| CTRI Number |
CTRI/2025/11/096778 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Obstructive lung disease through signs, symptoms, X-ray and spirometry |
|
Scientific Title of Study
|
Clinico-radiological profiling of svasa vyadhi with special reference to obstructive lung disease: A cross-sectional exploratory study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saisha Tulaskar |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahapur belgavi |
| Address |
KAHERs Shri B M Kankanadi Ayurveda Mahavidhyalaya Shahapur Belgavi
Karnataka
590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7972501364 |
| Fax |
|
| Email |
saishatulaskar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemlata Shete |
| Designation |
Associate professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahapur belgavi |
| Address |
KAHERs Shri B M Kankanadi Ayurveda Mahavidhyalaya Shahapur Belgavi
Karnataka
590003
Belgaum
KARNATAKA
590003
India |
| Phone |
8217623771 |
| Fax |
|
| Email |
hemlata.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Saisha Tulaskar |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidhyalaya shahapur belgavi |
| Address |
KAHERs Shri B M Kankanadi Ayurveda Mahavidhyalaya Shahapur Belgavi
Karnataka
590003
Belgaum
KARNATAKA
590003
India |
| Phone |
7972501364 |
| Fax |
|
| Email |
saishatulaskar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saisha Tulaskar |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidhyalaya shahapur belgavi 590003 |
| Type of Sponsor |
Other [Self Dissertation] |
|
|
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 |
| DrSaisha Tulaskar |
KLEs BMK Ayurveda Hospital and BIMS |
Department of roganidana opd no.1 and
opd no 60 BIMS
Belgaum
KARNATAKA |
7972501364
saishatulaskar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Commitee for Research on Human Subjects KAHERs Shri B M Kankanwadi Ayurveda Mahavidhyalaya and KLE Ayurveda Hospital Shahapur Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J984||Other disorders of lung. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with clinical symptoms suggestive of obstructive lung disorders
|
|
| ExclusionCriteria |
| Details |
Patients with restrictive lung diseases
Patients with active pulmonary infections
Patients with cardiac conditions that can mimic respiratory symptoms congestive heart failure
Patients with recent major surgery or trauma affecting respiratory function
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop a clinical and radiological profile of Svasa Vyadhi which will aid in better diagnostic profile of Svasa |
day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop clinical & radiological profile of svasa vyadhi W.S.R. to obstructive lung diseases |
18 months |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="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
|
Obstructive lung disorders are a major public health issue and rank among the top causes of morbidity and mortality worldwide Chronic Obstructive Pulmonary Disease (COPD) alone is the third leading cause of death globally, accounting for 3.23 million deaths in 2019 It has been estimated that by 2030 COPD will be one of the top causes of death worldwide Studies show that rural populations and people exposed to biomass fuel and smoke have a significantly higher risk With the growing burden of air pollution and an aging population the prevalence is expected to increase steadily Rising Demand for Ayurveda in Respiratory CareThere is a growing global shift towards Ayurveda for managing chronic respiratory conditions During the COVID-19 pandemic the use of Ayurvedic remedies for respiratory support and immunity enhancement saw a significant surge highlighting the increasing trust in Ayurveda for managing respiratory diseases Limitations based on the literature search Xray assessment in Svasa Vyadhi is not much explored use of chest X-ray as a diagnostic imaging technique is not explored some studies use Xray to asses respiratory disease but they don’t explain or discuss the findings More over the existing literature exists mainly on Tamaka Svasa corresponding it to bronchial asthma but the other types of Svasa Vyadhi are not discussed Addressing this gap through Clinico-radiological profiling will improve diagnostic clarity by integrating the gap between Ayurveda Clinical observation and modern diagnostic imaging |