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CTRI Number  CTRI/2018/10/016196 [Registered on: 30/10/2018] Trial Registered Prospectively
Last Modified On: 22/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of paralysis after stroke 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Medicines in the Treatment of Post-Stroke Hemiparesis: An Open, Randomized, Placebo-Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1221-7664  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhijit Dutta 
Designation  Postgraduate Trainee 
Affiliation  National Instittute of Homoeopathy 
Address  OPD room no. 4 and 5, Department of Organon of Medicine and Homoeopathic Philosophy, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9641439759  
Fax    
Email  drabhijitdutta1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhas Singh 
Designation  Associate Professor and Head 
Affiliation  National Institute of Homoeopathy 
Address  Department of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subhas Singh 
Designation  Associate Professor and Head 
Affiliation  National Institute of Homoeopathy 
Address  Department of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy; Block GE, Sector III, Salt Lake, Kolkata 700106 
 
Primary Sponsor  
Name  National Institute Of Homoeopathy 
Address  Block GE, Sector III, Salt Lake, Kolkata 700106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abhijit Dutta  National Institute Of Homoeopathy  Department of Organon of Medicine and Homoeopathic Philosophy; OPD room no. 5 and 7, Block GE, Sector III, Salt Lake, Kolkata 700106
Kolkata
WEST BENGAL 
9641439759

drabhijitdutta1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homeopathic medicines in centesimal and 50 millesimal potencies  Intervention is planned as administering indicated homoeopathic medicines in centesimal or 50 millesimal potencies. In case of centesimal potency, each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. All medicines will be procured from a Good Manufacturing Practice (GMP) certified firm. Along with medicines, the intervention arm will receive standard physiotherapy. Duration of therapy: 3 months. 
Comparator Agent  Placebo, indistinguishable from verum  This arm, along with standard physiotherapy, will receive placebo, indistinguishable from the verum. Placebo each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach. In 50 millesimal scale, a single non-medicated cane sugar globule of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Dosage and repetition will be depending upon the individual requirement of the cases. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Cases suffering from Post-stroke Hemiparesis consistently for more than 3 months
2. Both male and female patients
3. Age 35- 70 years
4. Ability to read English and/or Bengali
5. Capability and willingness to give informed consent and to comply with the study protocol 
 
ExclusionCriteria 
Details  1. Patients not willing to participate in the study and denying consent
2. Hemiparesis due to causes other than stroke
3. Patients with psychiatric disorders
4. Pregnant or lactating women
5. Self-reported immune-compromised state
6. Substance abuse and/or dependence
7. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
8. Cases already undergoing homeopathic treatment for any chronic disease within eight weeks prior to enrolment 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Medical Research Councils muscle strength grading scale (MRC muscle scale)  At baseline and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Stroke Impact Scale (SIS) version 2.0  At baseline and after 3 months 
Modified Ashworth Scale (MAS) measuring muscle spasticity  At baseline and after 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet, to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In developed countries, stroke is the most frequent cause of disability among the adults. Due to better medical care of present day scenario, death rate due to stroke has been decreased, but alongside disability due to stroke increased. Unfortunately, the majority of patients with stroke experience incomplete recovery of motor deficits despite intensive rehabilitation, with up to 60% having impaired manual dexterity 6 months following the stroke. Hemiparesis is a serious motor impairment following stroke and affecting around 65% of stroke patients. Currently, the stroke incidence in India is much higher than western industrialized countries. Studies with homeopathic medicines show significant effect in stroke patient. In this prospective, open, randomised, placebo controlled pilot trial at National Institute of Homoeopathy, 60 patients suffering from post-stroke hemiparesis will be randomised in 1:1 ratio into either individualised homeopathic medicines or placebo in the mutual context of standard physiotherapeutic measures. Medical Research Council muscle strength grading scale (MRC muscle scale) will be used as the primary outcome measure and Stroke Impact Scale (SIS) and Modified Ashworth Scale (MAS) as the secondary outcome measures; measured at baseline, and after 3 months. At the end of 3 months, comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.

 
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