| CTRI Number |
CTRI/2022/07/043666 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualized homoeopathic treatment along with non-pharmacological care in Children with ADHD |
|
Scientific Title of Study
|
Effectiveness of Individualized homoeopathic treatment along with non-pharmacological care in Children with ADHD – Pragmatic open label Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Singh |
| Designation |
Research Officer (Homeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional area, Jwahar lal nehru bhartiya chiktsa avum homoeopathic anusandhan bhawan, Ayush building, Opp D block Janak Puri.
West
DELHI
110058
India |
| Phone |
9818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Singh |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Technical department, room no 312
61-65, Institutional Area, Jwahar lal nehru bhartiya chiktsa avum homoeopathic anusandhan bhawan, Ayush building,Opp D block Janak Puri
West
DELHI
110058
India |
| Phone |
9818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siva Prasad Goli |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Homoeopathy Research Institute for Disabilities (HRID), Room No. 136, N.I.E.P.M.D Campus, ECR Road, Muttukadu, Chennai- 603112
Chennai
TAMIL NADU
630112
India |
| Phone |
9550368653 |
| Fax |
|
| Email |
drsivahomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homeopathy, 3rd floor, room no 408,
61-65, Institutional area, Jawahar Lal Nehru bhartiya chikitsa avum homoeopathic anusandhan bhawan, Sewa Marg, Opp D Block Janakpuri,
New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homeopathy |
| Address |
3rd Floor, Jawaharlal Nehru Bhartiya Chikitsa avum Homoeopathic anusandhan Bhawan, 61-65 Institutional area, Opp D Block Janak Puri
new Delhi-110059 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Siva Prasad Goli |
Homoeopathy Research Institute for Disabilities (HRID) |
Homoeopathy Research Institute for Disabilities (HRID), Homoeopathy department, Room no 136, NIEPMD campus, ECR road, Muttukadu, Chennai 603112
Chennai
TAMIL NADU |
9550368653
drsivahomoeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The non-pharmacological standard care including Occupational Therapy, Speech therapy, and Behavioural modification will be advised and provided by a clinical psychologist from NIEPMD, Chennai as per the need of the case. |
| Intervention |
Homoeopathy group with the indicated homeopathic treatment by the homeopathic physician along with non-pharmacological care including Occupational Therapy, Speech therapy, and Behavioral modification provided by a Consultant/ clinical psychologist.
|
Homoeopathic drugs as detailed in the standard Homoeopathic Materia Medica and in the Homoeopathic Pharmacopoeia (India/US) will be used in the study based on symptom similarity (Homoeopathic principle).
The drugs identified for the trial shall be procured from a GMP-compliant pharmaceutical firm approved by the Council. Homoeopathic Medicine shall be given in 30C, 200C or 1M potency as per the prescribing totality of the case. Medicines will be dispensed in sugar globules of standard size 30.
Medicine shall be given orally and the total duration will depend on the individual case, as per the principle of Homoeopathy.
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnostic criteria of DSM V for ADHD confirmed by a clinical psychologist.
2. Intelligence Quotient (IQ) is above 35 (to be calculated using Binet Kamat test of Intelligence or any other test or if already available from medical records)
3. Patients willing and able to take homeopathic medicines (liquid or pills form)
4. Parents/guardians willing to give written consent and agree to monthly follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Having any other known severe systemic illnesses like TB, HIV, or any additional mental health disorder like ASD, Conduct disorder, etc.
2. Currently taking Conventional medicine for ADHD like Atomoxetine, Methylphenidate, and Dexamphetamine or have taken in previous two weeks.
3. Any history of suicidal tendency, major drug abuse, or addiction to any substance.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Conners Parent rating scale-revised(L) in Homoeopathy group when compared to control group |
Conners Parent rating scale-revised(L): 0,3,6,9,12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in sleep pattern in response to homeopathic treatment in ADHD with respect to control group using Children Sleep habits Questionnaire (CHSQ) by parent
Change in overall functioning in response to homeopathic treatment in ADHD
Relation between ADHD development and maternal Pregnancy ailments.
|
WHO DAS 2.0 Monthly
Children Sleep habits Questionnaire (CHSQ) at three months intervals till 12months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Conventional treatment for ADHD consists of medication as well as behavioural interventions with educational accommodations to enhance the learning of the patient as well as the parents. Stimulants improve ADHD symptoms in most children; however, children either do not respond to this class of drug or are unable to tolerate them due to the wide range of adverse effects they may produce. Research studies conducted so far support the therapeutic effect of individually selected homoeopathic medicines in children with ADHD. The current study is a Pragmatic open-label Randomized Control Trial to evaluate response to homoeopathic treatment along with non-pharmacological care in Children with ADHD with respect to symptom reduction when compared to the control group with standard nonpharmacological care i.e. Occupational Therapy, Speech therapy, Behavioural modification as an integrated approach in reducing the symptom severity in children with ADHD and improve their general health, sleep patterns as well as overall functioning when compared to control group receiving standard non-pharmacological care (Occupational Therapy, Speech therapy, Behavioural modification) only. The study is ethically approved by the central ethics committee and the scientific committee of the council.
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