| CTRI Number |
CTRI/2018/11/016408 [Registered on: 22/11/2018] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Other |
|
Public Title of Study
|
This is an observational study conducted to observe how subjects with dizziness and dizziness associated symptoms are managed in primary care setting in India. |
|
Scientific Title of Study
|
A multicenter, non-interventional, observational registry to determine clinicoepidemiological profile and management practices of dizziness in primary care setting in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamalakannan |
| Designation |
Prinical Investigator |
| Affiliation |
RKK Medical Center |
| Address |
RKK Medical Center 1158, 57th Street TNHB Colony Korattur, Chennai-.
Chennai
TAMIL NADU
600080
India |
| Phone |
|
| Fax |
|
| Email |
drrkkgp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamalakannan |
| Designation |
Investigator |
| Affiliation |
RKK Medical Center |
| Address |
RKK Medical Center 1158, 57th Street TNHB Colony Korattur, Chennai
Chennai
TAMIL NADU
600080
India |
| Phone |
|
| Fax |
|
| Email |
drrkkgp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Nair |
| Designation |
Head of Clinical Operation |
| Affiliation |
Abbott Healthcare.Pvt. Ltd |
| Address |
Abbott Healthcare.Pvt. Ltd
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E),Mumbai – 400 051
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
|
| Fax |
|
| Email |
sneha.nair@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd.
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051
|
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Ltd |
| Address |
Abbott Healthcare.Pvt. Ltd
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E),Mumbai – 400 051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamalakannan |
Dr. Kamalakannan |
RKK Medical Center 1158, 57th Street TNHB Colony Korattur, Chennai-600080.
Chennai
TAMIL NADU |
9841037574
drrkkgp@gmail.com |
| Dr Jayprakash Kewalani |
Dr.Jayprakash Kewalani |
Clinic, 685/4, Near Bhola Surgical, Kaala Bazar, Ajmer, Rajashthan-305001
Jaipur
RAJASTHAN |
7737651589
drjaiprakashkewlani@gmail.com |
| DrSaravanan |
Dr.Saravanan |
CS Clinic 66Kovilpathagai Main Road, Kovil Pathgai Avadi, Chennai- 600 062.
Chennai
TAMIL NADU |
9841167335
getdrcs@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethic Committee |
Approved |
| Royal Pune Independent Ethic Committee |
Approved |
| Royal Pune Independent Ethic Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult male and female patients (aged ≥18 years) presenting with dizziness in primary care
2. Patients willing to participate in the registry and provide informed consent for participation
3. Patients who are willing and competent to sign and date a patient authorization form (PAF) for participation in the study |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Patients with dizziness requiring hospitalization for any cause
3. Any condition that in the opinion of the investigator does not justify the patient’s inclusion in the study
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
To determine clinicoepidemiological profile of patients presenting with dizziness in the primary care setting
|
1. Base to Week 1
2. Baseline to Week4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Management practices
a. Number and percentage of patients advised to undergo routine assessments/advanced
assessments
b. Number and percentage of patients being advised lifestyle modification (change in
smoking habit/alcohol consumption/diet/exercise/both), and/or pharmacotherapy (betahistine,
prochlorperazine and cinnarizine monotherapy, and cinnarizine fixed dose combination
therapy) and/or referred to specialists for further management |
Number and percentage of patients advised for advanced assessment or lifestyle modification -From 1. Baseline to week1 , 2. Week1 and week4.
|
|
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Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1000"
Final Enrollment numbers achieved (India)="1000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2018 |
| Date of Study Completion (India) |
07/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/06/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This registry has been planned to determine the socio-demographic and clinical characteristics of patients presenting with dizziness in primary care. We also plan to determine the management practices for dizziness in primary care. This is a Dizziness registry , there are Visit 1 (Baseline),Visit 2 (face-to face interview) or telephonic follow-up (Week 1±2 days), where there will be 1000 subjects enrolled across 20-30 sites. This will be assessed by performing Level of disability score: The level of disability caused by dizziness will be evaluated by physicians through patient interview as follows during every study visit.
i. 0 = No disability; negligible symptoms ii. 1 = No disability; bothersome symptoms iii. 2 = Mild disability; performs usual work duties, but symptoms interfere with outside activities iv. 3 = Moderate disability; symptoms disrupt performance of both usual work duties and outside activities v. 4 = Recent severe disability; on medical leave or had to change job because of symptoms |