| CTRI Number |
CTRI/2024/07/070239 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Management of quality of life in Post Cerebro vascular accident with Homoeopathy |
|
Scientific Title of Study
|
A comparative study on enhancing the quality of life in Post Cerebrovascular accident using homoeopathic medicine and patients under conventional medicine |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani.K |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine White Memorial Homoeopathic Medical College and Hospital
Attoor,
Veeyanoor(po)
Kanniyakumari district
Tamilnadu 629177
Kanniyakumari
TAMIL NADU
62917
India |
| Phone |
9442399314 |
| Fax |
|
| Email |
drjananikannan777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Priya Rajini |
| Designation |
Associate Professor |
| Affiliation |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine White Memorial Homoeo Medical College and hospital
Attoor,
Veeyanoor(po)
Kanniyakumari district
Tamilnadu 629177
White Memorial Homoeopathic Medical College and Hospital
Attoor,
Veeyanoor(po)
Kanniyakumari district
Tamilnadu 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9442399314 |
| Fax |
|
| Email |
drpriyarm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janani.K |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
White Memorial Homoeopathic Medical College and Hospital
Attoor,
Veeyanoor(po)
Kanniyakumari district
Tamilnadu 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9442399314 |
| Fax |
|
| Email |
drjananikannan777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Practice of Medicine
White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (PO), Kanniyakumari district, Tamilnadu 629177
|
|
|
Primary Sponsor
|
| Name |
White memorial homoeopathic medical College and hospital |
| Address |
White memorial homoeopathic medical College and hospital
Attoor
Veeyanoor (Po)
Kanniyakumari district
Tamilnadu 629177 |
| 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 |
| JANANIK |
White Memorial Homoeopathic Medical College and Hospital |
Department of Practice of Medicine White Memorial Homoeopathic Medical College and Hospital , Attoor, Veeyanoor Kanniyakumari district, Tamilnadu 629177
Kanniyakumari
TAMIL NADU |
9442399314
drjananikannan777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee White memorial homoeopathic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines for the
Experimental Group(Group A) |
15 Patients Under This Group A Will Be Given Homoeopathic Medicines With Rehabilitation.
Individualised Homoeopathic Medicines in Centisemal Potencies will be administered to the Patient in Proper dose, Potency and Repitation of Medicine according to Homoeopathic Principles.All the Individuals in the study are given Medicine with Rehabilitation.Each case will be reviewed after 15 days Interval or as per need in case of emergency and followed up for Maximum of 6 months.Assessment of the case will be done using Stroke Impact Scale tool at the Last. |
| Comparator Agent |
No Placebo For The Control Group
(Group B) |
15 Patients Under This Group B Will not Be Given Homoeopathic Medicines And They Will Be Continuing The Conventional Medicine With Rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed cases of cerebrovascular accident
window period of post stroke patients below 3 months will be excluded. |
|
| ExclusionCriteria |
| Details |
Patients under any other neurologic diseases
patients who were under emergency conditions
window period of post stroke patients below 3 months will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhancing the quality of life in post cerebrovascular accident with homoeopathy |
Intial Visit After after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study follow up and assessment of stroke impact scale will be done |
1 year |
|
|
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 2 |
|
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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drjananikannan777@gmail.com].
- For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· The patient will be categorised into two groups, Group A and Group B. Group A : A sample of 15 diagnosed cases of Post CVA from OPD, IPD and peripheral centers of WMHMC will be included in the study. Group B : A sample of 15 diagnosed cases from Physiotherapy unit previously under conventional treatment of WMHMC will be included in the study. Group A patients are under Homoeopathic medications and Rehabilitation therapy will be given as per the patients conditions. The Group B patients are previously under conventional medicine will be given rehabilitation methods based upon patient’s condition. Follow up will be done monthly once for 6 months for each patient after administration of medicine, recording patient changes and quality of life using a validated questionnaire Stroke impact Scale (Post assessment) will be done at 3-month intervals for both group of patients. Pre and Post treatment analysis will be done using a Predesigned validated questionnaire form Stroke Impact Scale 3.0 for both the groups. |