684
07122714203
kalekiran2004@yahoo.co.in 
Dr Ashok Kumar Panda  National Research Institute for Ayurveda Drug Development   Bidhan Nagar Kolkata West Bengal
Kolkata
WEST BENGAL 
9434631670
03323671001
akpanda_06@yahoo.co.in 
Dr Prem Lal Bharati  National Research Institute for Ayurveda Siddha Human Resource Development   Aamkho Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH 
9407587686
07512430317
plbharati@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethical Committee of Ayurveda Mental Health Research Institute, Nandanwan, Nagpur, Maharastra  Approved 
Institutional Ethical Committee of National Research Institute for Ayurveda Siddha Human Resource Development, Aamkho, Gwalior, Madhya Pradesh  Approved 
Institutional Ethical Committee of National Research Institute of Ayurvedic Drug Development, Bidhan nagar, Kolkata, West Bengal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kusmandak rasayana (API Part II, Volume I)  Dose -10 gm twice daily, Dosage form -Avaleha, Route of Administration - Oral, Time of Administration -Empty stomach, morning and evening, Anupana -Lukewarm Water, Packing form -300 gm each packing, Duration of therapy -12 weeks.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 To measure any clinical control by clinical COPD questionaire (CCQ)
2 Any acute exacerbations during the trial period.
 
one Year 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
one Year 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/02/2015 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 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.
 
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