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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other 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.
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