| CTRI Number |
CTRI/2023/05/052888 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pattern of prescription in cases witn epilepsy |
|
Scientific Title of Study
|
An observational study for pattern of prescription in cases with epilepsy at sms hospital jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dilip Ganwani |
| Designation |
Resident |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of pharmacology sawai man singh medical college jln marg jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9664316904 |
| Fax |
|
| Email |
dilipganwani27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Bhargava |
| Designation |
Senior professor |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of pharmacology sawai man singh medical college jln marg jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7877755835 |
| Fax |
|
| Email |
drjyotsna1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Ganwani |
| Designation |
Resident |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of pharmacology sawai man singh medical college jln marg jaipur
RAJASTHAN
302004
India |
| Phone |
9664316904 |
| Fax |
|
| Email |
dilipganwani27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of neurology, sms medical college Jaipur |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Government 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 dilip ganwani |
Sawai man singh medical college |
Room no 106, Department of neurology, Sawai man singh medical college and hospital jln marg Jaipur
Jaipur
RAJASTHAN |
9664316904
dilipganwani27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex who came in Neurology OPD, diagnosed with any type of epilepsy with age more than or equal to 18 years. |
|
| ExclusionCriteria |
| Details |
1. Patient or relative of cases not willing to sign informed consent form. 2. Patients with incomplete information.
3. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the drug prescribing pattern of antiepileptic drugs as per WHO core prescription indicators:-
a. Average number of drugs per encounter.
b. Percentage of drugs prescribed by generic names.
c. Percentage of encounters with an injection prescribed. d. Percentage of drugs prescribed from essential drug list.
2) To estimate the proportion of cases where drugs were prescribed according to standard treatment guidelines |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) 2) 3) 4)
5) 6)
To evaluate the socio-demographic indicators of epilepsy.
To evaluate the associated co-morbidities in epileptic patients.
To estimate the proportion of cases with potential drug-drug interactions.
To evaluate the prescribing drug regimen in epileptic patients : mono vs dual vs poly therapy.
To evaluate the commonly prescribed adjuvant drugs in epileptic patients. To sensitize the patients about ADR reporting. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
30/05/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study of prescription pattern of antiepileptic drugs at sms medical college and hospital, jaipur. The outcome measures will be to evaluate the drug prescribing pattern of antiepileptic drugs as per WHO core prescription indicators, average number of drugs per encounter, percentage of drugs prescribed by generic names, percentage of encounters with an injection prescribed, percentage of drugs prescribed from essential drug list, to estimate the proportion of cases where drugs were prescribed according to standard treatment guidelines. |