| CTRI Number |
CTRI/2024/07/070244 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on applicability of homoeopathic medicine Tarentula hispanica in symptoms of Attention Deficit Hyperactivity Disorder with synthesis repertory |
|
Scientific Title of Study
|
Clinical Verification of Rubrical Representation of Attention Deficit Hyperactivity Disorder related symptoms of Tarentula hispanica in Synthesis Repertory |
| 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 Surya Gayathri V |
| Designation |
Post graduate student |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
2nd Floor College Building, Room No 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9497504332 |
| Fax |
|
| Email |
suryagaya3v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Sankar A S |
| Designation |
Professor |
| Affiliation |
Department of Repertory Sarada Krishna Homoeopathic Medical College |
| Address |
2nd Floor College Building, Room No 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Sankar A S |
| Designation |
Professor |
| Affiliation |
Department of Repertory Sarada Krishna Homoeopathic Medical College |
| Address |
2nd Floor College Building, Room No 301, Department of Repertory, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443500675 |
| Fax |
|
| Email |
dissert02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Kulasekharam Kanniyakumari District, Tamil Nadu-629161,India |
| Type of Sponsor |
Private medical college |
|
|
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 Surya Gayathri V |
Sarada Krishna Homoeopathic Medical college Hospital |
Room No 105, 4B Unit-Repertory Outpatient Department and Inpatient Department of Repertory Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU |
9497504332
suryagaya3v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F909||Attention-deficit hyperactivity disorder, unspecified type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tarentula hispanica |
Homoeopathic medicine Tarentula hispanica will be prescribed. Daily one dose of medicine will be administered orally. Follow-up of the case will be observed once in every 15 days.The research will be done for the period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptomatology of Tarentula hispanica
All types of diagnostic cases of Attention Deficit Hyperactivity Disorder |
|
| ExclusionCriteria |
| Details |
Age above 19 years
Patients having other behavioral diseases
Patients with severe systemic illness
Children under long term medication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out reliability of rubrics related to ADHD representing Tarentula hispanica in synthesis repertory
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in symptoms of Attention Deficit Hyperactivity Disorder with respect to time in every 2 weeks
Changes in the symptoms of Attention Deficit hyperactivity disorder of Tarentula hispanica in synthesis repertory every 3 months
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Attention Deficit Hyperactivity Disorder is a prevalent neurodevelopmental disorder nowadays. Early diagnosis and treatment of Attention Deficit Hyperactivity Disorder in children is necessary to reduce risk of complication in later years. The need of this study is to prove potential role of Tarentula hispanica in the management of symptoms of attention deficit hyperactivity disorder in synthesis repertory. This study focuses on verification of rubrics related to Attention Deficit Hyperactivity Disorder of Tarentula hispanica in synthesis repertory. The rubrics related to Attention Deficit Hyperactivity Disorder with representation of Tarentula hispanica is available in synthesis repertory . The reliability of rubrics related to Attention Deficit Hyperactivity Disorder with representation of Tarentula hispanica is yet to be verified. Daily one Dose of Tarentula hispanica will be administered orally with a regular follow-up in every 2 weeks. The study will be conducted for the period of 6 months. The case will be assessed using Vanderbuilt Diagnostic Parent Rating Scale. The reliability is verified through observing the clinical course of Attention Deficit Hyperactivity Disorder during treatment with Tarentula hispanica and also changes in symptom with respect to time. The study will be statistically analyzed by using paired t test. |