Homeopathic treatment of paralysis after stroke

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Medical Research Councils muscle strength grading scale (MRC muscle scale)	At baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
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

Locations (1): National Institute Of Homoeopathy
🇮🇳
Kolkata, WEST BENGAL, India
National Institute Of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
Abhijit Dutta
Principal investigator
9641439759
drabhijitdutta1@gmail.com