| CTRI Number |
CTRI/2024/08/072795 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness Of Homoeopathic medicine in the treatment of Post-stroke hemiplegia |
|
Scientific Title of Study
|
Effectiveness Of Individualised Homoeopathic Medicine As An Adjuvant In The Management Of Post-Stroke Hemiplegia: A Single Arm Prospective Interventional Study |
| 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 Daffinisa K Lyngdoh |
| Designation |
PG Scholar, Dept. Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9366681729 |
| Fax |
- |
| Email |
lyngdohdaffinisa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SGS Chakravarthy |
| Designation |
Professor, Dept. Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
- |
| Email |
sgschakravarthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SGS Chakravarthy |
| Designation |
Professor, Dept. Of Practice Of Medicine |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Department of Practice of Medicine-
National Homoeopathy Research Institute In Mental Health,
Sachivothamapuram P.O Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
- |
| Email |
sgschakravarthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health, Kurichy Sachivothamapuram P.O, Kottayam- 686532 Kerala, India |
|
|
Primary Sponsor
|
| Name |
Dr Daffinisa K Lyngdoh |
| Address |
National Homoeopathy Research Institute In Mental Health, Sachivothamapuram (P.O), Kurichy
Kottayam, Kerala-686532 India |
| 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 Daffinisa K Lyngdoh |
National Homoeopathy Research Institute In Mental Health |
OPD,IPD,Camps and Peripheral units, Dept Of Practice Of Medicine, Sachivothamapuram (P.O) Kurichy Kottayam, Kerala
Kottayam
KERALA |
9366681729
lyngdohdaffinisa@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: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
After enrolment Individualized Homoeopathic medicines of any potency starting from 6C to 50 M (both centesimal and millesimal) as per the need of the case will be prescribed adjuvant to standard conventional care along with standard physiotherapy sessions for the treatment of post-stroke hemiplegia for time period of 18 months.( Enrolment period of 8 months and follow up period of 10 months) |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Hemiplegic patients having a history of stroke/CVA.
2.MRI or CT scan-based evidence of stroke.
|
|
| ExclusionCriteria |
| Details |
1.Hemiplegia secondary to trauma or tumour.
2.Patients with known meningitis, encephalitis.
3.Patients with known cerebral metastasis, rapidly growing malignant neoplasms, multiple sclerosis, and slow-growing neoplasms ruled out by MRI.
4.Patients with malignant hypertension, uncontrolled hyperlipidaemia and uncontrolled diabetes.
5.Patients with severe manifestations of stroke (NIHSS score more than 20).
6.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measurement will be done by assessing reduction in the NIHSS score after administration of individualised homoeopathic medicine. |
Baseline, 5th month and 10th month of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
02/09/2024 |
| 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
|
This study is undertaken to determine the effectiveness of individualised homoeopathic medicine in the symptomatic management of post-stroke hemiplegia as assessed by using the NIHSS scores. It will be conducted in National Homoeopathy Research Institute in Mental Health, Kurichy Kottayam. The primary outcome measure will be evaluated by the reduction in the score of NIHSS after administration of individualised homeopathic medicine at baseline, 5th and 10th month of the study.The study duration is 18 months with enrolment period of 8 months and follow up period of 10 months. |