Health Condition 1: null- Intractable Epilepsy
Conditions
Interventions
Intervention1: Anti-epileptic Drugs (AEDs)& real Reflexology therapy: The intervention will be done by the real or placebo Reflexology therapy in active group or control group respectively. Duration o
Sponsors
Department of Biotechnology NER DIVISION
Eligibility
Inclusion criteria
Inclusion criteria: •The patients who will follow the following conditions will be included in the trial: •They should be the residents within 100 km around each of the centers. This is required because the response of the patients will be required to be monitored. •During the period of initial 1week, the patients together with caregivers of both arms will be admitted in the centre for training and recording all the clinical parameters at the baseline •The patients who will be able to have the therapy done by their caregivers. •The patients who will under the age group as mentioned above. •Either of sex •Patients with a minimum 2 seizures per month •The patients who fulfill the criteria for epileptic seizure •On 2 AEDs with at least one newer AED with an observation for a period of 6 months in each combination (prior to admitting the patients in the trial) •The patients who will not refuse but will be willing to submit, of their own, the filled-in informed consent proforma.
Exclusion criteria
Exclusion criteria: •Any kind of organ removal from the patientâ??s body due to any reason •Malignancy of any kind •Brain tumor •Tuberculosis •HIV- infection •Patients with progressive etiology of epilepsy •The patients who will refuse to submit the filled-in informed consent proforma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Percentage in Seizure frequency reduction (R) b.Quality of life in epilepsy (QOLIE)QOLIE-31 : for ages 18 yrs to 60yrs Child behaviour check list: for ages 5 to 6 years and 6 to 18 yearsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Average no. of AEDs during last 3months prior to trial â?¢Change in number and type of AEDs during follow-up period â?¢Side effects of AEDs and reflexology â?¢Difficulty/pain in lower- limb movement by visual analogue Scale (VAS) at the end of follow-up w.r.t. that at base line â?¢Abnormalities to be observed in the reflex areas â?¢Genetic history by drawing the family tree in individual patient. â?¢Control of urine and Sleep pattern â?¢Digestive system functionTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Mrs Krishna Dalal
All India Institute of Medical Sciences
Outcome results
None listed