| CTRI Number |
CTRI/2018/12/016615 [Registered on: 11/12/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood level of drug in Epilepsy |
|
Scientific Title of Study
|
Estimation of Phenytoin Concentration in Epileptic Patients with Adequate Seizure Control in North-East India- a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Julie Birdie Wahlang |
| Designation |
Assisstant professor |
| Affiliation |
NEIGRIHMS |
| Address |
Department of Pharmacology, Directors Block Neigrihms Mawdiangdiang Shillong793018
nongshiliang, nongthymmai,Shillong 793014
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
08794732665 |
| Fax |
|
| Email |
juliewahlang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Julie Birdie Wahlang |
| Designation |
Assisstant professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences |
| Address |
Department of Pharmacology, Directors Block Neigrihms Mawdiangdiang Shillong793018
nongshiliang, nongthymmai Shillong793014
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
08794732665 |
| Fax |
|
| Email |
juliewahlang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Julie Birdie Wahlang |
| Designation |
Assisstant professor |
| Affiliation |
NEIGRIHMS |
| Address |
Department of Pharmacology, Directors Block Neigrihms Mawdiangdiang Shillong793018
nonshiliang, nongthymmai,Shillong 793014
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
08794732665 |
| Fax |
|
| Email |
juliewahlang@gmail.com |
|
|
Source of Monetary or Material Support
|
| North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
|
|
|
Primary Sponsor
|
| Name |
NEIGRIHMS |
| Address |
Mawdiangdiang,
Shillong -793018
Meghalaya
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| julie wahlang |
North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences |
Department of Pharmacology
Directors block
Mawdiangdiang shillong 793014
East Khasi Hills
MEGHALAYA |
8794732665
juliewahlang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, NEIGRIHMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the cases of Epilepsy treated in the Department of Neurology who are seizure free in NEIGRIHMS will be included. |
|
| ExclusionCriteria |
| Details |
Patients without phenytoin therapy
2. Patients with another AED.
3. Patients with concomitant diseases and medications.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will provide the target level of phenytoin that is required for obtaining satisfactory clinical outcome with minimal adverse effect in our setting. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help our physicians in delivering better therapy unique to our population in this part of the country. |
one year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
16/12/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Studies which have been conducted in India to evaluate the standard patient care through assessment of therapeutic drug monitoring in patients with seizure period are lacking. No such studies have been reported from North East region of India, so the rationale of adequate seizure control with drugs is yet to be ascertained. |