| CTRI Number |
CTRI/2024/08/072742 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on usefulness of Homoeopathic Medicines in reducing the Behavioral problems of adults with Intellectual Disability |
|
Scientific Title of Study
|
A prospective open label single arm study on Individualized Homoeopathic Medicines in reducing the Challenging Behavior among adults with Intellectual Disability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisma K U |
| Designation |
PG Scholar |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, sachivothamapuram P O, kurichy , Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9400941702 |
| Fax |
|
| Email |
nismaku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja K R |
| Designation |
Assistant Professor |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, sachivothamapuram P O, Kurichy, Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9495105766 |
| Fax |
|
| Email |
jaisankarsreeja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeja K R |
| Designation |
Assistant Professor |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, sachivothamapuram P O, Kurichy, Kottayam |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9495105766 |
| Fax |
|
| Email |
jaisankarsreeja@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health
Sachivothamapuram P O
Kurichy
Kottayam District
Kerala
India
PIN:686532 |
|
|
Primary Sponsor
|
| Name |
Nisma K U |
| Address |
National Homoeopathy Research Institute in Mental Health Sachivothamapuram P O
Kurichy
Kottayam
Kerala
India
PIN:686532 |
| 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 |
| Dr Nisma K U |
National Homoeopathy Research Institute in Mental Health |
OPD, IPD, Peripheral and Special Camps,Department Of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O, Kurichy, pin:686532
Kottayam
KERALA |
9400941702
nismaku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- National Homoeopathy Research Institute in Mental Health, Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70-F79||Intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Medicine will be given orally in minimum dosage as per the Homoeopathic principles for 1 year on a monthly basis |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with Intellectual Disability as per DSM 5 criteria.
Participants having score ≥ 6 for at least one item under the subscales SIB/DAB or a score
of 4 for at least one item from SB subscale in BPI-S scale. |
|
| ExclusionCriteria |
| Details |
1. ID patients with psychosis and severe depression
2. Participant with any serious systemic diseases.
3. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in the severity of Challenging behavior after the administration of individualized homoeopathic medicine using BPI-S scale |
once in 3 months for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in behavioral problems after the administration of Individualized Homoeopathic Medicine using PART B of BASAL MR |
Baseline and after the completion of the study |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
28/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All patients who present with the symptoms of ID at OPDs, IPDs, peripheral or special camps of NHRIMH, Kottayam shall be screened with Verbal screening Questionnaire.. Those subjects who have done IQ priorly shall be considered and those who have not done their IQ assessment shall be made to do an apriori IQ assessment by the qualified clinical psychologist for the purpose of partial fulfillment of diagnostic criteria. Diagnostic confirmation will be done by consultant psychiatrist of the institution. Participant information sheet will be given and written informed consent shall be received from willing individuals having insight and from the legally authorized representative if the individual lacks insight. Detailed case-taking will be done on the case recording format. Challenging behavior shall be assessed using BPI-S. Those individuals whose score ≥ 6 for at least one item under the subscales SIB/DAB or a score of 4 for at least one item from SB subscale shall be enrolled for the study. Assessment of BASAL MR- PART B will be done at baseline for the enrolled subjects. Totality of symptoms will be erected and repertorisation will be done with appropriate repertory as per the requirement of the case. Final selection of the medicine will be done after comparing it with Homoeopathic Materia Medica. IHM shall be prescribed in suitable potency based on the susceptibility of the patient at baseline. The dose and repetition of medicine in the follow up visits will be done based on Homoeopathic principles. If there is no change at all, the case shall be retaken, and another appropriate medicine will be prescribed. If any acute complaint arises, appropriate medicine will be administered based on the acute totality and 9 shall be recorded in the follow-up sheets. Telephonic consultation will be done as per the need of the patient or if there are no follow-up visits for 2 months. If there is no follow up for 3 consecutive months, the case is considered as drop out. If drop out cases returning for treatment will be given regular treatment but will not include in the study further. Those who are willingly withdrawn from the study will also be given regular treatment but will not consider them for the purpose of study analysis. Post-trial care shall be given in the regular OPDs of NHRIMH. |