FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086850 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Use of Vasa swaras bhavit vardhaman Pippali in patients of Tamak Shwas 
Scientific Title of Study   A clinical study of Tamak Shwas W.S.R to Bronchial Asthma, with trail drug Vasa Swaras Bhavit Vardhman Pippali a single group clinical trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Patil 
Designation  PG scholar kayachikitsa  
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD No. 4, Kayachikitsa Department, Government Akhandanand Ayurved College, Bhadra, Ahmedabad, Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9834646056  
Fax    
Email  mansipatil50094@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surendra A Soni 
Designation  HOD kayachikitsa department 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD No. 4, Kayachikitsa Department, Government Akhandanand Ayurved College, Bhadra, Ahmedabad, Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9408441150  
Fax    
Email  surendraasoni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surendra A Soni 
Designation  HOD kayachikitsa department 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD No. 4, Kayachikitsa Department, Government Akhandanand Ayurved College, Bhadra, Ahmedabad, Gujarat


GUJARAT
380001
India 
Phone  9408441150  
Fax    
Email  surendraasoni@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College and Hospital Ahmedabad 380001,Gujarat India 
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College 
Address  OPD No. 4, Kayachikitsa Department, Government Akhandanand Ayurved College, Bhadra, Ahmedabad 380001, Gujarat, 
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 
Mansi Patil  Government Akhandanand Ayurved College and Hospital  OPD No. 4, Kayachikitsa Department, Government Akhandanand Ayurved College, Bhadra, Ahmedabad 380001, Gujarat India
Ahmadabad
GUJARAT 
09834646056

mansipatil50094@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: VASA SWARAS BHAVIT VARDHAMAN PIPPALI, Reference: NA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 200(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: No, Additional Information: Dosage will be in vardhaman krama from 1 pippali to 10 pippali and from 10 pipalli to 1 pippali in decreasing order
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both male & female Patients having age greater than or equal to 18years and less than or equal to 60 years of age
Patient with chronicity of Tamaka Shwasa Less than 5 years.
Patients with classical signs and symptoms of Tamaka Shwasa described in ancient
Ayurveda text will be selected for present study such as
ShwasaKrichchhata (Dyspnoea)
Ghurghurukama (Wheezing sound)
Kasa (Cough)
Asamyakanidra (Disturbedsleep)
Kantodhwamsa (Hoarseness of voice)
Pinasa (Coryza)
ShleshmaVimokshanteMuhurtam Sukham (After expectoration patient feels
better).
ParshvaAvgrihyate (Chest tightness)
Aasinolabhatesaukhyama (Comfortable in sitting position)
Meghambusheetpragvataihi abhivardhate(increase symptoms after weather
change)
4.PEF greater than or equal to 50 % 
 
ExclusionCriteria 
Details 
Acute Dyspnoea, Relative Hypoxia And Cyanosis (Status Asthmaticus).
Patients suffering from any systemic or chronic illness like Emphysema,
Type 2diabetes mellitus, Hypertension, Renal diseases and Cardiac diseases.
Patients of Cor pulmonale, Pulmonary Hypertension, Cardiac Asthma and with severe
exacerbation.
Any acute systemic disease or Infection, post long covid lung disease/complication.
Pregnant and lactating mothers.
Any malignancy.
Acute & serious conditions require immediate intervention will be excluded.
PEF less than 50%
ILD (Interstitial Lung Disease)
Pulmonary Fibrosis and Consolidation
Chronicity More Than 5 Year  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Results will be assessed on the basis of
gradation of clinical features of Tamaka Shwasa 
7 days
14 days
21 days
30 days
40 days 
 
Secondary Outcome  
Outcome  TimePoints 
Peak flow meter reading to access improvement
of lung functions 
2 weeks of completion of clinical trial or
treatment
 
 
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 2/ Phase 3 
Date of First Enrollment (India)   25/05/2025 
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="8"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   According to Ayurveda Shwasaroga is a chronic disease of Pranavahastrotas. In Ayurveda “Prana” word refers to ‘Prana Vayu’(oxygen) or ‘Life’. Acharya Charak has described 5 types of Shwasa roga, Tamaka Shwasa is one of them. As per Acharya Charaka the roots of PranavahaSrotas are located in Hridaya & Mahasrotasa. Tamaka Shwasa is caused by vitiated Vata and Kapha mainly and designated as PittasthanaSamudhbhavaVydahi. The classical features of Tamaka Shwasa are Shwasakruchcchata, Ghurghurkama, Kasa, Asamyaka nidra, Asinolabhate saukhyama etc. Tamak Shwasa comprises mainly two Avasthas ,Vegkalin(Status Asthmaticus) and Vegottarkalin Avastha (Post Paroxysmal Condition). Both this Avashtha has different treatment modalities. In Vegkalin avastha ,Doshghna And Vatanulomak treatment is given while in Vegottarkalin Avastha, Deepan, Pachan, Shodhan/Strotoprasadan, Anuloman and Rasayan Chikitsa is taken into consideration.
Tamaka Shwas is Pittasthansamudbhav vyadhi. It is caused by vitiated Vata and Kaph dosha mainly. Due to vitiated doshas there is agni dushti , ama and strotoavrodhjanya symptoms. Ayurveda has complete approach to root eradication of disease i.e.moolvyadhi nirakaran through Apunarbhav Chikitsa.Therefore Ayurvedic management of Tamak Shwas is done in such a way that it works on root cause of the vyadhi i.e it improves status of agni ,reduces ama, treat strotoavrodh and provide strength not only to Pranavah strotas but whole body by Rasayan proparties.
As per ayurvedic classics,therapeutic principle of Vegottarkalin Shwas Roga,the food and drugs having kapha vatashamak, Vatanulomak, strotoshodhak properties are useful in treatment of Tamak Shwasa. Pippali Vardhaman Rasayan instructed in Rasayanv Pad 3 has been specially indicated for Shwas Kas Roga. Pippali has viDeepan ,Rasayan, Katu, Laghu, Vatshleshmahar And Strotoshodhak, Yogavahi properties. Its active ingredients like viiPiperine, Periongumine, Dihydro Stigmasterol promote respiratory health. So by this ingredient action, Pippali acts as decongestant, bronchodilator and expectorant. Vasa is also viiikaphanashak and swashar. It is an important drug acting on Pranavah Strotas, specifically as expectorant and bronchodialator. Its active ingredient Bromhexine has mucolytic property. So it is planned and assumed that Pippali if processed in Vasa Swaras , then the efficacy of Pippali Rasayan could be higher and the Ushna Tikshna Guna of Pippali could neutralized in Vasa processing ,as Vasa is Sheet Veerya drug.  
 
Close