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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20160126001 |
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Date of registration:
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26/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of extracted Prasaplai for relieving acute muscle strain
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Scientific title:
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Efficacy and safety of extracted Prasaplai for relieving acute muscle strain |
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Date of first enrolment:
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22/02/2016 |
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Target sample size:
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370 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20160126001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Thai
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Contacts
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Name:
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Matoorada
Wisai |
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Address:
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693 M.1 T.palan
44110
Mahasarakham
Thailand |
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Telephone:
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0817688752 |
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Email:
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doong06@hotmail.com |
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Affiliation:
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Mahasarakham University |
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Name:
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Matoorada
Wisai |
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Address:
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693 M.1 T.palan
44110
Mahasarakham
Thailand |
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Telephone:
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0817688752 |
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Email:
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doong06@hotmail.com |
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Affiliation:
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Mahasarakham University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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 to Diclofenac or other NSAIDs or other composition
8. Pregnancy and Lactation
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Muscle strain
Prasaplai
Acute pain
Diclofenac
VAS
Pain score
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Patients with muscle strain (ICD10 : M5400 - M5409, M6260 - M6269, M7910 - M7919 and M7960 - M7969) who have VAS pain score > 3
Muscle strain
Prasaplai
Acute pain
Diclofenac
VAS
Pain score
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Intervention(s)
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Experimental Drug,Active Comparator Drug
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Prasaplai extracted and placebo of diclofenac, Diclofenac and placebo of Prasaplai
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Prasaplai extracted capsule 200 mg/cap 2 X 3 ac for 7 days
placebo of Diclofenac 25 mg/tab 1 X 3 pc for 7 days,Diclofenac sodium 25 mg/tab 1 X 3 pc for 7 days
placebo of Prasaplai 200 mg/cap 2 X 3 ac for 7 days
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Primary Outcome(s)
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Present pain intensity (PPI) 7 days Short- form McGill Pain Questionnaire, Thai version
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Pharmaceutical science, Mahasarakham universitty
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
research@msu.ac.th
Research ethics committy
research@msu.ac.th
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Results
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Results available:
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Date Posted:
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Date Completed:
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07/03/2016 |
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URL:
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