| CTRI Number |
CTRI/2024/04/065939 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Bacopa Monneiri, Attention deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
EFFICACY OF BACOPA MONNEIRI IN ATTENTION DEFICIT
HYPERACTIVITY DISORDER IN SCHOOL & COLLEGE
GOING AGE GROUP : RANDOMISED CONTROLLED TRIAL
USING SNAP-IV SCORE |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saroj Ranjit Sawant |
| Designation |
PhD Scholar |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Homoeopathic materia medica department
YMT Homoeopathic Medical College Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
416210
India |
| Phone |
9604656093 |
| Fax |
|
| Email |
drsarojsawant212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saroj Ranjit Sawant |
| Designation |
PhD Scholar |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Department of Homoeopathic Materia Medica
YMT Homoeopathic Medical College Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9604656093 |
| Fax |
|
| Email |
drsarojsawant212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Makarand Bhagwat |
| Designation |
Professor PhD Guide |
| Affiliation |
Maharashtra University of Health Sciences Nashik |
| Address |
Department of Homoeopathic Materia Medica
YMT Homoeopathic Medical College Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9969337242 |
| Fax |
|
| Email |
ymthmc01@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Homoeopathic Medical College Kharghar Navi Mumbai Maharashtra 416210 |
|
|
Primary Sponsor
|
| Name |
Dr Saroj Ranjit Sawant |
| Address |
Department of Homoeopathic Materia Medica |
| Type of Sponsor |
Other [Scholar 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 |
| DR SAWATI MAKARAND BHAGWAT |
YMT Homoeopathic Medical College |
PhD Department
Homoeopathic Materia Medica
Mumbai
MAHARASHTRA |
9969337242
ymthmc01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT HOMOEOPATHIC MEDICAL COLLGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacopa Monneiri Homoeopathic Medicine |
Bacopa Monneiri
Potency 1 X
Route of Administration Oral
Dose 1 tablet to times a day
Duration 6 month |
| Comparator Agent |
Placebo |
Homoeopathic placebo Tablets
Route of Administration Oral
Dose 1 to times a day
Duration 6 month |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children & young persons of a mixed variety of Attention Deficit Hyperactivity Disorder as per DSM 5 Criteria
Children & young persons of WITH ENLISH Literate Parents |
|
| ExclusionCriteria |
| Details |
Children with any chronic physical or neurological disorder
History of drug abuse
History of seizure
History of Tic disorder
History of Tourette syndrome
Severely ill in need of hospitalization and patients who are on anti ADHD or psychoactive medications in the previous 2wks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Swanson Nolan And Pelham Rating Scale
SNAP IV 26 items |
PRESTUDY MIDSTUDY POSTSTUDY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
27/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - drsarojsawant212@gmail.com
- For how long will this data be available start date provided 03-05-2025 and end date provided 03-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Efficacy of Bacopa Monneiri in ADHD in school going & college going age group will be studied by Randomized controlled clinical trial using outcome assessment SNAP IV score. The sample size whole study will be 100 cases, |