Efficacy and safety of extracted Prasaplai for relieving acute muscle strain

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20160126001

Enrollment

370

Registered

2016-01-26

Start date

2016-02-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients with muscle strain (ICD10 : M5400 &#45

Interventions

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

Experimental Drug,Active Comparator Drug

Prasaplai extracted and placebo of diclofenac, Diclofenac and placebo of Prasaplai

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Present pain intensity (PPI) 7 days Short- form McGill Pain Questionnaire, Thai version	—

Secondary

Measure	Time frame
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)	—

Countries

Thai

Contacts

Public ContactMatoorada Wisai

Mahasarakham University

doong06@hotmail.com0817688752

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026