| CTRI Number |
CTRI/2010/091/002944 [Registered on: 16/11/2010] |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Evaluate the role of reflexology as adjunctive therapy in the management of children with refractory Childhood Epilepsy including West Syndrome |
Scientific Title of Study
Modification(s)
|
Evaluation of reflexology as an adjunctive therapy in children with refractory Childhood Epilepsy including West Syndrome |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr D Elanchezhiyan |
| Designation |
Ph.D Student |
| Affiliation |
Dept. of Biophysics |
| Address |
Room No: 3005, 3rd Floor, PC Block,
Dept of Biophysics, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
011-26593215 |
| Fax |
011-26588641 |
| Email |
chezhiyan123@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mrs Krishna Dalal |
| Designation |
Associate Professor |
| Affiliation |
Dept of Biophysics |
| Address |
Room. No: 3005 - B, 3rd Floor, PC Block
Dept of Biophysics, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
011-26593215 |
| Fax |
011-26588641 |
| Email |
drkrishnadalal@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mrs Sheffali Gulati |
| Designation |
Additional Professor |
| Affiliation |
Dept of Pediatrics |
| Address |
Room. No: 3055, 3rd Floor, PC Block
Dept of Pediatrics, All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
011--26594679 |
| Fax |
011-26588641 |
| Email |
sheffaligulati@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| All India Institute of Medical Sciences, New Delhi. |
|
Primary Sponsor
Modification(s)
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
New Delhi
110029
India |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Elanchezhiyan |
Department of Biophysics, All India Institute of Medical Sciences, New Delhi |
Room No: 3005, 3rd Floor, PC Block,Dept of Biophysics, All India Institute of Medical Sciences-110029
New Delhi
DELHI |
011-26593215
011-26588641
chezhiyan123@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences New Delhi 110 029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Refractory Childhood Epilepsy and West syndrome, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-epileptic drugs (AEDs) alone |
Pharmacological drugs were assigned by the concerned clinician |
| Intervention |
Reflexology therapy |
Reflexology therapy of 30 minutes duration twice a day in addition to the anti-epileptic drugs (AEDs) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 6 months to 12 years
2. Presence of seizures persisting daily or more than 7 per week despite the adequate trial of at least three tolerated and appropriately chosen and used anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin.
3. Residents of Delhi/National capital region. |
|
| ExclusionCriteria |
| Details |
1.Known or suspected inborn error of metabolism, as evidenced by:
Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination
And/ or 2 or more of the following biochemical abnormalities
High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
2.Motivational or psychosocial issues in the family which would preclude compliance.
3.Systemic illness- chronic hepatic, renal or pulmonary disease.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary outcome measure will be the efficacy of adjunctive reflexology in controlling seizures. This will be assessed by comparing seizure frequency at the end of the intervention period with the baseline seizure frequency the seizure frequency will be noted according to parental seizure charts. |
3 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Change in the EEG characteristics and improvement in background of epileptiform abnormalities will be noted.
2.Change in the neural development status at the end of intervention period compared with baseline, in both groups DQ will be assessed far as possible.
3.Change in AFT: Any changes in the HRV and BPV. 4.Abnormalities to be observed in the reflex areas baseline and at the end of the intervention.
5.Side effects of reflexology if any should be noticed by parental report. |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
05/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
05/06/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized controlled (open-label) trial. In this study, eligible children will be randomized to either receive adjunctive reflexology therapy along with the on-going standard therapy with anti-epileptic medications (intervention arm), or continue to receive the standard therapy with on-going antiepileptic medications (control arm). In both phases there will be a baseline period of 1 week. The baseline period will begin with a screening visit during which investigators obtain informed consent, assessed entry criteria, and performed screening procedures. These procedures included a complete physical and neurologic history and examination (pulse, blood pressure, and body weight) and laboratory testing (blood chemistry, hematology, urinalysis, and pregnancy test if appropriate). Patients or their parents or legal guardians maintained a diary in which they recorded spasm type and frequency. These diaries were reviewed, and the baseline seizure frequency will be calculated. Patients who complete the baseline period and still meet eligibility criteria enter into the treatment period. The treatment period was composed of a 4-week up-training period and an 8-week continuation period. This will be followed by a 1 week assessment period. |