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
|
|
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
|
|
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. |