[Therapy of active Crohn disease with Boswellia serrata extract H 15]. Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Randomized, placebo‐controlled, double‐blind trial of Boswellia serrata in maintaining remission of Crohn's disease: Good safety profile but lack of efficacy Effects of Boswellia serrata gum resin in patients with ulcerative colitis. Effects of Boswellia serrata gum resin in patients with bronchial asthma: results of a double-blind, placebo-controlled, 6-week clinical study. Boswellia serrata extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter trial Effects of gum resin of Boswellia serrata in patients with chronic colitis. The use of an anti-inflammatory supplement in patients with chronic kidney disease Comparative Efficacy and Tolerability of 5-Loxin® and Aflapin® Against Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study Topical Boswellic acids for treatment of photoaged skin. Effects of topical boswellic acid on photo and age-damaged skin: clinical, biophysical, and echographic evaluations in a double-blind, randomized, split-face study. Curcumin and Boswellia serrata Modulate the Glyco-Oxidative Status and Lipo-Oxidation in Master Athletes A Placebo-Controlled Double-Blind Study Demonstrates the Clinical Efficacy of a Novel Herbal Formulation for Relieving Joint Discomfort in Human Subjects with Osteoarthritis of Knee. Clinical comparison of oral administration and viscosupplementation of hyaluronic acid (HA) in early knee osteoarthritis
BACKGROUND The purpose of this clinical trial was to compare efficacy and safety of the Boswellia serrata extract H15 with mesalazine for the treatment of active Crohn 's disease . PATIENTS AND METHODS R and omised , double-blind , verum-controlled , parallel group comparison for which 102 Patients were r and omised . The per protocol population included 44 patients treated with H15 and 39 patients treated with mesalazine .  As primary outcome measure the change of the Crohn Disease Activity Index ( CDAI ) between the status of enrolment and end of therapy was chosen . H 15 was tested on non-inferiority compared to st and ard treatment with mesalazine . RESULTS The CDAI between the status of enrolment and end of therapy after treatment with H15 was reduced by 90 and after therapy with mesalazine by 53 scores in the mean . In this non-inferiority-trial the test hypothesis was confirmed by the statistical analysis . The difference between both treatments could not be proven to be statistically significant in favor to H15 for the primary outcome measure . The secondary efficacy endpoints confirm the assessment of the comparison of H15 and mesalazine . The proven tolerability of H15 completes the results of the shown clinical efficacy . CONCLUSIONS The study confirms that therapy with H15 is not inferior to mesalazine . This can be interpreted as evidence for the efficacy of H15 according to the state of art in the treatment of active Crohn 's disease with Boswellia serrata extract , since the efficacy of mesalazine for this indication has been approved by the health authorities . Considering both safety and efficacy of Boswellia serrata extract H15 it appears to be superior over mesalazine in terms of a benefit-risk-evaluation Osteoarthritis is a common , chronic , progressive , skeletal , degenerative disorder , which commonly affects the knee joint . Boswellia serrata tree is commonly found in India . The therapeutic value of its gum ( guggulu ) has been known . It posses good anti-inflammatory , anti-arthritic and analgesic activity . A r and omized double blind placebo controlled crossover study was conducted to assess the efficacy , safety and tolerability of Boswellia serrata Extract ( BSE ) in 30 patients of osteoarthritis of knee , 15 each receiving active drug or placebo for eight weeks . After the first intervention , washout was given and then the groups were crossed over to receive the opposite intervention for eight weeks . All patients receiving drug treatment reported decrease in knee pain , increased knee flexion and increased walking distance . The frequency of swelling in the knee joint was decreased . Radiologically there was no change . The observed differences between drug treated and placebo being statistically significant , are clinical ly relevant . BSE was well tolerated by the subjects except for minor gastrointestinal ADRs . BSE is recommended in the patients of osteoarthritis of the knee with possible therapeutic use in other arthritis Background : Complementary therapies are frequently used by patients with inflammatory bowel disease ( IBD ) . The aim of this study was to evaluate the efficacy and safety of long‐term therapy with a new Boswellia serrata extract ( Boswelan , PS0201Bo ) in maintaining remission in patients with Crohn 's disease ( CD ) . Methods : In 22 German centers a double‐blind , placebo‐controlled , r and omized , parallel study was performed . In all , 108 out patients with CD in clinical remission were included . Patients were r and omized to Boswelan ( 3 × 2 capsules/day ; 400 mg each ) or placebo for 52 weeks . The primary endpoint was the proportion of patients in whom remission was maintained throughout the 52 weeks . Secondary endpoints were time to relapse , changes of Crohn 's Disease Activity Index ( CDAI ) , and IBD Question naire ( IBDQ ) scores . Results : The trial was prematurely terminated due to insufficient discrimination of drug and placebo with regard to the primary efficacy endpoint . A total of 82 patients were r and omized to Boswelan ( n = 42 ) or placebo ( n = 40 ) . Sixty‐six patients could be analyzed for efficacy . 59.9 % of the actively treated patients and 55.3 % of the placebo group stayed in remission ( P = 0.85 ) . The mean time to diagnosis of relapse was 171 days for the active group and 185 days for the placebo group ( P = 0.69 ) . With respect to CDAI , IBDQ , and laboratory measurements of inflammation , no advantages in favor of active treatment were detected . Regarding safety concerns , no disadvantages of taking the drug compared to placebo were observed . Conclusions : The trial confirmed good tolerability of a new Boswellia serrata extract , Boswelan , in long‐term treatment of CD . However , superiority versus placebo in maintenance therapy of remission could not be demonstrated . ( Inflamm Bowel Dis 2011 Ulcerative colitis is a chronic inflammatory disease of the colon where leukotrienes are suggested to play an important role for keeping inflammation active . Boswellic acids , the biologically active ingredients of the gum resin of Boswellia serrata ( Sallai guggal ) , have been shown to be specific , nonredox and noncompetitive inhibitors of 5-lipoxygenase , the key enzyme of leukotriene bio synthesis . In patients suffering from ulcerative colitis grade II and III the effect of Boswellia serrata gum resin preparation ( 350 mg thrice daily for 6 weeks ) on stool properties , histolopathology and scan microscopy of rectal biopsies , blood parameters including Hb , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils was studied . Patients receiving sulfasalazine ( 1 g thrice daily ) served as controls . All parameters tested improved after treatment with Boswellia serrata gum resin , the results being similar compared to controls : 82 % out of treated patients went into remission ; in case of sulfasalazine remission rate was 75 % The gum resin of Boswellia serrata , known in Indian Ayurvedic system of medicine as Salai guggal , contains boswellic acids , which have been shown to inhibit leukotriene bio synthesis . In a double-blind , placebo-controlled study forty patients , 23 males and 17 females in the age range of 18 - 75 years having mean duration of illness , bronchial asthma , of 9.58 + /- 6.07 years were treated with a preparation of gum resin of 300 mg thrice daily for a period of 6 weeks . 70 % of patients showed improvement of disease as evident by disappearance of physical symptoms and signs such as dyspnoea , rhonchi , number of attacks , increase in FEV subset1 , FVC and PEFR as well as decrease in eosinophilic count and ESR . In the control group of 40 patients 16 males and 24 females in the age range of 14 - 58 years with mean of 32.95 + /- 12.68 were treated with lactose 300 mg thrice daily for 6 weeks . Only 27 % of patients in the control group showed improvement . The data show a definite role of gum resin of Boswellia serrata in the treatment of bronchial asthma Background and aims The objective of this study was to investigate the effect of Boswellia serrata extract ( BSE ) on symptoms , quality of life , and histology in patients with collagenous colitis . Material s and methods Patients with chronic diarrhea and histologically proven collagenous colitis were r and omized to receive either oral BSE 400 mg three times daily for 6 weeks or placebo . Complete colonoscopy and histology were performed before and after treatment . Clinical symptoms and quality of life were assessed by st and ardized question naires and SF-36 . The primary endpoint was the percentage of patients with clinical remission after 6 weeks ( stool frequency ≤3 soft /solid stools per day on average during the last week ) . Patients of the placebo group with persistent diarrhea received open-label BSE therapy for a further 6 weeks . Results Thirty-one patients were r and omized ; 26 patients were available for per- protocol - analysis . After 6 weeks , the proportion of patients in clinical remission was higher in the BSE group than in the placebo group ( per protocol 63.6 % ; 95%CI , 30.8–89.1 vs 26.7 % , 95%CI , 7.7–55.1 ; p = 0.04 ; intention-to-treat 43.8 % vs 26.7 % , p = 0.25 ) . Compared to placebo , BSE treatment had no effect on histology and quality of life . Five patients discontinued BSE treatment prematurely . Discontinuation was due to adverse events ( n = 1 ) , unwillingness to continue ( n = 3 ) , or loss to follow-up for unknown reasons ( n = 1 ) . Seven patients received open-label BSE therapy , five of whom achieved complete remission . Conclusions Our study suggests that BSE might be clinical ly effective in patients with collagenous colitis . Larger trials are clearly necessary to establish the clinical efficacy of BSE Patients studied here suffered from chronic colitis characterized by vague lower abdominal pain , bleeding per rectum with diarrhoea and palpable tender descending and sigmoid colon . The inflammatory process in colitis is associated with increased formation of leukotrienes causing chemotaxis , chemokinesis , synthesis of superoxide radicals and release of lysosomal enzymes by phagocytes . The key enzyme for leukotriene bio synthesis is 5-lipoxygenase . Boswellic acids were found to be non-redox , non-competitive specific inhibitors of the enzyme 5-lipoxygenase . We studied the gum resin of Boswellia serrata for the treatment of this disease . Thirty patients , 17 males and 13 females in the age range of 18 to 48 years with chronic colitis were included in this study . Twenty patients were given a preparation of the gum resin of Boswellia serrata ( 900 mg daily divided in three doses for 6 weeks ) and ten patients were given sulfasalazine ( 3 gm daily divided in three doses for 6 weeks ) and served as controls . Out of 20 patients treated with Boswellia gum resin 18 patients showed an improvement in one or more of the parameters : including stool properties , histopathology as well as scanning electron microscopy , besides haemoglobin , serum iron , calcium , phosphorus , proteins , total leukocytes and eosinophils . In the control group 6 out of 10 patients showed similar results with the same parameters . Out of 20 patients treated with Boswellia gum resin 14 went into remission while in case of sulfasalazine  remission rate was 4 out of 10 . In conclusion , this study shows that a gum resin preparation from Boswellia serrata could be effective in the treatment of chronic colitis with minimal side effects Abstract Chronic kidney disease ( CKD ) is characterized by a continuous reduction in kidney function , increased inflammation , and reduced antioxidant capacity . The objective of this study was to assess the effects of a herbal supplement on systemic inflammation and antioxidant status in non-dialysis CKD patients . Sixteen patients with CKD ( 56.0±16.0 yrs , 171.4±11.9 cm , 99.3±20.2 kg ) were r and omly chosen to receive a herbal supplement composed of Curcuma longa and Boswellia serrata , or placebo . Plasma levels of interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNF-α ) , glutathione peroxidase ( GPx ) , and serum C-reactive protein ( CRP ) were measured at baseline and 8 weeks . Baseline data demonstrated elevated inflammation and low antioxidant levels . A significant time effect ( p=0.03 ) and time x compliance interaction effect ( p=0.04 ) were observed for IL-6 . No significant differences were observed for any other variables . This study demonstrates that mild and moderate CKD is associated with chronic inflammation and low antioxidant activity . Systemic inflammation and impaired antioxidant status may be greater in CKD population s with multiple comorbidities . Curcumin and Boswellia serrata are safe and tolerable and helped to improve the levels of an inflammatory cytokine Aflapin ® is a novel synergistic composition derived from Boswellia serrata gum resin ( Indian Patent Application No. 2229/CHE/2008 ) . Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market . A 90-day , double-blind , r and omized , placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin ® and Aflapin ® in the treatment of osteoarthritis ( OA ) of the knee ( Clinical trial registration number : IS RCT N80793440 ) . Sixty OA subjects were included in the study . The subjects received either 100 mg ( n=20 ) of 5-Loxin ® or 100 mg ( n=20 ) of Aflapin ® or a placebo ( n=20 ) daily for 90 days . Each patient was evaluated for pain and physical functions by using the st and ard tools ( visual analog scale , Lequesne 's Functional Index , and Western Ontario and McMaster Universities Osteoarthritis Index ) at the baseline ( day 0 ) , and at days 7 , 30 , 60 and 90 . A battery of biochemical parameters in serum , urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin ® and Aflapin ® in OA subjects . Fifty seven subjects completed the study . At the end of the study , both 5-Loxin ® and Aflapin conferred clinical ly and statistically significant improvements in pain scores and physical function scores in OA subjects . Interestingly , significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin . Corroborating the improvements in pain scores in treatment groups , our in vitro studies provide evidence s that Aflapin ® is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1 . Aflapin ® and 5-Loxin ® reduce pain and improve physical functions significantly in OA subjects . Aflapin exhibited better efficacy compared to 5-Loxin ® . In comparison with placebo , the safety parameters were almost unchanged in the treatment groups . Hence both 5-Loxin ® and Aflapin ® are safe for human consumption Boswellic acids ( BAs ) are pentacyclic triterpenes extracted from the gum resins of the tropical tree Boswellia serrata . They are orally administered in traditional Indian medicine for the treatment of several inflammatory disease and cancer because of their anti-inflammatory and immunomodulatory activities as well as stimulatory effects on fibroblasts . The present authors have investigated efficacy , tolerability , and safety of a base cream containing 0.5 % BAs in the treatment of clinical manifestations of photoaging of facial skin with a r and omized , double-blind , placebo-controlled , split-face study . Fifteen female volunteers applied the creams with or without BAs on the half sides of the face once daily for 30 days . Significant improvements of the Dover 's global score for photoaging , tactile roughness , and fine lines , as well as , with noninvasive diagnostic techniques , an increase of elasticity , a decrease of sebum excretion , and a change of echographic parameters were observed with topical BAs in comparison with placebo . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that topical application of BAs may represent a suitable treatment option for selected features of skin photoaging Boswellic acids ( BAs ) are pentacyclic triterpenes with strong anti-inflammatory activity ; their most important source is the extract of the gum resin of Boswellia serrata , a tropical tree that grows in India and Africa . In the present r and omized , double-blind , split-face , comparative study we have assessed efficacy , tolerability , and safety of a base cream containing 0.5 % BAs as compared to the same cream without these active ingredients in the treatment of clinical manifestations of photoaging of facial skin . Fifteen female volunteers were enrolled ; they applied creams once daily for 30 days . At baseline , at the end of the treatment , and after a 2-month follow-up , clinical findings were assessed according to the Dover classification scale for photoaging and by biophysical and ecographic measurements . We registered a significant improvement of tactile roughness and fine lines in the half side of the face treated with BAs ; noninvasive instrumental diagnostic investigations showed an improvement of elasticity , a decrease of sebum excretion , and a change of echographic parameters suggesting a reshaping of dermal tissue . The treatment was always well tolerated without adverse effects . The present findings seem to indicate that the topical application of BAs may represent a suitable treatment option for selected features of skin photoaging Background : Chronic intensive exercise is associated with a greater induction of oxidative stress and with an excess of endogenous advanced glycation end-products ( AGEs ) . Curcumin can reduce the accumulation of AGEs in vitro and in animal models . We examined whether supplementation with curcumin and Boswellia serrata ( BSE ) gum resin for 3 months could affect plasma levels of markers of oxidative stress , inflammation , and glycation in healthy master cyclists . Methods . Forty-seven healthy male athletes were r and omly assigned to Group 1 , consisting of 22 subjects given a Mediterranean diet ( MD ) alone ( MD group ) , and Group 2 consisted of 25 subjects given a MD plus curcumin and BSE ( curcumin/BSE group ) . Interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNFα ) , high-sensitivity c-reactive protein ( hs-CRP ) , total AGE , soluble receptor for AGE ( sRAGE ) , malondialdehyde ( MDA ) , plasma phospholipid fatty acid ( PPFA ) composition , and non-esterified fatty acids ( NEFA ) were tested at baseline and after 12 weeks . Results : sRAGE , NEFA , and MDA decreased significantly in both groups , while only the curcumin/BSE group showed a significant decline in total AGE . Only the changes in total AGE and MDA differed significantly between the curcumin/BSE and MD groups . Conclusions . Our data suggest a positive effect of supplementation with curcumin and BSE on glycoxidation and lipid peroxidation in chronically exercising master athletes LI73014F2 is a novel composition prepared from extracts of Terminalia chebula fruit , Curcuma longa rhizome , and Boswellia serrata gum resin with synergistic benefit in 5-Lipoxygenase ( 5-LOX ) inhibition . This herbal composition with strong anti-5-LOX activity exhibited significant pain relief as indicated through improvements in weight-bearing capacity in a monosodium iodoacetate-induced osteoarthritis ( OA ) model of Sprague-Dawley rats . A 90-day r and omized , placebo-controlled double-blind study evaluates the clinical efficacy and tolerability of LI73014F2 in the management of symptoms of OA of the knee ( Clinical Trial Registration No. CTRI/2014/01/004338 ) . Subjects , ( n = 105 ) , were r and omized into three groups : placebo ( n = 35 ) , 200 mg/day of LI73014F2 ( n = 35 ) , and 400 mg/day of LI73014F2 ( n = 35 ) . All study participants were evaluated for pain and physical function by using st and ard tools , that is , Visual Analog Scale , Lequesne 's Functional Index , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) at the baseline ( day 0 ) and on day 14 ± 3 , 30 ± 3 , 60 ± 3 , and at the end of the study ( day 90 ± 3 ) . In addition , routine examinations on biochemical parameters in serum , urine , and hematological parameters were conducted on each visit to assess the safety of the study material . At the end of the trial period , LI73014F2 conferred significant pain relief , improved physical function , and quality of life in OA patients . In conclusion , pre clinical and clinical data together strongly suggest that the herbal formulation LI73014F2 is a safe and effective intervention for management of joint discomfort , demonstrating efficacy as early as 14 days Purpose Osteoarthritis ( OA ) is a progressive , chronic and degenerative joint disease characterized by a loss of articular cartilage . Treatment of OA is largely palliative based on nonsteroidal anti-inflammatory drugs , opioids and injections of steroids . Regarding conservative treatment , intra-articular injections of hyaluronic acid ( HA ) can play a role in early symptomatic knee OA . Material s and methods Between August 2015 and September 2015 , sixty patients ( 32 males and 28 females ) between 40 and 70 years old were r and omly allocated into two groups : Half were treated with three weekly intra-articular injections of hyaluronic acid 1.6 % ( group A ) , while the others were treated with Syalox 300 Plus ® ( hyaluronic acid 300 mg + Boswellia serrata extract 100 mg ) 1 tab/die for 20 days and afterward Syalox 150 ® ( hyaluronic acid 150 mg ) 1 tab/die for other 20 days ( group B ) . All patients were evaluated clinical ly with American Knee Society Score ( AKSS ) and visual analogue scale ( VAS ) for the pain before the treatment and after 3 months . Results AKSS of the patients in both groups was significantly increased by the treatment , and VAS score was significantly reduced . In both groups , two subgroups were created with patients older than 60 years and patients younger than 60 years . Better results are reported in younger patients of group A and older subjects in group B. Conclusions Despite several limitations , the results of the study have shown that HA injection and oral administration may have beneficial therapeutic effects on patients with early osteoarthritis . Different outcomes in younger and older subject suggested a combined therapy first with local infiltrations and then with oral composition
The evidence for the effectiveness of B serrata extracts is encouraging but not compelling
OBJECTIVE To assess evidence from r and omised clinical trials about the effectiveness of  extracts of Boswellia serrata ( frankincense ) .