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 scores; liver, kidney and blood safety tests
What the authors reported
All four inflammatory markers fell from baseline in the add-on group (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 also improved from baseline; the standard-therapy group showed no significant change. Safety blood tests stayed in normal range, with 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.