Homeopathic treatment of post-stroke paralysis
- Conditions
- Post-stroke impairment
- Registration Number
- CTRI/2018/02/011930
- Lead Sponsor
- MHM College Hospital The CHM College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
- Substance abuse and/or dependence.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5 point muscle strength grading scale (Oxford scale) 3 months
- Secondary Outcome Measures
Name Time Method Translated Bengali version of the Stroke Impact Scale version 3.0 3 months
Trial Locations
- Locations (2)
Midnapore Homoeopathic Medical College and Hospital
🇮🇳Medinipur, WEST BENGAL, India
The Calcutta Homoeopathic Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Midnapore Homoeopathic Medical College and Hospital🇮🇳Medinipur, WEST BENGAL, IndiaKaushik Deb DasPrincipal investigator9932298682drkaushikddas75@gmail.com