| CTRI Number |
CTRI/2020/02/023289 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study On Causes Of Cough With the Help Of Chest X-Ray |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON ETIOPATHOGENESIS OF KAPHAJA KASA AND ITS CLINICAL AND RADIOLOGICAL (CHEST X-RAY) DIAGNOSIS WITH SPECIAL REFERENCE TO CHRONIC BRONCHITIS AND EMPHYSEMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAVIKA CHAUDHARI |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA,
ROOM NO-301
PARUL INSTITUTE OF AYURVED,
PARUL UNIVERSITY,
P.O.-lIMDA, tA-WAGHODIA, DI-VADODARA STATE-GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
8758300137 |
| Fax |
|
| Email |
chaudharibhavika95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SACHIN DEVA |
| Designation |
READER |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA,
ROOM NO-301
PARUL INSTITUTE OF AYURVED,
PARUL UNIVERSITY,
P.O.-lIMDA, tA-WAGHODIA, DI-VADODARA STATE-GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9844810957 |
| Fax |
|
| Email |
dr.sachindev30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVIKA CHAUDHARI |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Ayurved |
| Address |
PG DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA,
ROOM NO-301
PARUL INSTITUTE OF AYURVED,
PARUL UNIVERSITY,
P.O.-lIMDA, tA-WAGHODIA, DI-VADODARA STATE-GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9844810957 |
| Fax |
|
| Email |
chaudharibhavika95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital,
Parul University,
Po. Limda, Waghodia, Dist Vadodara- 391760. |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department of Roga Nidana,
Parul Institute of Ayurved,
Parul University Campus, Po. Limda,Ta-Waghodia,
Dist-Vadodara- 391760 |
| Type of Sponsor |
Private 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 |
| DR BHAVIKA CHAUDHARI |
Parul Institute of Ayurved |
ROOM NO-106 KC OPD
ROOM NO-113 PK OPD
PARUL AYURVED HOSPITAL,
PARUL UNIVERSITY,
P.O.-lIMDA, tA-WAGHODIA, DI-VADODARA STATE-GUJARAT
Vadodara
GUJARAT |
8758300137
chaudharibhavika95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research (IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with lakshanas of Kaphaja Kasa
Patient presenting with features of Chronic Bronchitis |
|
| ExclusionCriteria |
| Details |
Vataja Pittaja Kshataja Kshyaj Kasa
Pregnancy
Bronchial Asthma Bronchiectasis Cardiac disorders and other major systemic disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Etiopathogenesis of Kaphaja Kasa and its Clinical and Radiological diagnosis |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Etiopathogenesis observed for Kaphaja Kasa |
1 day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
• Kaphaja kasa is one of the most common Pranavaha strotodushti vikara observed clinically. Increased Industrialization leading to pollution and other risk behaviours of individual is increasing day by day leading to increased prevalence of respiratory disorders especially Chronic bronchitis & Emphysema. Approximately 20% of males and 5% of females are affected from these set of disorders. WHO has defined pulmonary emphysema as combination of permenant dilatation of air spaces distal to the terminal bronchioles and the destruction of the walls of dilated air spaces. Thus, emphysema is usually diagnosed radiologically & morphologically, while chronic bronchitis is diagnosed clinically. But both the conditions coexists frequently and show considerable overlap in their clinical features. In this study an effort will be made to understand the etiopathogenesis of Kaphaja kasa and its clinical and radiological diagnosis with special reference to Chronic bronchitis and Emphysema which will help in better management and prevent further complications. |