| CTRI Number |
CTRI/2024/10/075036 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A Study to assess Prakriti in individuals with Respiratory allergies consuming specific type of viruddha ahara |
|
Scientific Title of Study
|
An Observational Study To Assess The Prakriti In Individuals With Respiratory Allergy Consuming Specific Types Of Viruddha Ahara |
| 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 Sudharseni P |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department Of Kriya Shareera
Government Ayurveda College Pariyaram,
Kannur
Kannur
KERALA
670503
India |
| Phone |
9442626929 |
| Fax |
|
| Email |
sudhatrp96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department Of Kriya Shareera
Government Ayurveda College Pariyaram,
Kannur
Kannur
KERALA
670503
India |
| Phone |
9442626929 |
| Fax |
|
| Email |
drpradeep601@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudharseni P |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department Of Kriya Shareera
Government Ayurveda College
Pariyarm,
Kannur
Kannur
KERALA
670503
India |
| Phone |
9442626929 |
| Fax |
|
| Email |
sudhatrp96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kriya Sarrira
Government Ayurveda college, pariyaram
kannur, kerala
670503 |
|
|
Primary Sponsor
|
| Name |
Dr SUDHARSENI P |
| Address |
Government Ayurveda College and Hospital, Pariyaram
Kannur,kerala
670503 |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Sudharseni P |
Government Ayurveda College and Hospital, Kannur |
OPD and IPD Of all Departments
Kannur
KERALA |
9442626929
sudhatrp96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Ayurveda College, Pariyaram Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VIRUDDHANNABOJANAM/VIRUDDHAHARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individual with respiratory allergies as per diagnostic criteria, who consuming specific type of viruddha ahara
Who provide informed consent |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating women
Individuals with psychological morbidity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prakriti of an individual with respiratory allergies consuming specific viruddha ahara
|
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation with prakriti & viruddha aahara |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
19/10/2024 |
| 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 Applicable |
| 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
|
Determining
the prakriti in individuals more
prone to allergic respiratory disease by consuming specific viruddha ahara, the onset of respiratory
allergies could be prevented with dietary and lifestyle modifications. Hence,
this study will assess the Prakriti
in individuals with respiratory allergies consuming specific types of viruddha
ahara |