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Efficacy and safety evaluation of Boswellia serrata and Curcuma longa extract combination in the management of chronic lower back pain: A randomised, double-blind, placebo-controlled clinical study.

  • 2024-12-18
  • Explore (New York, N.Y.) 21(1)
    • Anuradha Majumdar
    • Mungara Anjaneya Venkata Vara Prasad
    • Satish Reddy Gandavarapu
    • Kalakata Sudhir Kumar Reddy
    • Varun Sureja
    • Dharmeshkumar Kheni
    • Vishal Dubey

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 45
Population
Participants with CLBP (n = 45 per group, total 90)
Methods
Randomised, double-blind, placebo-controlled clinical study; 300 mg CL20192 capsule or placebo once daily for 90 days
Blinding
Double-blind
Duration
90 days
Funding
Unclear

Background and aim

Chronic lower back pain (CLBP) is a major condition that leads to disability and reduced quality of life (QoL). This randomised, double-blind, placebo-controlled clinical study evaluated the efficacy and safety of a novel Boswellia serrata and Curcuma longa combination (CL20192) for the treatment of CLBP.

Material and methods

Participants with CLBP were randomised to receive either a 300 mg CL20192 capsule (n = 45) or placebo capsule (n = 45) once daily for 90 days. Efficacy was evaluated using the Descriptor Differential Scale and Oswestry Disability Index scores for pain, unpleasantness, and disability. Additionally, the 36-item short form questionnaire was used for QoL evaluation. Frequency of painkiller use, serum levels of inflammatory biomarkers (tumour necrosis factor-α, interleukin-6, and high-sensitivity C-reactive protein), and phytoconstituents (total boswellic acids and curcuminoids) were determined. Therapy satisfaction was assessed using the Physician and Patient Global Assessment Scales.

Results

All randomised participants completed the study. CL20192 supplementation significantly reduced Descriptor Differential Scale pain, unpleasantness, and Oswestry Disability Index scores compared with the placebo group (p < 0.001 for all parameters). Critical QoL scores greatly improved in the CL20192 group. Serum phytoconstituent levels were elevated in the CL20192-treated group. This group demonstrated a significant reduction in inflammatory biomarker levels (tumour necrosis factor-α, interleukin-6, and high-sensitivity C-reactive protein), confirming efficacy in abating CLBP compared with the placebo. Moreover, therapy satisfaction scores were significantly high in the CL20192-treated group, and intervention with CL20192 was well tolerated.

Conclusion

Intervention with 300 mg CL20192 capsules, containing a novel combination of Boswellia serrata and Curcuma longa extracts, effectively alleviated pain, unpleasantness, and disability in patients with CLBP compared with the placebo. This outcome was consistent with a decrease in serum inflammatory markers and improved therapy assessment scores.

Research Insights

  • Turmeric→Improved Patient Global Assessment

    therapy satisfaction scores were significantly high in the CL20192-treated group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Improved Physician Global Assessment

    therapy satisfaction scores were significantly high in the CL20192-treated group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Improved Quality of Life

    Critical QoL scores greatly improved in the CL20192 group.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced Disability

    CL20192 supplementation significantly reduced... Oswestry Disability Index scores compared with the placebo group (p < 0.001)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced High-Sensitivity C-Reactive Protein Level

    This group demonstrated a significant reduction in inflammatory biomarker levels (...high-sensitivity C-reactive protein)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced Interleukin-6 Levels

    This group demonstrated a significant reduction in inflammatory biomarker levels (...interleukin-6...)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced Pain

    CL20192 supplementation significantly reduced Descriptor Differential Scale pain... scores compared with the placebo group (p < 0.001)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced Tumor Necrosis Factor Alpha

    This group demonstrated a significant reduction in inflammatory biomarker levels (tumour necrosis factor-α...)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
  • Turmeric→Reduced Unpleasantness

    CL20192 supplementation significantly reduced Descriptor Differential Scale... unpleasantness... scores compared with the placebo group (p < 0.001)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    300 mg CL20192 once daily
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