| CTRI Number |
CTRI/2011/12/002305 [Registered on: 28/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A pilot study to see the effectiveness of homoeopathic therapy in attention Deficit Hyperactive Disorder of children |
|
Scientific Title of Study
|
Homoeopathic management for Attention Deficit Hyperactivity Disorder in children: A Randomized Placebo Controlled Pilot Study |
| Trial Acronym |
ADHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Chaturbhuja Nayak |
| 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
India
South West
DELHI
110058
India |
| Phone |
01128525523 |
| Fax |
01128521060 |
| Email |
drcbnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Assistant Director (H) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy,
61 - 65, Institutional Area,
Opp. D- Block, Janakpuri,
New Delhi
India
South West
DELHI
110058
India |
| Phone |
9811952274 |
| Fax |
01128521060 |
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Assistant Director (H) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy,
61 - 65, Institutional Area,
Opp. D- Block, Janakpuri,
New Delhi
India
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 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 |
| DrSGopinadhan |
Central Research Institute (H) |
Sachivothampuram
Kottayam
KERALA |
04812432238
dr.sgopinadhan@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 |
Attention Deficit Hyperactivity Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
LM potency-15 ml once daily or as and when required orally for 1 year |
| Comparator Agent |
placebo |
15 ml once daily or as and when required orally for 1 year |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 6-15 years and meeting Diagnostic and statistical Manual of mental Disorders- 4th edition (DSM-IV) criteria. |
|
| ExclusionCriteria |
| Details |
1 Co-morbid medical or other psychological conditions (Psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive disorder, and severe anxiety disorder).
2Any chronic physical or neurological disorder
3 History of drug abuse
4 History of Seizure
5 History of Tic disorder
6 History of Tourette syndrome
7Patients who were on anti-ADHD or psychoactive medications in the last two weeks.
8 Any severely ill patient requiring hospitalization.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Global impession-Severity and Clinical Global impression-Improvement
Conners parent rating Scale-revised |
Baseline, Monthly, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To deduce feasibility of study design and to gather data for sample size calculation of definitive study |
completion |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2009 |
| 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="6"
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
|
A multicenteric single blind randomized placebo controlled trial shall be carried out to evaluate the efficacy of individualized homoeopathic therapy in the management of Attention Deficit Hyperactivity Disorder (ADHD), at one of the Institutes of Central Council for Research in Homoeopathy. Children in the age group of 6 years to 15 years, fulfilling the criteria of DSM-IV for ADHD shall be enrolled in the study. Individualized homoeopathic medicines in LM potency shall be prescribed to half of the enrolled patients whereas other half shall receive placebo. Severity of disease shall be rated on Conners parent rating scale-Brief and Clinical global impression scale, at the time of enrolment and on each subsequent follow-up visits. All enrolled patients shall be followed up for one year. |