| CTRI Number |
CTRI/2018/02/011930 [Registered on: 16/02/2018] Trial Registered Prospectively |
| Last Modified On: |
21/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic treatment of post-stroke paralysis |
|
Scientific Title of Study
|
An open observational trial of individualized homeopathic treatment in stroke impairment and disability and validation of the Stroke Impact Scale questionnaire in Bengali language |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1208-5850 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata
Haora
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9831063837 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MHM College Hospital The CHM College Hospital |
| Address |
Midnapore Homeopathic Medical College and Hospital, Govt. of West Bengal; PO Midnapore, Paschim Medinipur 721101, West Bengal, India; The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal; 265-266, APC Road, Kolkata 700009, West Bengal, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kaushik Deb Das |
Midnapore Homoeopathic Medical College and Hospital |
OPD 5, every Tuesday, PO Midnapore, Paschim Medinipur
Medinipur
WEST BENGAL |
9932298682
drkaushikddas75@gmail.com |
| Himangsu Hait |
The Calcutta Homoeopathic Medical College and Hospital |
OPD 12, every Tuesday, 265-266, A. P. C. Road, Kolkata 700009
Kolkata
WEST BENGAL |
9433565680
haitdrhimangsu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Midnapore Homoeopathic Medical College and Hospital |
Approved |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post-stroke impairment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal or 50 millesimal potencies |
In centesimal potencies, each dose consists of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 90% v/v ethanol, 10 doses 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. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 3 months |
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. Both sexes
3. Symptomatic for at least last 3 months
4. Standard or any other therapy for stroke impairment, if ongoing, discontinued for at least 1 month |
|
| ExclusionCriteria |
| Details |
1. Patients who are too sick for consultation
2. Unable to read patient information sheets, and not giving consent to take part
3. Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life
4. Any major surgery within last 6 months
5. Currently receiving homeopathic treatment for chronic condition(s)
6. Pregnant women and lactating mothers
7. Self-reported immune-compromised state
8. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 5 point muscle strength grading scale (Oxford scale) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of the Stroke Impact Scale version 3.0 |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
19/02/2018 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stroke is the third most common cause of death and the second most common cause of functional disability in the world, according to the World Health Organization data. The disease results in a high mortality rate and a high degree of functional disability. In survivors, varying degrees of functional impairment, from light (35.8%), to medium (33.3%) and severe (30.9%), were registered. Physical disability, to a greater or lesser extent, may cause damage to the working ability and activities of daily living. The optimal rehabilitation included medical, cognitive, social and vocational processes. Complementary and Alternative Medicine (CAM), including homeopathy is commonly used by almost 1/3rd patients with stroke throughout the world, particularly in Asia and India, because of limb weakness, dysphagia, dyslipidemia, hypertension, hemorrhagic stroke, severe stroke, and unsatisfactory outcome from standard treatment alone; but well-conducted trials were warranted to better define the role of alternative therapies. Some homeopathically prepared remedies show promise for reducing infarct size and associated impairments. Despite many promising leads, the evidence does not favor recommendation of most of these treatments from a public health policy perspective. A great deal of systematic research effort lies ahead before it would meet mainstream medical standards for introduction into routine treatment regimens. Homeopathic research database on treatment of stroke or post-stroke complications has remained compromised. A comprehensive search into electronic databases revealed only 4 relevant papers. Also the Stroke Impact Scale 2.0 and 3.0 versions (SIS) in assessment of patient-rated outcome remained under-utilized in homeopathy; and the question whether individualized homeopathy can produce any significant treatment effect in post-stroke complications remained unanswered. In this project, first we intend to develop translated Bengali version of the Stroke Impact Scale 3.0 through standardized forward-backward translation method, and to validate it on 120 patients in the outpatients of two institutions – namely, Midnapore Homoeopathic Medical College and Hospital and The Calcutta Homoeopathic Medical College and Hospital. Following that, we intend to use it as an outcome measure in an open observation trial testing usefulness of individualized homeopathic treatment in post-stroke impairment. Inclusion criteria are age 18 years and above, both sexes, symptomatic for at least last 3 months, and standard or other CAM therapy for post-stroke impairment, if ongoing, discontinued for at least 1 month. Exclusion criteria are the patients who are too sick for consultation, unable to read patient information sheets, and not giving consent to take part, diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life, currently receiving homeopathic treatment for chronic condition(s), pregnant and lactating women, self-reported immune-compromised state, and substance abuse and/or dependence. Patients suffering from post-stroke impairment will undergo detailed screening as per the mentioned inclusion and exclusion criteria. The eligible participants will be interviewed to collect data for running psychometric validation statistics using SPSS and AMOS, version 24. Following validation, eligible patients will be recruited in the trial and will be treated with individualized homeopathic medicines for 3 months. Outcomes in terms of 5 point muscle strength grading scale (Oxford scale) and translated Bengali version of the Stroke Impact Scale 3.0 will be measured at baseline, and after 3 months. Intention-to-treat (ITT) sample will be analyzed in the end. Effect sizes (Cohen’s d) will be reported 3 months after treatment. P values less than 0.05 two-tailed will be considered as statistically significant. The results will be published in peer-reviewed indexed journals. |