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CTRI Number  CTRI/2017/03/008038 [Registered on: 08/03/2017] Trial Registered Prospectively
Last Modified On: 07/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Shwasa Roga with Ayurveda 
Scientific Title of Study   A comparitive clinical study to evaluate the effect of Virechana Vamana & Shwasahara Yoga in the management of Tamaka Shwasa wsr Bronchial Asthma 
Trial Acronym  VViSY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Laveena Kumari 
Designation  MD 2nd Year 
Affiliation  Institute for Post Graduate Training And Research Centre 
Address  4th floor Department of Panchkarma IPGT and RA GAU Jamnagar
Room no 102 PGLH IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9416808122  
Fax    
Email  drlaveena2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anup Thakar 
Designation  Head Department Of Panchkarma IPGT and RA 
Affiliation  Institute for Post Graduate Training And Research Centre 
Address  IPGT and RA GAU Jamnagar
4th floor Department of Panchkarma IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Anup Thakar 
Designation  Head Department Of Panchkarma IPGT and RA 
Affiliation  Institute for Post Graduate Training And Research Centre 
Address  IPGT and RA GAU Jamnagar
4th floor Department of Panchkarma IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute For Post Graduate Training And Research In Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 
 
Primary Sponsor  
Name  Institute for Post Graduate Training And Research Centre 
Address  Gujarat Ayurved University Jamnagar 
Type of Sponsor  Research institution and hospital 
 
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 
Laveena Kumari  PG Hospital   OPD No 22 PG Hospital IPGT and RA Jamnagar
Jamnagar
GUJARAT 		 9416808122

drlaveena2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient diagnosed with Tamaka Shwasa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vamana with Madanphaladi Yoga and Shwasahara Yoga  In Group B Patient will undergo Deepana Pachana with Haritaki and Shunthi churna 2-3 gms TDS for 3-7 days followed by Snehapana with Goghrita then Abhyanga with Tila Taila and Vashpa Sweda for 1 day then Vamana with Madanphaladi Yoga followed by Shwasahara Yoga For 30 days and in Group C patients will be treated with Shwasahara Yoga only for 30 days 
Comparator Agent  Virechana wiyh Trivrut Avleha followed by Shwasahara Yoga for 30 days  In Group A patients will undergo Deepana Pachana with Haritaki and Shunthi Churna 2-3 gms TDS for 3-7 days then Snehapana with Goghrita then Abhyanga with Tila Taila and Vashpa Sweda for 3days then Virechana with Trivrut Avleha followed by Shwasahara Yoga for 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having classical features of Tamaka Shwasa (Bronchial Asthma)
1. Age- 18 to 60 years.
2. Chronicity- less than 10 years.
3. Patients with stable condition.
 
 
ExclusionCriteria 
Details  1. Age - <18 years, >60 years
2. Patients suffering from
a. Pulmonary tuberculosis
b. Lung Cancer, Lung fibrosis
c. Emphysema, Bronchiectasis
d. Cor- Pulmonale, IHD, Hypertension will be excluded.
e. Status asthematicus.
3.Type – 2 Diabetes with uncontrolled blood sugar levels.
4. Patients on Corticosteroids
5. Vamana Ayogya
6. Virechana Ayogya
7. Chronicity>10yrs
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms of Tamaka Shwasa  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Improves quality of life of the person  2 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   24/03/2017 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study comprises a Comparitive Clinical Study to evaluate the effect of  Virechana (Purgation), Vamana (Emesis) and Shwasahara Yoga( a combination of many herbal drugs) in the management of Tamaka Shwasa wsr Bronchial Asthma. As Tamaka Shwasa (Bronchial Asthma) has been mentioned as Pittasmudbhava Vyadhi( a disease arise from pitta dosha) so Virechana (Purgation) has been planned to pacify the pitta dosha. Besides this Tamaka Shwasa (Bronchial Asthma) is also having the Vata Kapha dominancy and Vamana (Emesis) is best treatment modelity in Kapha pradhana vyadhi hence Vamana (Emesis) has been planned in another group to treat the patients of Tamaka Shwasa (Bronchial Asthma)  .In both the groups after Shodhana (detoxification) procedure Shwasahara Yoga has been considered as internal medication to pecify remaining doshas. 
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