| CTRI Number |
CTRI/2023/11/059894 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effects of Homoeopathic Medicines in patients with Parkinsons Disease. |
|
Scientific Title of Study
|
An Exploratory Clinical Study to find out the Effectiveness of Homoeopathic Medicines in the management of Parkinsons Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Hosmath |
| Designation |
PG Scholar, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
PG Scholar, Department of Practice of medicine, National Homoeopathy Research Institute in Mental Health, Kurichy Sachivothamapuram P O, Kottayam, Kerala 686532
Kottayam
KERALA
686532
India |
| Phone |
6361878523 |
| Fax |
|
| Email |
hosmathaishwarya57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SGSChakravarthy |
| Designation |
Professor, Department of Practice of medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
Professor, Department of practice of medicine, National Homoeopathy Research Institute in Mental Health, Kurichy Sachivothamapuram P O, Kottayam, Kerala 686532
Kottayam
KERALA
686532
India |
| Phone |
9908019739 |
| Fax |
|
| Email |
sgschakravarthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SGSChakravarthy |
| Designation |
Professor, Department of Practice of medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
| Address |
Professor, Department of Practice of medicine, National Homoeopathy Research Institute in Mental Health, Kurichy Sachivothamapuram P O, Kottayam, Kerala 686532
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, Kerala 686532 |
|
|
Primary Sponsor
|
| Name |
Dr. Aishwarya Hosmath |
| Address |
National Homoeopathy Research Institute in Mental Health, Kurichy Sachivothamapuram P O, Kottayam, Kerala 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 Aishwarya Hosmath |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
OPD/Peripheral centers of Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy Sachivothamapuram P O, Kottayam, Kerala 686532
Kottayam
KERALA |
6361878523
hosmathaishwarya57@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, Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
The administration of homeopathic medicines will be based on a comprehensive assessment of the patients case, utilizing repertorization with the relevant repertory and referencing the Homeopathic materia medica. Dosages will be tailored to the individuals susceptibility, with potencies ranging from 6C, 12C, 30C, 200C, 1M, 10M, and LM potencies, respectively. The prescribed frequency of medication will be monthly over a 10-month period, utilizing pill size 30. The oral route will be employed for the administration of the medication, adhering to professional standards. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Modified Hoehn and Yahr scale upto stage 4 |
|
| ExclusionCriteria |
| Details |
1. Individuals diagnosed with other significant Neurological disorders such as multiplesclerosis,
Motor neuron disorders, and Malignancies.
2.Uncontrolled Diabetes Mellitus and Hypertension, and any severe life-threatening medical
illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cases will be assessed using the MDS-sponsored Revision of the Unified Parkinson’s Disease
Rating Scale (MDS-UPDRS) for the Parkinson’s disease. |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 |
|
Date of First Enrollment (India)
|
26/11/2023 |
| 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 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
|
This study is an Exploratory Clinical study to find out the effectiveness of Homeopathic medicines on the symptoms of Parkinson’s Disease. In this study MDS Sponsered Unified Parkinson’s Disease rating scale (MDS-UPDRS) will be used to assess the changes in the sympotoms of Parkinson’s Disease. This study will have 8 months enrollement period with 10 months of follow up period. The Outcome will be measured using MDS-UPDRS. |