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CTRI Number  CTRI/2024/12/077756 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homeopathic medicines for Parkinsons disease in thhe elderly 
Scientific Title of Study   Role of individualized homoeopathic medicines in the treatment of Parkinsons disease in elderly: A single-arm, quasi-experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1316-1198  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Md Yasin Biswas 
Designation  Postgraduate Trainee 
Affiliation  D. N. DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicne) and 1 (Medicne), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  8348732746  
Fax    
Email  mdyasin10700@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mohan Giri 
Designation  Professor and Head 
Affiliation  D N de Homoeopathic Medical College and Hospital 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicne) and 1 (Medicne), 12, Gobinda Khatick Road Kolkata 700046

Kolkata
WEST BENGAL
700046
India 
Phone  9433904265  
Fax    
Email  giri.drmohan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohan Giri 
Designation  Professor and Head 
Affiliation  D N de Homoeopathic Medical College and Hospital 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicne) and 1 (Medicne), 12, Gobinda Khatick Road Kolkata 700046

Kolkata
WEST BENGAL
700046
India 
Phone  9433904265  
Fax    
Email  giri.drmohan@gmail.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road Kolkata 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Yasin Biswas  D N De Homoeopathic Medical College and Hospital  Dept of Practice of Medicine OPD room number PG5 and 1 (Medicine) 12 Gobinda Khatick Road
Kolkata
WEST BENGAL 		 8348732746

mdyasin10700@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homeopathic medicines  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on a clean tongue on an empty stomach; doses and repetition depend upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking, or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, and miasmatic expressions, with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Route of administration per oral. Duration of therapy: 3 months 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from PD with symptoms the presence of Bradykinesia and at least one other feature of parkinsonism viz. rigidity, tremors, or impaired balance. (ICD 10 code G20)
2. Elderly people of 60 to 75 years.
3. Patients of both sex 
 
ExclusionCriteria 
Details  1. Denying written informed consent voluntarily.
2. Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, and mentally incompetent people.
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled diabetes or life-threatening illness affecting the quality of life or any organ failure.
4. Patient under tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence (TAPS tool).
5. Self-reported immune-compromised state.
Already undergoing homeopathic treatment for chronic disease or any other mode of treatment for PD within the last 6 months.
6. simultaneous participation in any other clinical trials.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Scales for Outcomes in parkinsons Disease Motor Function (SCOPA-Motor)  Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Parkinsons Disease Quality of Life Questionnaire (PDQ-8)  Baseline, every month, up to 3 months 
Measure Yourself Medical Outcome Profile, version 2 (MYMOP-2) questionnaire  Baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   N/A 
Date of First Enrollment (India)   16/12/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mdyasin10700@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Parkinson’s disease (PD) is a complex, progressive, chronic neurodegenerative disorder of elderly people described by English physician James Parkinson in 1817. Reflecting the unique symptoms of his patients, the name Parkinson’s disease “ was adopted and used by the public ever since approximately 10 million people. The primary basis for the clinical diagnosis of PD is motor characteristics like cogwheel rigidity a slowly progressing asymmetric resting tremor inflexibility, and bradykinesia, even though nonmotor highlights which incorporate anosmia, depression, insomnia, cognitive impairment, dementia, sensory disturbances, and rapid eye movement sleep behaviour disorder are all possible conditions. Numerous medicines and surgical resources are not available, accessible, or reasonable all over especially in low and middle-income countries. However, the effectiveness of the treatment is still controversial. Evidence of homoeopathic experience in the treatment of the symptoms of PD, i.e. Bradykinesia, rigidity, and tremors are already clearly documented in homoeopathic literature in the form of Repertoires and Materia Medica. A single-arm quasi-experimental study will be conducted at D N De Homoeopathic Medical College and Hospotal on 34 patients with parkinson’s disease and all will be treated with individualized homeopathic medicines for 3 months. The primary outcome is SCOPA-motor; the secondary outcomes comprise of PDQ-8 and MYMOP-2; all measured at baseline and every month, up to 3 months. Changes will be determined using inferential statistics. Results will be published in scientific journals. 
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