A pilot, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee.

Phytotherapy research : PTR. 2019;33(5):1457-1468

Plain language summary

Osteoarthritis (OA) is an age-related, degenerative joint disorder which affects many people worldwide. It causes pain, most frequently in the large joints such as knee and hips and is characterised by pain, decreased mobility and negative effects on the quality of life. This randomised, double-blind placebo controlled trial of 48 adults between the age of 35 and 75, aimed to evaluate the safety and efficacy of Boswellia serrata extract on newly diagnosed or untreated patients with OA of the knee. 340mg of Boswellia serrata extract was administered daily in 2 doses to the treatment group for 120 days. Outcome measures were WOMAC scores on pain, stiffness and physical function; a 6 min walk test assessing distance; physician assessment of range of motion, strength, stability and tenderness; x-ray images of joint space and growths; and hs-CRP, a blood marker of inflammation. The researchers found that the treatment group significantly improved, with reduced pain and stiffness compared to placebo. X-ray assessment also showed significantly improved knee join space and reductions in abnormal bone spur growth in the treatment group. Additionally, the treatment group had significantly lower hs-CRP compared to placebo. No adverse effects were reported. Whilst this is a small trial, Nutrition Practitioners working with patients with OA could consider the use of Boswellia serrata extract in their supplement protocols.


A double-blind, placebo-controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3-acetyl-11-keto-β-boswellic acid (AKBBA) with β-boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high-sensitive C-reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti-inflammatory/anti-arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.

Lifestyle medicine

Fundamental Clinical Imbalances : Immune and inflammation ; Structural
Patient Centred Factors : Mediators/Chronic pain/boswellia
Environmental Inputs : Nutrients
Personal Lifestyle Factors : Nutrition ; Exercise and movement
Functional Laboratory Testing : Blood ; Imaging
Bioactive Substances : Boswellia serrata

Methodological quality


Nutrition Evidence keywords : Chronic pain