A novel herbal composition containing extracts of Boswellia serrata gum resin and Aegle marmelos fruit alleviates symptoms of asthma in a placebo controlled double‐blind clinical study

• Published in: Phytotherapy research Vol. 32; no. 1; pp. 140 - 150
• Main Authors: Yugandhar, Pothina, Rao, Konda Manikyeswara, Sengupta, Krishanu
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.01.2018
• Subjects: Aegle marmelos; Alveoli; AlvioLife; Arachidonate 5-lipoxygenase; Asthma; blood serum; Boswellia Serrata; clinical study; Clinical trials; Double-blind studies; Fruits; Inflammation; Inhibition (psychology); interferon-gamma; Interleukin 4; Leukocytes (granulocytic); LI13109F; Lipoxygenase; Lymphocytes T; placebos; Rats; Respiratory tract; Respiratory tract diseases; Supplements; clinical study; Boswellia Serrata; LI13109F; asthma; Aegle marmelos; AlvioLife
• ISSN: 0951-418X; 1099-1573; 1099-1573
• DOI: 10.1002/ptr.5963

LI13109F is a novel herbal composition containing the extracts of Boswellia serrata gum resin and Aegle marmelos fruit. This composition dampens leukotriene dependent inflammatory reactions via inhibiting 5‐lipoxygenase pathway. In a Sephadex LH‐20 induced airway inflammation model of Sprague Dawley rats, LI13109F significantly reduced infiltrated granulocyte population in the bronco‐alveolar lavage fluid and normalized Th1/Th2 cytokine balance. Further, a 56‐day placebo‐controlled and randomized double blind study (Clinical Trial Registration No. CTRI/2016/10/007393) on subjects with mild to moderate asthma has evaluated the clinical efficacy of LI13109F. The study subjects received either 200 mg/day of LI13109F (n = 18) or a similar dosage of placebo (n = 18). At the end of the trial period, LI13109F conferred significant improvements in the clinical parameters; the emotional function (p = .0305) and asthma symptoms scores (p = .0002) were improved even at 14 days, compared with the placebo. Further, 56 days supplementation of LI13109F resulted in significant increase in serum IFN‐γ (p = .0014) and reduction in IL‐4 (p = .0497), compared with placebo. LI13109F supplementation did not yield any serious adverse events or any abnormal observations in routine laboratory examinations during the study. Together, these observations suggest that LI13109F (AlvioLife®) is tolerable and an effective intervention for management of mild to moderate asthma such as airway inflammation.