Topical Product Containing Java Long Pepper Extract on Muscle Pain: A Randomized Controlled Trials

Phase 2

Completed

• Conditions: Muscle pain; Long pepper extract; Piper retrofractum Vahl; muscle pain; topical product; piperine; Deplee

• Registration Number: TCTR20230221007
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

In conclusion, the 2% long pepper extract gel containing 0.29% piperine was safe and effective for relief acute muscle pain. Future study with larger sample size should be conducted to assess the clinical effect of long pepper extract product containing piperine as the active compound, in comparison to current topical products for muscle pain or other pain conditions such as neuropathic pain or arthritis.

Detailed Description

Not available

Study Timeline

• Study Completion: 2008-06-27
• Study Start: 2023-02-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Male or female with aged 18 years or older who had muscle pain confirmed by physician.

Exclusion Criteria

1. Patients who experienced any clinically significant or unstable medical conditions.
2. Patients who were pregnant and childbearing.
3. Patients with a muscle pain due to systemic infection or patients with skin conditions such as wound or infection on pain area.
4. Patients who had known allergies to piperine, long pepper extract or other ingredients of products.
5. Patients who used oral or topical medicines for pain relief such as NSAIDS, methyl salicylate, steroids, opioids, tricyclic antidepressant, anticonvulsant within 1 week before starting date.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of improving present pain intensity (PPI) end of study Improvement in PPI was defined as no pain or decrease of present pain intensity (PPI) measured using Th-SFMPQ by at least 2 levels from baseline

Secondary Outcome Measures

Name	Time	Method
proportion of treatment success in VAS end of study Treatment success defined as at least 80% reduction of visual analogue scale (VAS) at the end of the study compared with the baseline,improvement in verbal rating scale (VRS) in pain relief end of study VAS improvement defined as no pain or pain relief by at least 2 levels at the end of study compared with baseline.,average and percentage of VAS reduction end of study VAS score measured using the Thai-McGill questionnaire,average of pain scores on affective, sensory, and total score reduction end of study average reduction of pain score using the Thai-McGill questionnaire,patient satisfaction end of study average score,Number of paracetamols used end of the study Average number of paracetamols,Adverse event end of study number of adverse event