Efficacy and safety of extracted Prasaplai for relieving acute muscle strai
- Conditions
- Patients with muscle strain (ICD10 : M5400 -M5409,M6260 -M6269,M7910 -M7919 and M7960 -M7969) who have VAS pain score > 3Muscle strainPrasaplaiAcute pain
- Registration Number
- TCTR20160126001
- Lead Sponsor
- Pharmaceutical science, Mahasarakham universitty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 370
1.Male or female with aged 20 - 45 years
2. Patient with muscle strain (ICD10 : M5400 - M5409, M6260 - M6269, M7910 - M7919 and M7960 - M7969) who have VAS pain score > 3
1.Patients with muscle strain cause by infection such as common cold, pyelonephritis.
2. Patients with chronic diseases such as CKD, Cirrhosis or Liver diseases, DM, HT, CVD.
3.Patients with CVD who have to treat by aspirin.
4. Patients who used other drugs such as tramadol, muscle relaxants, corticosteroid, non-steroid anti-inflammatory (NSAIDs) and anti-depressants except paracetamol.
5. Patients who used topical drug including Corticosteroid, non-steroid anti-inflammatory and analgesic prodrugs
6. Patients who are allergic to Prasaplai, Plai and other composition
7. Patients who are allergic toDiclofenac or other NSAIDs or other composition
8. Pregnancy and Lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Present pain intensity (PPI) 7 days Short- form McGill Pain Questionnaire, Thai version
- Secondary Outcome Measures
Name Time Method efficacy (VAS, affective score and sensory score) and safety 7 days Short- form McGill Pain Questionnaire (Thai version), ADRs, AEs,proportion of Paracetamol used, satisfaction, Pain relief score, treatment success 7 days Short- form McGill Pain Questionnaire (Thai version)