| CTRI Number |
CTRI/2024/08/072191 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical trial to study the effects of myoinositol on seizure frequency in drug resistant epilepsy patients. |
|
Scientific Title of Study
|
Effects of myoinositol supplementation on seizure frequency in person with drug resistant epilepsy:A double blind randomized N-of-1 trial |
| 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 Saket Yadav |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences ,New Delhi |
| Address |
Room no. 5003 D, Convergence block, Dept. of Pharmacology, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9079684509 |
| Fax |
|
| Email |
sakety67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Chandra Sarangi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pharmacology ,All India Institute of Medical Sciences New Delhi ,Room no. 5009 convergence block ,5th floor
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
scsarangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences ,New Delhi |
| Address |
Room No.705,Department of Neurology,All India Institute of Medical Sciences,New Delhi
New Delhi
Delhi
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8518881757 |
| Fax |
|
| Email |
mantriaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,New Delhi
Delhi
110029
India |
|
|
Primary Sponsor
|
| Name |
Dr Saket Yadav |
| Address |
Room no. 5003 D, Convergence block, Dept. of Pharmacology, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Saket Yadav |
All India Institute of Medical Sciences,New Delhi |
Department of Pharmacology, Room No. 5003D,Convergence Block
Room No. 4 and 5, Ground Floor, Department of Neurology,
Epilepsy Clinic
New Delhi
DELHI
110029
New Delhi
DELHI |
9079684509
sakety67@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
| Institutional Ethics committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matching placebo |
All the six Patients of placebo control arm will receive placebo equivalent to myoinositol supplementation along with ongoing
antiepileptic drugs for six months of duration |
| Intervention |
Myoinositol |
All the six participants will be given myoinositol 6gm twice daily for Six months along with ongoing antiseizure medications. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed persons with drug resistant epilepsy
2. Either gender 18-45 year
3.Able to maintain seizure diary
|
|
| ExclusionCriteria |
| Details |
1. Any other neurological disease
2.Status epileptics within 3 months prior to enrollment or during treatment period
3.Person with kidney failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the percentage change in seizure frequency after every month for the six months with alternating monthly treatment cycle of myoinositol or placebo drug resistant epilepsy patients. |
Six months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
A.To find out the effect of myoinositol on epileptogenesis by estimation of various biomarker such as:
1.EEG evaluation
2.HMIT cotransporter
3.PI3k biomarker
4.IGF-1 biomarker
B.To find out the variation in hba1c level
C.To find out the safety of myoinositol intervention through monthly assessment of:
1.Safety monitoring (ADR assessment,Liverpool adverse event profile(LAEP)scoring,DASs-21,Quality of life index in epilepsy(QOLIE-10)
2.Liver & renal function test |
Six months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
21/08/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This study is being conducted to asses the percentage change in seizure frequency in drug resistant epilepsy patients after alternative therapy of myoinositol/palcebo every month and to find effect of myoinositol on various biomarker in epilpetogenesis such as EEG evaluation ,HMIT cotransporter, PI3k biomarker , IGF-1 biomarker. To find out the effect of myoinositol in epilepsy.To find out the safety of myoinositol intervention through monthly assessment of safety monitoring (ADR assessment ,Liverpool Adverse event profile ,DASS-21,BPAQ and quality of life index in epilepsy (QOLIE-10),seizure severity scale,duration of days with seizure freedom, liver and renal function test.Randomisation was done based on age,sex,seizure frequency, type of epilepsy.All patients are counselled for life style, including diet, not to change the regular diet habit during whole double blind study period. subjects are asked to avoid alcohol and smoking. |