| CTRI Number |
CTRI/2017/01/007685 [Registered on: 12/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of homoeopathic medicines in brain fever |
|
Scientific Title of Study
|
Effectiveness of homeopathic medicines as add on to institutional management protocol for Acute encephalitis syndrome (AES) in children: An open label randomized placebo controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRKManchanda |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area
Janakpuri
61-65 Institutional Area
Janakpuri
New Delhi
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
rk.manchanda@nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer (H)-Scientist 2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area
Janakpuri
61-65 Institutional Area
Janakpuri
New Delhi
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Research Officer (H)-Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area
Janakpuri
61-65 Institutional Area
Janakpuri
New Delhi
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy
61-65, Institutional area, opp. D block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61 to 65 Institutional Area
Janakpuri |
| 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 |
| DrA K Gupta |
Clinical Trial Unit(H) |
Room no. 9 & 10, first floor, private ward
B RD, Medical College
Gorakhpur
Uttar Pradesh
Gorakhpur
UTTAR PRADESH |
05512500473
ctuhgkp2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CCRH ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute encephalitis syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathy plus institutional management protocol |
for 15-30 days or early in the IPD
|
| Comparator Agent |
Institutional management protocol |
standard care such as anti pyretics, anti emetics, anti convulsants, IV drip, ventilator support for 15-30 days in IPD |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
• Age 6 months to less than 18 years
• Acute onset of fever,
• Change in mental status (including symptoms such as confusion, disorientation, coma or inability to talk) with /without
o new onset of seizure
o Other clinical findings may include irritability, somnolence, or abnormal behaviour greater than seen with usual febrile illness.
• Written Informed consent
|
|
| ExclusionCriteria |
| Details |
Known pre existing illness such as HIV, cancer, febrile convulsions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glasgow outcome scale
|
the study will be in IPD setting. Assessment will be done at discharge tailored to patient at 15-30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| group of homoeopathic medicines used |
at end of the study |
|
|
Target Sample Size
|
Total Sample Size="622"
Sample Size from India="622"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2013 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute Encephalitis Syndrome (AES) denotes inflammation of the brain or of meninges leading to neurological symptoms. In eastern UP since 2006, >2000 cases of AES are reported each year. Preliminary data through an exploratory observational comparative study in homoeopathy showed positive results. The main hypothesis of this open label randomized controlled trial was to evaluate the superiority of individualized homoeopathic medicine along with institutional management protocol compared to standardized institutional management protocol alone through Glasgow outcome scale. The trial was conducted in IPD setting at BRD Medical College and Hospital, Gorakhpur. The assessment was done at discharge or last follow up. |