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Add on efficacy and safety of Myostaal liniment for the reduction of spasticity of the muscles with only Physiotherapy given group.

A prospective, randomized, comparative, parallel, 2- arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for the reduction of spasticity in patients suffering from Hemiplegia.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029850
Enrollment
30
Registered
2020-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G819- Hemiplegia, unspecified

Interventions

Intervention1: Myostaal liniment application and Physiotherapy exercises over affected part of the body: Application of Myostaal liniment once per day and standard physiotherapy exercises for 30 days

Sponsors

Solumiks Herbaceuticals Limited
Lead Sponsor
Superintendent
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Hemant Toshikhane

Parul Institute Of Ayurveda / Parul University

drhemantt@gmail.com9964596478

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026