| CTRI Number |
CTRI/2025/01/078857 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
AYURVEDA |
| Study Design |
Other |
|
Public Title of Study
|
Understanding The Causes Of Different Types Of Kasa(COUGH) In Relation To Absolute Eosinophil Count. |
|
Scientific Title of Study
|
Observational Study Of Etiopathogenesis Of Various Types Of Kasa (Cough) In Comparison With Absolute Eosinophill Counnt |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajdatta Vijay Desai |
| Designation |
Associate Professor |
| Affiliation |
DR. D. Y. PATIL VIDHYAPEETH, PUNE (Deemed to be University) |
| Address |
Department Of Rognidan Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune
Pune
MAHARASHTRA
416018
India |
| Phone |
8390958851 |
| Fax |
|
| Email |
drrajdattadesai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash M Mane |
| Designation |
professor , Department of Rognidan |
| Affiliation |
Dr D Y Patil college of Ayurved and Research Centre pimpri pune |
| Address |
Department Of Rognidan Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune
Pune
MAHARASHTRA
416018
India |
| Phone |
9423277615 |
| Fax |
|
| Email |
prakash.mane@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash M Mane |
| Designation |
professor , Department of Rognidan |
| Affiliation |
Dr D Y Patil college of Ayurved and Research Centre pimpri pune |
| Address |
Department Of Rognidan Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune
MAHARASHTRA
416018
India |
| Phone |
9423277615 |
| Fax |
|
| Email |
prakash.mane@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune 411018
Tel 02027122125 |
|
|
Primary Sponsor
|
| Name |
Dr Rajdatta v Desai |
| Address |
Department Of Rognidan Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune 411018
Tel 02027122125 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajdatta Desai |
Dr D Y Patil college of Ayurved and Research Centre |
Dr D Y Patil college of Ayurved and Research Centre sant tukaram nagar pimpri pune 411018
Pune
MAHARASHTRA |
08390958851
drrajdattadesai@gmail.com |
| Dr Rajdatta Desai |
Hon Shri Annasaheb Dange Ayurved Medical College, Dhanvantari Hospital ,Ashta |
AP Ashta Tal walwa Dist sangli
Sangli
MAHARASHTRA |
8390958851
drrajdattadesai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. D Y Patil college of ayurved & research centre pimpri pune411018 Dr D Y Patil vidyapeeth pune(Deemed to be University) Approval Of Institutional Ethics commitee |
Approved |
| Hon.Shri. Annasaheb Dange ayurved medical college & ost graduate research center a/p ashta tal- walwa dist- sangli-416301, Institutinal ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J709||Respiratory conditions due to unspecified external agent. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male & female patients who are already dignosed for doshaj kasa are selected for study.
patients having age in between 18 yrs to 70 yrs are selected for study |
|
| ExclusionCriteria |
| Details |
Patients of systemic disorders like heart disease, tuberculosis,diabetismelitus, carcinoma are excluded from study |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To rule out that which type of kasa from ayurved litrature shows allergic presentation on the basis of result of absolute eosinophil count. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2)To correlate between diffrent type of kasa & result of absolute eosinophil count. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/02/2025 |
| 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
Modification(s)
|
Study is open label ,single arm, observatinal study. Study include 120 no of patints from india. INVESTIGATION done - Absolute eosinophil count. |