| CTRI Number |
CTRI/2025/03/082962 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptomatic Management of Tamaka Swasa[Bronchial Asthma] Through Ayurveda |
|
Scientific Title of Study
|
An Exploratory Study to Evaluate The efficacy of Vyaghrijeerakavaleha in The Symptomatic Management of Tamaka Swasa[Bronchial Asthma] |
| Trial Acronym |
Interventional Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Kiran kumari |
| Designation |
PG SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurveda,jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurveda DR.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN India PIN-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
6350320655 |
| Fax |
|
| Email |
kirangurjar1306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Post Graduate Institute of Ayurveda,jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurveda DR.Sarvapalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN India PIN-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Post Graduate Institute of Ayurveda,jodhpur |
| Address |
P.G. Department of Kayachikitsa Post Graduate Institute of Ayurveda DR.Sarvapalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN India PIN-342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda jodhpur 342037 Rajasthan india |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda jodhpur |
| Address |
P.G.Department of Kayachikitsa,Post Graduate Institute of Ayurveda,DR.Sarvapalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN India PIN-342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR Kiran kumari |
Post Graduate Institute of Ayurveda Jodhpur |
P.G.Department of Kayachikitsa,Post Graduate Institute of Ayurveda,DR.Sarvapalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN India PIN-342037
Jodhpur
RAJASTHAN |
6350320655
kirangurjar1306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUONAL ETHICS COMMITTEE POST GRADUATE INSTITUTE OF AYURVEDA JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyaghrijeerakavaleha, Reference: Varihtta nighantu ratnakar shwas/rogahikar prakranaa, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity-above 18 years.patient willing to sign the consent form.
The patients between the age group of 18 to 70 years of either sex presenting with clinical feature of Tamak Swasa like,breathlessness,wheeze,paroxysm of attack,cough etc.irrespective of sex and religion |
|
| ExclusionCriteria |
| Details |
Age below and above 70 years.patients having Asthma due to secondary cause such as drug induced like aspirin.pregnant women and lactating mothers.Patient having concomitant systemic illness like uncontrolled hypertension,poorly controlled diabetes mellitus,renal failure,malignancy,acute or chronic liver disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assessment of subjective and objective parameters before and after treatment |
from base line 15th day,30th day,45th day,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any side effects if occur during clinical trial |
from base line 15th day,30th day,45th day,60th day |
|
|
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)
|
25/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
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
|
INTRODUCTION - Changing pattern of life styles, living standards, demographic factors, urbanization, over growth of industrialization & auto mobilization has led to increase in dust, allergens, pollutant toxic gases, vehicle smoke, cigarette smoking and stress which are responsible for the diseases of Pranavaha Srotasa like Pratishyaya, Shwasa, Kasa" and thus, remarkable increase in patient’s number suffering from these diseases now a days. Tamaka Shwasa or bronchial asthma is one such important disease of Pranavahasrotasa. Though ancient, Ayurveda is still contemporary and potential enough to deal the diseases of present era. It has its own modes of handling a pathological condition where by the consequences are absolutely desirable. In Ayurvedic context, difficulty in breathing or shortness of breath may be simply termed as Swasa Roga. It may be primary - originating from the respiratory system, secondary - originating from other systems of the body but the impact is on the respiratory system. Swasa Roga is mainly caused by the Vata and Kapha Doshas. |