FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/08/004927 [Registered on: 26/08/2014] Trial Registered Retrospectively
Last Modified On: 19/01/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical study to evaluate the efficacy of Amrutadi vati and Vasadi vati in the treatment of Bronchial Asthma(Shwasa). 
Scientific Title of Study   A clinical study of Amrutadi vati and Vasadi vati in the management of Tamaka shwasa w.s.r. 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  Dr Parul R Kapadiya 
Designation  PhD scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda  
Address  Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9909919032  
Fax    
Email  drparulmd09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alankruta R Dave 
Designation  Associate professor incharge hod kayachikitsa 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda  
Address  Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9824171817  
Fax    
Email  alankruta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alankruta R Dave 
Designation  Associate professor incharge hod kayachikitsa 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda  
Address  Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9824171817  
Fax    
Email  alankruta@yahoo.com  
 
Source of Monetary or Material Support  
POST GRADUATE TEACHING HOSPITAL GAU JAMNAGAR 
 
Primary Sponsor  
Name  POST GRADUATE TEACHING HOSPITAL 
Address  GAU 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 
Dr Parul Rajnikant Kapadiya  OPD AND IPD kayachikitsa dept IPGTRA  dept of kayachikitsa IPGTRA GAU Jamnagar
Jamnagar
GUJARAT 
9909919032

drparulmd09@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  Bronchial Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amrutadi vati  orally 2tab.(500mg each) tds after food with luke warm water for 8weeks follow up 4weeks 
Comparator Agent  Vasadi vati  orally 2tab.(500mg each) tds after food with luke warm water for 8weeks follow up 4weeks 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either sex aged between 16 to 70 years
Patients having signs and symptoms of Tamak shwasa described in ayurvedic texts and modern texts will be included. 
 
ExclusionCriteria 
Details  Patients of age less than 16 and above 70 years
Patients with status asthmaticus asthma due to cardiac origin
Patients having complications like cor pulmonale emphysema pneumonia tuberculosis and malignancy etc and breathlessness due to
diabetes mellitus severe anaemia renal failure major endocrine disorders will be excluded from the study

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the clinical symptoms of Bronchial Asthma like
Dyspnoea
Wheezing
Coughing
Chest tightness etc 
8 weeks study and 4 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Spirometry  8 weeks study and 4 weeks follow up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   05/08/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1 PHARMACOGNOSTICAL AND PHARMACEUTICAL ANALYSIS OF AMRUTADI VATI IN THE MANAGEMENT OF TAMAKA SHWASA WSR TO BRONCHIAL ASTHMA Cite this Article as Kapadiya P R et al Pharmacie Globale IJCP 2014 03 01 2 PHARMACOGNOSTICAL AND PHARMACEUTICAL ANALYSIS OF VASADI VATI IN THE MANAGEMENT OF TAMAKA SHWASA WSR TO BRONCHIAL ASTHMA Cite this Article as Parul Rajnikant Kapadiya et al IJPRA Vol 4 Issue 5 2014 285 to 291 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Ayurveda refers to Bronchial Asthma as Tamaka shwasa. Asthma is a chronic inflammatory disorder of the airways. In which the chronic inflammation causes an associated increase in airway hyper responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night or in the early morning.

In modern medicine management of Asthma is done by Bronchodilators and corticosteroids controlling it but leading to dependency on allopathic drugs increasing its severity along with other side effects also.With the help of Ayueveda if we can control attacks of Shwasa and decrease dose of other medicine it will be very useful to society.

 According to Acharya Charaka the medicaments, foods and drink which control both Vayu and Kapha and having Ushna and Vatanulomana property should be given in Tamaka shwasa. Therefore Amrutadi vati was taken from Chakradatta Hikka Shwasa chikitsa prakranam which contains Guduchi, Nagarmotha, Bharangi, Kantakari, Tulsi, Pippali. This yoga has kapha, vatashamaka property by katu, tikta rasa and ushna virya. Vasadi vati was taken from Yogratnakar shwasa chikitsa adhyay, which contains Vasa, Haridra, Dhanyak, Guduchi, Bharangi, Pippali, Sunthi, Kantakari, Marich. This yoga has kaphashamaka property by katu tikta rasa and vatashamaka property by ushna virya.

Dose of both the drugs were 2tab. 500mg each tds after food with luke warm water for 8weeks and follow up was for 4weeks.

Total 75 patients were registered among them in Group A Amrutadi vati group total 41 patients were registered out of which 36 patients completed the treatment and 05 discontinued. In Group B Vasadi vati group total 34 patients were registered out of which 31 were completed the treatment and 03 discontinued.

Maximum 30.67% patients were belonged to the age group of 41 to 50 years, 61.33% were male, 38.67% were house wives, 13.33% were expose to dust, 48% were having constipation, 64% were having no addiction, 45.33% had past history of allergy, 68% were taking inhaler as modern medicine, 42.67% had positive family history of asthma.

In chief complaints Dyspnoea was found in 100% patients, Cold in 64% patients, productive coughing in 46.67% patients and dry coughing was found in 16% patients.

Maximum 60% patients were suffering from asthmatic attack on exertion and 52% during night time, 1to 5year chronicity was found in 38.67% patients. In relieving factors Orthopnoea was found in 81.33% patients.

 In Group A highly significant results were found in Dyspnoea, reducing the frequency of Dyspnoea, reduction of duration of Dyspnoea, decreasing the dose of emergency medicine used per week, Productive coughing and cold. In Group B highly significant results were found in Dyspnoea, reducing the frequency of Dyspnoea, reduction of duration of Dyspnoea, decreasing the dose of emergency medicine used per week, productive coughing and cold.

Group A showed significant improvement in S.Cholesterol and Total Protein. Group B showed significant improvement in FEV1%.

Group A provided marked improvement followed by moderate improvement in maximum patients while Group B provided moderate improvement followed by marked improvement in maximum patients.

It can be concluded from the study that this work can be helpful in management of Tamaka shwasa Bronchial asthma.

No any adverse effect was found in both the trial drugs but further Amrutadi vati proved as more effective in the patient of Bronchial Asthma in compare to Vasadi vati.

 
Close