Majumdar Anuradha, Prasad Mungara Anjaneya Venkata Vara, Gandavarapu Satish Reddy, Reddy Kalakata Sudhir Kumar, Sureja Varun, Kheni Dharmeshkumar, Dubey Vishal
Department of Pharmacology, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, India.
Vijaya Super Speciality Hospital, Raghava Cine Complex Road, SPSR Nellore, Andhra Pradesh, India.
Explore (NY). 2025 Jan-Feb;21(1):103099. doi: 10.1016/j.explore.2024.103099. Epub 2024 Dec 18.
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.
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.
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.
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.
慢性下腰痛（CLBP）是导致残疾和生活质量（QoL）下降的主要病症。这项随机、双盲、安慰剂对照的临床研究评估了一种新型乳香和姜黄组合（CL20192）治疗CLBP的疗效和安全性。
CLBP患者被随机分为两组，一组每天服用一次300毫克CL20192胶囊（n = 45），另一组每天服用一次安慰剂胶囊（n = 45），持续90天。使用描述性差异量表和奥斯维斯特残疾指数对疼痛、不适感和残疾程度进行疗效评估。此外，使用36项简短问卷进行生活质量评估。测定止痛药使用频率、炎症生物标志物（肿瘤坏死因子-α、白细胞介素-6和高敏C反应蛋白）的血清水平以及植物成分（总乳香酸和姜黄素类）。使用医生和患者整体评估量表评估治疗满意度。
所有随机分组的参与者均完成了研究。与安慰剂组相比，补充CL20192显著降低了描述性差异量表的疼痛、不适感和奥斯维斯特残疾指数评分（所有参数p < 0.001）。CL20192组的关键生活质量评分有显著改善。CL20192治疗组的血清植物成分水平升高。该组炎症生物标志物水平（肿瘤坏死因子-α、白细胞介素-6和高敏C反应蛋白）显著降低，证实与安慰剂相比，CL20192在减轻CLBP方面具有疗效。此外，CL20192治疗组的治疗满意度评分显著较高，且CL20192干预耐受性良好。
与安慰剂相比，服用含有新型乳香和姜黄提取物组合的300毫克CL20192胶囊对CLBP患者的疼痛、不适感和残疾状况有有效缓解作用。这一结果与血清炎症标志物的降低以及治疗评估评分的改善相一致。
