FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/12/010845 [Registered on: 12/12/2017] Trial Registered Retrospectively
Last Modified On: 08/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see effect of some herbal drugs in the management of bronchial asthma (Tamaka Shwasa). 
Scientific Title of Study   “Comparative Study of Efficacy of ‘Shunthyadi Churna’ and ‘Parnasapanchaka Kwatha’ in the Management of Tamaka Shwasa with special reference to Bronchial Asthma”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ram Kishor Joshi 
Designation  Professor & Head of Department 
Affiliation  National Institute of Ayurveda 
Address  P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road
Jorawar Singh gate, Madhav Vilas palace, Amer road
Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ram Kishor Joshi 
Designation  Professor & Head of Department 
Affiliation  National Institute of Ayurveda 
Address  P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road
Jorawar Singh gate, Madhav Vilas palace, Amer road
Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shagufta Malhotra 
Designation  M.D. Scholar 
Affiliation  National Institute of Ayurveda 
Address  P.G. Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road
Jorawar Singh gate, Madhav Vilas palace, Amer road
Jaipur
RAJASTHAN
302002
India 
Phone  9988646655  
Fax    
Email  shagufta.malhotra@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road jaipur, rajasthan, 302002 
 
Primary Sponsor  
Name  National Institute of Ayurved 
Address  National Institute of Ayurveda, Jorawar Singh gate, Madhav Vilas palace, Amer road, Jaipur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Ram Kishor Joshi  National Institute of Ayurveda  PG deptt of kayachikitsa, NIA, Jorawar Singh gate, Madhav Vilas palace, Amer road
Jaipur
RAJASTHAN 
9414322297

joshirk1964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, NIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Tamaka Shwasa (Bronchial asthma),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parnasapanchaka Kwatha   Parnasapanchaka Kwatha in dose of 40 ml with Prakshepa of Pippali Churna (2gm) before meals twice a day orally for 30 days. 
Comparator Agent  Shunthyadi Churna   Shunthyadi Churna in dose of 5gm with lukewarm water as Anupana before meals twice a day orally for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient willing to give informed consent to participate for 30 days.
2.Patients of either sex with age between 18 to 60 years.
3.Patient with stable Bronchial Asthma (Tamaka Shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to trial.
4.Patient presents with signs & symptoms of Tamaka Shwasa (Bronchial Asthma) as mentioned in Ayurvedic and modern texts.
5.Symptomatic patient with positive test of reversibility (If possible).
 
 
ExclusionCriteria 
Details  1.Patients with severe Bronchial Asthma.
2.Patients present with co-morbid disorders. (D.M., T.B., R.A., Carcinoma etc.).
3.Patients suffering from pulmonary diseases other than bronchial asthma like COPD, Pleural effusion, Pneumonia.
4.Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic > 100 mm of Hg)
5.Patients with concurrent serious Hepatic disorder or Renal Disorders, severe Pulmonary Dysfunction, or any other systemic/serious complications like Cerebrovascular / Cardiovascular disease that may jeopardize the study.
6.H/o hypersensitivity to the trial drug or any of its ingredients.
7.Patients who have completed participation in any other clinical trial during the past six months.
8.Pregnancy or lactating women.
9.Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients of either sex 18-60 yr old diagnosed with tamaka shwasa (Bronchial asthma) will be selected for relief in sign and symptoms  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assess comparative efficacy of shunthyadi churna and parnasapanchaka kwatha in tamaka shwasa (Bronchial asthma)  30 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   06/11/2017 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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  

Tamaka Shwasa is a type of  Shwasa Roga in which patients feel excessive difficulty in breathing and drowning in dark. It may be defined as a Kapha-Vataja disease of Pranavahashrotasa, originating from Pitta Sthana, in which there is derangement of Prana Vayu, along with obstruction by Kapha; the vitiated Vayu attains Pratilomgati and the respiration is disturbed with feeling of tightness of chest, choking of neck or feeling of merging in darkness. It is analogous to Bronchial Asthma due to similarity in symptoms, pathogenesis, onset, causes and precipitating factors. Bronchial Asthma is characterized by chronic airway inflammation and increased airway responsiveness resulting in symptoms of wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow limitations which usually reverse spontaneously or with treatment. Current estimate suggest that 300 million people worldwide suffer from Asthma and an additional 100 million may be diagnosed with Asthma by 2025. According to WHO, by the year 2020, Asthma along with COPD will become the third leading cause of death.  India has estimated 15-20 million asthmatics. The available treatment in modern medical science like Bronchodilators, Steroids even in the form of inhalers have made tremendous success in providing instant or symptomatic relief in Bronchial Asthma. But there is recurrent acute exacerbation with remissions and treatment has many side effects like nausea, vomiting, tremor and huskiness of voice. So, need of time is to go for herbal remedies and procedures which not only treat the above ailment but are cost effective, safe and reduces the episodes of relapse of the disease. Keeping this fact in mind, the clinical trial is proposed. A number of formulations have been mentioned in Ayurvedic classics for the treatment of Tamaka Shwasa. Vata and Kapha are the predominant Doshas involved in the pathogenesis of Tamaka Shwasa. The treatment must be of Vatahara and Kaphahara line along with the clearing of the passage of Pranavaha Srotas. Therefore, the drugs with the above said qualities are needed for relieving the symptoms of Tamaka ShwasaKeeping all above points in mind, the two compound drugs Shunthyadi Churna and Parnasapanchaka Kwatha have been selected to know their effect in treating Tamaka Shwasa (Bronchial Asthma). The drugs are to be administered orally, so does not require any specific instrument or training as in case of inhalers and nebulizers. The contents of the drugs are cheap and easily available so the treatment cost is minimal and can be afforded even by poor patients.

 
Close