CTRI/2020/12/029850已完成2 期
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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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