A randomized interventional clinical trial assessing the safety and effectiveness of PeaNoc XL tablets in managing joint pain and inflammation in arthritis patients
Open-label, no control groupHumansWith astaxanthin
This study tested palmitoylethanolamide together with astaxanthin. Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.
- Design
- Open-label, no control group
- Subjects
- 72 adults (18 to 60) with arthritis and DAS28 of 3.2 or more, randomised 36 to standard therapy and 36 to standard therapy plus the tablet; 34 and 35 analysed. Single centre in Tamil Nadu, India
- Dose used in the study
- Two tablets once daily after food, each containing PEA 400 mg and astaxanthin 1 mg (PeaNoc XL, Apex Laboratories), added to standard therapy
- Duration
- 12 weeks
- What was measured
- TNF-alpha, IL-1 beta, IL-6 and CRP by ELISA; WOMAC pain, stiffness and function; liver, kidney and blood safety tests
What the authors reported
In the add-on group, all four inflammatory markers fell from baseline (TNF-alpha p < 0.01, IL-1 beta p < 0.001, IL-6 p < 0.01, CRP p < 0.01), and WOMAC pain, stiffness and function improved from baseline. The standard-therapy group did not change significantly. Safety blood tests stayed in normal range; no serious adverse effects.
Limits of this study
Open label, no placebo. The results reported are changes from baseline within each group, not a direct between-group comparison. 'Arthritis' is not defined by type. The methods section describes a 30-per-group pilot and a nine-month duration that do not match the 72-patient, 12-week results. Funded by Apex Laboratories, which makes the tablet; several authors are its executives. Registered CTRI/2022/10/046693.
Source
doi:10.12688/f1000research.138477.1
Entry checked against the full text (open access), supplied by Devlin on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.