| CTRI Number |
CTRI/2022/03/040728 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To know the usefulness of Homoeopathic medicines in the treatment of Attention Deficit Hyperactivity Disorder. |
|
Scientific Title of Study
|
A Study on the Effectiveness of Individualized Homoeopathic Intervention in ADHD using Biomarkers & Standard Questionnaires: A single blind 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 |
Dr M Gnnanaprakasham |
| Designation |
Assistant Professor(Psychiatry) |
| Affiliation |
National Homoeopathy Research Institute in Mental Health. |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram,
Kottayam - 686532
Kottayam
KERALA
686532
India |
| Phone |
9544759518 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunny Mathew |
| Designation |
Professor |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Vinayaka Mission Homoeopathic Medical College and Hospital,
Sankari Main Road(NH - 47),
Seeragapadi, Salem - 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9448327218 |
| Fax |
|
| Email |
drsunnymathew59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Gnnanaprakasham |
| Designation |
Assistant Professor(Psychiatry) |
| Affiliation |
National Homoeopathy Research Institute in Mental Health. |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram,
Kottayam - 686532
Kottayam
KERALA
686532
India |
| Phone |
9544759518 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kottayam and its Peripheral OPDs |
|
|
Primary Sponsor
|
| Name |
M Gnnanaprakasham |
| Address |
NHRIMH, kottayam |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Gnnanaprakasham |
National Homoeopathy Research Institute in Mental health |
Department of Psychiatry,
Room no - 106/09,
Sachivothamapuram(P.O),
Kottayam - 686532
Kottayam
KERALA |
9544759518
drgprakashpsy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRIMH/IEC |
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 |
| Intervention |
Any one Individualized/Personalised Homoeopathic Medicine at a time(Nux.vomica, Medorrhinum, Tarentula. Hispanica, Zinc. metallicum, Pulsatilla,Phosphorus, Arsenic Album, Natrum.muriaticum, Sepia,lachesis etc., ) |
Dose/potency - 6c,30c, 200c and 1M.
Frequency - Monthly 1 dose,(in 6c/30c/200c/1M).
Repetition - Monthly 1 dose and as per the need of the case.
Route of Administration - Oral.
Duration of therapy - 1 year. |
| Comparator Agent |
Plain/unmedicated Placebo packets |
Dose/potency - Not applicable
Frequency, repetition and duration - same as medicine group. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. The cases between age group of 03 – 14 years of age
2. Both sexes
3. Confirmed to DSM- 5 diagnostic criteria for ADHD |
|
| ExclusionCriteria |
| Details |
1. Cases with chronic medical conditions,
2. Congenital anomalies/Disorders,
3. Seizures or any other serious physical illness,
4. Other Co morbid psychiatric conditions,
5. Patients not willing to give consent,
6. Patients under psychoactive drugs in the past
two weeks |
|
|
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 |
| To determine the overall improvement of the ADHD symptoms and general improvement of the patient using Homoeopathic follow up analysis/sheet after administration of the remedy. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Difference in ADHD Rating Scale IV and Weiss functional impairment scale |
01 year |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2022 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drgprakashpsy@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title A study on the Effectiveness of Individualized Homoeopathic Intervention in ADHD using Biomarkers & Standard Questionnaires: A Single blind randomized Placebo controlled trial.
Aim To know the effectiveness of Individualized Homoeopathic Medicines in the management of ADHD patients.
Methodology Single blind Randomized Placebo Control Trial
Study Duration Enrolment - 09 months Follow up - 12 months Data Compilation & Publication - 03 months.
Objectives 1. To understand the therapeutic impact of Homoeopathic Individualized drug potencies in ADHD. 2. To know the relationship between the abnormal readings of biomarkers in cases diagnosed with ADHD and to propose a hypothesis to relate the ADHD symptoms and biomarkers in relation to homoeopathic drug effects.
Study Centre National Homoeopathy Research Institute in Mental Health, kottayam
Sample Size 64 Participants. (32 homoeopathic intervention and 32 Placebo group)
Assessment Tools used 1. Conners abbreviated rating scale 2.ADHD Rating scale IV - Home and Teacher Version 3.Weiss Functional Impairment Scale - Self and Parent version 4.Biomarkers - S. Lactate, S. Ammonia, S. Ferritin, S. Zinc
Outcome To understand the effectiveness of Individualized homoeopathic medicines in treating ADHD patients through difference in the scores of assessment tools, Homoeopathic follow up analysis/sheet and general improvement of the patient.
|