| CTRI Number |
CTRI/2019/04/018368 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
20/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Scale for assessing treatment outcome in vataja pratisyaya (Allergic Rhinitis) |
|
Scientific Title of Study
|
Development and validation of scale for assessing treatment outcome in vataja pratisyaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalakota Sahithi |
| Designation |
Post Graduate Scholar, Department of Samhita and Siddhanta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital , Hassan , Karnataka |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital, Department of Samhita and Siddhanta, third floor, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
8985714974 |
| Fax |
|
| Email |
sahithi4949@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja Suhas Hiwale |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital , Hassan , Karnataka |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital, Department of Samhita and Siddhanta, third Floor, Hassan , Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9880462932 |
| Fax |
|
| Email |
shailajahiwale12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalakota Sahithi |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital , Hassan , Karnataka |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital, Department of Ayurveda Samhita and Siddhanta, third floor, Hassan , Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
8985714974 |
| Fax |
|
| Email |
sahithi4949@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure/Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan, Karnataka, 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, BM Road Thanniruhalla, Hassan, Karnataka 573201 |
| 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 |
| Kalakota Sahithi |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Shalakya Tantra(ENT) OPD of the Hospital, Room number-9
Hassan
KARNATAKA |
8985714974
sahithi4949@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with diagnostic symptoms of pratishyaya.
Subjects between the age group of 16years to 40 years.
Subjects who are literate and ready to sign the consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with severe attacks of pratishyaya along with other structural deformities.
Subjects also suffering from other systemic disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A scale for diagnosing Vataja pratisyaya |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A scale for assessing treatment outcome in vataja pratisyaya |
one year |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/04/2019 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A questionnaire development survey study intended to develop a scale for assessing treatment outcome in Vataja pratisyaya. Till date among the research work done on Vataja pratisyaya there are no standard criteria or scale for assessment of Vataja pratisyaya . Mostly they are done with arbitrary scale of assessment which is varying from research to research. So there is a variation in number of assessment criteria of Vataja pratisyaya from seven to fourteen lakshanas. Hence there is a need to develop a scale for assessment of Vataja pratisyaya which can be useful even to evaluate the treatment outcome. |