Add on efficacy and safety of Myostaal liniment for the reduction of spasticity of the muscles with only Physiotherapy given group.
- Conditions
- Health Condition 1: G819- Hemiplegia, unspecified
- Registration Number
- CTRI/2020/12/029850
- Lead Sponsor
- Solumiks Herbaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
1.Patient of either sex in the age group of 30-70 years.
2.Diagnosed case of Hemiplegia who is stable after onset up to 01 year.
3.Patients willing to give written informed consent.
4.Patients willing to follow up.
Subject Exclusion Criteria:
1. Comatose patients.
2. Patient on : (a) oral multi-vitamin therapy within the previous 07 days, or (b) intramuscular multiviatmins within 07 days, or (c) Oral protein suppliments which claims to enhance the muscle power, or (d) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
(e) Patients on NSAIDS use will be excluded
3. Patient who has undergone cranial surgery or who is planning to undergo surgery in next 1 month will be excluded from the study.
4. Patients suffering from cerebral and cerebellar atrophy due to infectious diseases like encephalitis.
5. Patient with space occupying lesions and known case of Epilepsy.
6. Patients with auto-immune disease, uncontrolled hypertension,
7. Diabetes mellitus requiring insulin injections, chronic severe respiratory disease and severe active infectious disease requiring hospitalization.
8. Patient with history of any other systemic illness, life threatening cardiovascular and other progressive neurological diseases.
9. Patient with history of severe allergy or anaphylactic reaction.
10. Patient participating in another investigational drug trial in the previous 30 days.
11. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
12. History of HIV, Hepatitis B or any immune deficient conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in muscle strength assessed on basis of Tardieu Scale ? to assess the spasticity, Goniometer to assess the Range of movement of affected shoulder joint, elbow joint and wrist jointTimepoint: at baseline, 15 days, at the end of 30 days
- Secondary Outcome Measures
Name Time Method Adverse events recordingTimepoint: at baseline, 15 days, at the end of 30 days;Patient’s Global safety assessment scoreTimepoint: at baseline, 15 days, 30 days