Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Feb;42(2):249-269.
doi: 10.1007/s11095-025-03818-2. Epub 2025 Jan 28.

Efficacy and Safety of Boswellia serrata and Apium graveolens L. Extract Against Knee Osteoarthritis and Cartilage Degeneration: A Randomized, Double-blind, Multicenter, Placebo-Controlled Clinical Trial

Narendra Vaidya  1 , Ramshyam Agarwal  1 , D G Dipankar  2 , Hrishikesh Patkar  3 , Gayatri Ganu  4 , Dheeraj Nagore  4 , Chhaya Godse  5   6 , Anirudh Mehta  5   6 , Dilip Mehta  5   6 , Sujit Nair  7   8
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Boswellia serrata and Apium graveolens L. Extract Against Knee Osteoarthritis and Cartilage Degeneration: A Randomized, Double-blind, Multicenter, Placebo-Controlled Clinical Trial

Narendra Vaidya et al. Pharm Res. 2025 Feb.

Abstract

Background: Osteoarthritis is the prevailing form of inflammatory condition in joints of adults and the aging population, leading to long-term disability and chronic pain. Current therapeutic options have variable therapeutic efficacy and/or several side effects.

Methods: A randomized, placebo-controlled, double-blind clinical trial was conducted in 62 participants using a nutraceutical [standardized Boswellia serrata Roxb. gum resin (300 mg) and Apium graveolens L. seed extract (250 mg)], to determine its safety and efficacy for supporting cartilage health and reduction in knee osteoarthritis symptoms. All participants were assessed for physical function and pain with the help of WOMAC, VAS, Physicians' Global Assessment for the six-minute walk test/pain. Knee X-ray, KOOS questionnaire score, and FACIT-F score were assessed. Additionally, inflammatory, cartilage degeneration and regeneration biomarkers in serum and urine were evaluated at baseline and after 90 days of treatment.

Results: Oral administration of the nutraceutical resulted in prolonged symptomatic relief with reduced pain, stiffness, and swelling. Inflammatory (serum IL-7, IL-1, IL-6, hs-CRP, TNF-α, ESR) and cartilage degeneration biomarkers (serum CTX-II, COMP, MMP-3 and urinary CTX-II) were decreased in the nutraceutical group compared to baseline and placebo. Furthermore, serum N-propeptide of collagen IIA (PIIANP) and procollagen-type-C propeptide (PIICP) levels were increased in the nutraceutical group, suggesting collagen synthesis contributing to cartilage regeneration. At given doses for 90 days, there were no adverse effects based on the clinical examination, biochemical, hematological, and ECG analysis.

Conclusions: Taken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively.

Keywords: cartilage support; clinical trial; inflammation; knee osteoarthritis; nutraceutical.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of Interest: RestorCel™ is marketed by Phytoveda Pvt. Ltd., Mumbai, India which funded this study. CG, AM, DM and SN are employees of Phytoveda Pvt. Ltd., Mumbai, India and Viridis Biopharma Pvt. Ltd., Mumbai, India. However, these authors had no role in the conduct of the trial or analysis of results. The clinical trial was conducted by an external Contract Research Organisation (CRO), MPREX Healthcare Pvt. Ltd., Pune, India, who analyzed the results themselves along with the clinicians conducting the study in this multicentric trial (NV, RA, DGD, HP, GG, DN).

Figures

Fig. 1
Fig. 1
Study Protocol: Patients were instructed to consume the designated capsule (nutraceutical or placebo) twice a day, 30 min after breakfast and dinner for 90 days.
Fig. 2
Fig. 2
Reduction in symptoms and improved physical function by the nutraceutical by 90 days of treatment.
Fig. 3
Fig. 3
Effect of the nutraceutical on various symptoms due to osteoarthritis compared to placebo.
Fig. 4
Fig. 4
Representative radiological X-ray images of Participant #0104's Knee Before (A) and After (B) nutraceutical treatment.
Fig. 5
Fig. 5
Assessment of changes in fatigue severity score between groups.
Fig. 6
Fig. 6
Effect of the nutraceutical on inflammatory markers.
Fig. 7
Fig. 7
Effect of the nutraceutical on the degeneration of cartilage.
Fig. 8
Fig. 8
Effect of the nutraceutical on the regeneration of cartilage.
See this image and copyright information in PMC

References

    1. Castrogiovanni P, Trovato FM, Loreto C, Nsir H, Szychlinska MA, Musumeci G. Nutraceutical supplements in the management and prevention of osteoarthritis. Int J Mol Sci. 2016;17(12):2042. - PMC - PubMed
    1. Colletti A, Cicero AFG. Nutraceutical approach to chronic osteoarthritis: from molecular research to clinical evidence. Int J Mol Sci. 2021;22(23):12920. - PMC - PubMed
    1. Yokota S, Ishizu H, Miyazaki T, Takahashi D, Iwasaki N, Shimizu T. Osteoporosis, osteoarthritis, and subchondral insufficiency fracture: recent insights. Biomedicines. 2024;12(4):843. - PMC - PubMed
    1. Steinmetz JD, Culbreth GT, Haile LM, Rafferty Q, Lo J, Fukutaki KG, et al. Global, regional, and national burden of osteoarthritis, 1990–2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5(9):e508–22. - PMC - PubMed
    1. Ohio CV PharmD, BCPS Assistant Professor of Pharmacy Practice University of Findlay Findlay, Ohio Laura A Perry, PharmD, BCPS Professor of Pharmacy Practice/ University of Findlay Findlay, Ohio Amanda Crase, PharmD Candidate 2024 University of Findlay Findlay, Ohio Anthony Swierz, PharmD Candidate 2024 University of Findlay Findlay, Ohio Sydney Wenzinger, PharmD Candidate 2024 University of Findlay Findlay. Guiding Osteoarthritis Management. [cited 2024 Aug 17]. Available from: https://www.uspharmacist.com/article/guiding-osteoarthritis-management.

Publication types

LinkOut - more resources