by Chronic pain is a debilitating condition affecting millions worldwide, often challenging to manage with conventional treatments. Kratom, a botanical substance derived from the Mitragyna speciosa tree, has gained attention for its potential analgesic properties. This clinical trial aims to assess the efficacy of the best kratom brands in managing chronic pain compared to placebo among adult participants.
Study Design:
Study Type: Randomized, double-blind, placebo-controlled trial.
Participants: Adult individuals aged 18-65 years with chronic pain (>3 months duration) not adequately controlled by conventional treatments.
Intervention: Participants randomized to receive either kratom pills or placebo for a duration of 8 weeks.
Dosage: Kratom pills containing standardized doses of kratom extract (X mg) administered orally three times daily. Placebo pills matched in appearance and dosage schedule.
Outcome Measures:
- Primary Outcome: Change in pain intensity measured using a visual analog scale (VAS) from baseline to week 8.
- Secondary Outcomes: Changes in pain interference, quality of life, mood, and adverse events assessed using validated questionnaires and scales.
Study Procedures:
- Screening and Enrollment: Participants screened for eligibility based on inclusion/exclusion criteria and provided informed consent.
- Baseline Assessment: Demographic and clinical data collected, baseline pain intensity assessed using VAS.
- Randomization: Participants randomized in a 1:1 ratio to kratom or placebo group using computer-generated randomization.
- Intervention: Participants instructed to take assigned pills as per schedule and record daily pain scores and medication adherence.
- Follow-up Visits: Participants assessed at weeks 2, 4, 6, and 8 for outcome measures, adverse events, and medication compliance.
- Data Analysis: Intent-to-treat analysis performed to compare outcomes between groups using appropriate statistical tests (e.g., t-tests, ANOVA) with adjustments for potential confounders.
Expected Outcomes:
We hypothesize that participants receiving kratom pills will experience greater reductions in pain intensity compared to those receiving placebo.
Secondary outcomes may reveal improvements in pain interference, quality of life, and mood among kratom recipients.
Safety profile of kratom pills assessed based on incidence and severity of adverse events.
Conclusion:
This clinical trial aims to provide robust evidence regarding the efficacy and safety of the best kratom capsules in managing chronic pain. Findings from this study have the potential to inform clinical practice and guide treatment decisions for individuals with chronic pain, addressing an unmet need in pain management.