Introduction

Chronic lower back pain (CLBP) has 23% prevalence in older adults and working individuals and leads to disability (12%) and reduced quality of life (QoL). Pain and disturbed motor control are commonly linked to it. Common analgesics like paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) form the first-line therapy. Muscle relaxants, tricyclic antidepressants, and opioids provide pain relief. However, these are associated with high risk of gastrointestinal, cardiovascular side effects, and tremors. Data suggested that low-grade chronic inflammation may be a major factor in the development and/or progression of CLBP. Boswellia serrata is widely used to treat various inflammatory diseases and Curcuma longa (turmeric) exerts anti-inflammatory properties by inhibiting cyclooxygenase-2, inducible nitric oxide synthase, and lipoxygenase and also by peroxisome proliferator-activated receptor-gamma activation. Clinical studies have evaluated the effects of B. serrata and C. longa therapy in various painful conditions. However, no clinical study, till date, has evaluated the efficacy of this combination in nonspecific CLBP.

Aim

To evaluate the efficacy and safety of a novel Boswellia serrata gum resin and Curcuma longa rhizome extract combination (CL20192) for the treatment of nonspecific CLBP

Patient Profile

• 90 participants (aged 21–60 years) with self-reported LBP of moderate intensity that had an impact on >2 aspects of daily activity in the last 12 weeks

Method

Study Design

• Multicentre, randomised, double-blind, placebo-controlled clinical study
• Participants with CLBP were randomised to receive either a 300 mg CL20192 capsule or placebo capsule once daily for 90 days

Endpoints

• Primary evaluation parameter: Reduction in the Descriptor Differential Scale (DDS) score (assessed sensory intensity and unpleasantness)
• Secondary evaluation parameters: Changes in the Oswestry Disability Index (ODI), 36-item short form (SF-36) questionnaire used for QoL evaluation, and Physician and Patient Global Assessment scale used to assess therapy satisfaction
• Serum levels of inflammatory biomarkers (tumour necrosis factor-alpha, interleukin-6, and high-sensitivity C-reactive protein), and phytoconstituents (total boswellic acids and curcuminoids) were determined
• Frequency of painkiller use

Results

Efficacy

• CL20192 supplementation significantly reduced DDS-pain and DDS-unpleasantness scores as compared to baseline and placebo group (p < 001 for both) starting from day 30 whereas in placebo group, the improvement in the DDS-pain score was significant at days 60 and 90 versus baseline and no improvement was seen in the DDS-unpleasantness score
• CL20192 supplementation significantly and progressively improved ODI scores versus baseline and placebo (p < 001 for both); while the ODI scores significantly improved in placebo group only on day 90 (p < 0.01) versus the respective baseline
• The SF-36 scores for QoL improved significantly in the CL20192 group after 90 consecutive days of supplementation versus the placebo group (p < 05) for all parameters except general health
• Improvements in the global assessment scales of both physicians and patients were significant in the CL20192 supplementation group compared with those in the placebo group (Figure 1a and b)
• After 90 days of supplementation, less patients consumed rescue medications in the CL20192 group (9 vs. 4) and more patients in placebo group versus baseline (5 vs. 7)
• Supplementation with CL20192 significantly reduced the levels of inflammatory biomarker hs-CRP and TNF-alpha compared to both the baseline values and placebo group, confirming efficacy in abating CLBP (Table 1)
• Serum phytoconstituent (boswellic acids and curcuminoids) levels were elevated in the CL20192-treated group than in the placebo group
• Overall painkiller usage decreased in 11.11 % participants in the CL20192 group after 90 days of therapy 

Figure 1: Efficacy of CL20192 supplementation: (a) Physician and (b) Patient global assessment scales

(a)

 

(b)

 

Table 1: Effect of interventions on serum inflammatory biomarkers level

Variables	Placebo	CL20192	p-value
hs-CRP (mg/L)	0.216	0.176	0.0004
TNF-alpha (pg/mL)	1.20	0.85	0. 0110

Safety 

• CL20192 treatment was well-tolerated
• Participants reported adverse events, including headache, fever, nausea, stomach pain, body pain, leg pain, and diarrhoea, however, none of them were related to CL20192 supplementation
• Therapy satisfaction scores were significantly high in CL20192 group
• The routine haematology and clinical chemistry parameters and the participants’ vital signs were unaltered during the trial and remained within the normal laboratory ranges which supported the safety profile of CL20192 for long-term use
• The metabolic markers, creatinine, blood urea nitrogen, aspartate aminotransferase, alanine transaminase, alkaline phosphatase, and albumin levels, were within the normal range

Conclusion

The novel combination of Boswellia serrata and Curcuma longa extracts in 300 mg capsules was safe, well-tolerated and effectively alleviated pain intensity, unpleasantness, disability and inflammation in patients with moderate nonspecific CLBP as compared with placebo.

Explore 2025; 21: 103099