| CTRI Number |
CTRI/2016/09/007319 [Registered on: 29/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathy as add on to standard care in brain fever |
|
Scientific Title of Study
|
E,Evatuation of homeopathic
medicine as add on ro institutional managetuenr protocol for A.qt€ enceltratitis
syndrome (AES) in chil.lren |
| Trial Acronym |
AES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K Manchanda |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, Institutional area, Opp D block, Janakpuri, New Delhi.
New Delhi
DELHI
110058
India |
| Phone |
011-28521162 |
| Fax |
28521060 |
| Email |
dgccrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, Institutional area, Opp D block, Janakpuri, New Delhi.
New Delhi
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, Institutional area, Opp D block, Janakpuri, New Delhi.
New Delhi
DELHI
110058
India |
| Phone |
011-28525749 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional area, Janakpuri, New Delhi, 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area, Opp D block, Janakpuri, New Delhi. 110058
|
| Type of Sponsor |
Research institution |
|
|
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 JRSingh |
BRD Medical College and Hospital |
Clinical Research Unit(T)
Private ward room no-10-11 B.R.D. Medical College and Hospital, Gorakhpur -273013
Gorakhpur
UTTAR PRADESH |
9415213821
ctuhgkp2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Encephalitis Syndrome in children , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Institutional Management Protocol plus Homoeopathy and Institutional Management protocol alone |
All the children were given IMP for managing their symptoms and signs. Children whose parent/guardian was willing to administer add on homoeopathic medicine received individualized homoeopathic medicine in addition to Institutional Management Protocol. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
• Clinically, a fresh case of acute encephalitis is defined as a children of any age (>6 months), at any time of year with the acute onset of fever of ≤ 15 days and a change in mental status (including symptoms such as confusion, disorientation, coma, or inability to talk) AND/OR new onset of seizures.
• Written informed consent.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate homeopathic treatment (H) as an add-on to IMP as per glasgow outcome scale. |
Treatment in IPD and discharge |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Indian J Res Homoeopathy 2015;9:34-41 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute
Encephalitis Syndrome (AES) is treated through institutional management
protocol (IMP) with considerable mortality and 30-40% survivors usually have
lifelong sequelae. This study was undertaken from August 2012- February 2013 at
Paediatric ward of B.R.D. Medical College, Gorakhpur, to evaluate homeopathic
treatment (H) as an add-on to IMP in reducing the mortality, disability, and to
evolve a group of useful medicines along with their indications in treating
such patients.
One hundred and fifty one children diagnosed with AES fulfilling
inclusion and exclusion criteria were enrolled. Preliminary observational study shows that Homoeopathic
medicines with IMP have some role in reducing the mortality and morbidity in AES
patients. Further, study on comparable groups is suggested. |