| CTRI Number |
CTRI/2018/10/016027 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of seizures in children |
|
Scientific Title of Study
|
Efficacy of individualised homeopathic medicines in treatment of paediatric epilepsy: a double-blind, randomised, placebo-controlled trial in mutual
context of usual care |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-7751 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti Gupta |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Paediatrics; Room no. 8; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
9873443820 |
| Fax |
|
| Email |
bhartiguptanhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Ash |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Paediatrics; Room no. 8; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
dr.gautam.ash01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Ash |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Paediatrics; Room no. 8; Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
dr.gautam.ash01@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106 |
| 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 |
| Bharti Gupta |
National Institute of Homoeopathy |
OPD room 8, Dept of Paediatrics; Block–GE, Sector–III, Salt Lake, Kolkata–700106
Kolkata
WEST BENGAL |
9873443820
bhartiguptanhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathic individualised medicines in centesimal potencies |
Intervention is planned as administering indicated homeopathic medicines in centesimal potencies. Each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)- certified firm. Along with the medicines, the intervention arm will receive conventional anti-epileptic drugs. Duration of therapy: 6 months. |
| Comparator Agent |
Placebo |
This arm, along with conventional anti-epileptic drugs, will receive placebo, indistinguishable from verum. Placebo each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 6 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
a) Cases suffering from epilepsy for at least 3 months
b) Both male and female patients
c) Age between 4 and 18 years
d) Patients with seizure frequency of at least once in three months
e) Capability and willingness to give informed consent by the parents and to comply with the study procedures
f) Literate parents who can read English and/or Bengali |
|
| ExclusionCriteria |
| Details |
a) Patients with febrile convulsions
b) Patients with intractable epilepsy
c) Patients with co-morbidity, like - ADHD, mental retardation
d) A clinically significant acute or chronic disease that would hinder regular participation in the study
e) Patients who are not on anti-epileptic drugs
f) Complementary or alternative treatment used simultaneously to the study (for example acupuncture, psychotherapy etc.)
g) Homeopathic treatment for at least eight weeks for any chronic diseases
h) Cases suffering from uncontrolled systemic illness or life-threatening infections
i) Self-reported immune-compromised state
j) Patients with substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hague Seizure Severity Scale (HASS) measures severity of childhood epilepsy |
At baseline, after 3 months, and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life in Childhood Epilepsy (QOLCE-16) measure of health-related quality of life (HRQoL) |
At baseline, after 3 months, and after 6 months |
| Pediatric Quality of Life Inventory (PedsQL) measures health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions |
At baseline, after 3 months, and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
28/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden was found to be the highest in eastern, western, and southern sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries reported an overall prevalence of 6/1,000 and that in India is 5.59. We examined whether individualized homeopathic medicines (IHMs) can produce significantly different effect from placebos in treatment of pediatric epilepsy in the mutual context of standard care (SC) using anti-epileptic drugs (AEDs). It was a 6-months, double-blind, randomized, placebo-controlled trial (n=60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC (n=30) or identical-looking placebos plus SC (n=30). Primary outcome measure was Hague seizure severity scale (HASS); secondary outcomes were quality of life in childhood epilepsy (QOLCE-16) and pediatric quality of life inventory (PedsQL) questionnaires; all measured at baseline and after the 3rd and 6th months of intervention. Intention-to-treat sample was analyzed to detect group differences and effect sizes. Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were higher in the IHMs group than placebos with small to medium effect sizes, the group differences were statistically non-significant – HASS (P=1.000, two-ways repeated measure analysis of variance), QOLCE-16 (P=0.237), PedsQL (2-4 years) (P=0.432) and PedsQL (5-18 years (P=0.995). Calcarea carbonica, Ignatia amara, Natrum muriaticum and Phosphorus were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups. Group differences in the outcomes were non-significantly greater in the IHMs group than placebos with small effect sizes. Robust and independent replications are warranted. |