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Abstract Context The Short Synacthen Test (SST) is the gold standard for diagnosing adrenal insufficiency. It requires invasive administration of Synacthen, venous sampling, and is resource-intensive. Objective To develop a nasally administered SST, with salivary glucocorticoids measurement, to assess the adrenal response. Design We conducted 5 studies: 4 open-label, sequence-randomized, crossover, pharmacodynamic studies testing 6 doses/formulations and a repeatability study. Additionally, pharmacokinetic analysis was undertaken using our chosen formulation, 500 µg tetracosactide with mucoadhesive chitosan, Nasacthin003, in our pediatric study. Setting Adult and children’s clinical research facilities. Participants A total of 36 healthy adult males and 24 healthy children. Intervention We administered all 6 nasal formulations using an European regulator endorsed atomization device. The IV comparators were 250 µg or 1 µg SST. Main Outcome Measures We analyzed paired blood and saliva samples for plasma cortisol and salivary cortisol and cortisone. Results The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively). The bioavailability of Nasacthin003 was 14.3%. There was no significant difference in plasma cortisol at 60 minutes between 500 µg Nasacthin003 and 250 µg IV Synacthen (P = 0.17). The repeatability coefficient at 60 minutes was 105 nmol/L for IV Synacthen and salivary cortisol and cortisone was 10.3 and 21.1 nmol/L, respectively. The glucocorticoid response in children was indistinguishable from that of adults. Conclusions Nasal administration of Nasacthin003 generates equivalent plasma cortisol values to the 250-µg IV SST and, with measurement at 60 minutes of salivary cortisol or cortisone, provides a noninvasive test for adrenal insufficiency.

Background. Noroviruses cause significant morbidity and mortality from acute gastroenteritis in all age groups worldwide. Methods.We conducted 2 phase 1 double-blind, controlled studies of a virus-like particle (VLP) vaccine derived from norovirus GI.1 genotype adjuvanted with monophosphoryl lipid A (MPL) and the mucoadherent chitosan. Healthy subjects 18–49 years of age were randomized to 2 doses of intranasal Norwalk VLP vaccine or controls 21 days apart. Study 1 evaluated 5-, 15-, and 50-μg dosages of Norwalk antigen, and study 2 evaluated 50-and 100-μg dosages. Volunteers recorded symptoms for 7 days after dosing, and safety was followed up for 180 days. Blood samples were collected for serological profile, antibody secreting cells (ASCs), and analysis of ASC homing receptors. Results. The most common symptoms were nasal stuffiness, discharge, and sneezing. No vaccine-related serious adverse events occurred. Norwalk VLP-specific immunoglobulin G and immunoglobulin A antibodies increased 4.8-and 9.1-fold, respectively, for the 100-μg dosage level. All subjects tested who received the 50-or 100-μg vaccine dose developed immunoglobulin A ASCs. These cells expressed molecules associated with homing to mucosal and peripheral lymphoid tissues. Conclusions. The intranasal monovalent adjuvanted Norwalk VLP vaccine was well tolerated and highly immunogenic and is a candidate for additional study. Trial Registration. ClinicalTrials.gov identifier: NCT00806962.

Background Non-alcoholic fatty liver disease (NAFLD) is a disease with high complications. An increment in dietary fiber consumption is an approach to NAFLD management, and chitosan as dietary fiber can play a role in the management of NAFLD. Thus, the present study aimed to investigate the effect of chitosan supplementation on liver function, hepatic steatosis predictors, and metabolic indices in adults with NAFLD. Methods Seventy-two adults with NAFLD were randomly assigned to consume either 1.5 g/day chitosan or placebo along with a low-calorie (− 500 kcal/day) diet for 8 weeks in a parallel, randomized, double-blinded, placebo-controlled, clinical trial. Participants were assessed for dietary intake, physical activity, and anthropometric indices. Blood samples were taken to measure fasting blood sugar (FBS), cholesterol, triglycerides, high- and low-density lipoprotein (HDL and LDL). Liver function indices including alanine aminotransferase (ALT), aspartate transaminase (AST), and gamma-glutamyltransferase (GGT) were evaluated using blood samples as the primary outcomes. Fatty liver index (FLI), hepatic steatosis index (HSI), and triglyceride-glucose index (TyG) were calculated as hepatic steatosis predictors’ indices. Results After 8 weeks of study, 66 participants finished the study. In comparison with placebo, chitosan supplementation reduced weight ( P  = 0.041), waist circumference ( P  = 0.049), AST ( P  = 0.040), ALT ( P  = 0.001), and GGT ( P  = 0.028). Although the reduction of FBS, triglycerides, cholesterol, LDL, FLI, HSI, and TyG, and increment in HDL was higher in the chitosan group, the results were not significant ( P  > 0.05). Conclusions Eight-week supplementation with 1.5 g/day chitosan along with a low-calorie diet could possibly reduce weight, waist circumference, AST, ALT, and GGT, and ameliorate NAFLD. Further investigations are recommended. Trial registration The trial was registered at IRCT.ir as IRCT20140502017522N4 (March 2023).

Objectives The current literature lacks the effect of melatonin loaded nanoparticles (LNPs) as local drug delivery (LDD) in the treatment of periodontitis. Hence, the aim of the current study is to investigate the clinical and radiographic effects of melatonin LNPs in patients with periodontal intrabony defects. Methods The current study was performed on healthy patients with periodontal intrabony defects. The participants were randomly allocated into 3 groups. Group 1 received scaling and root planing (SRP) with melatonin LNPs, group 2 received placebo gel with SRP, and group 3 received SRP and chitosan LNPs. The primary outcomes included the radiographic measurements of the bone defects to evaluate the bone fill after 6 months. The secondary outcomes included the following clinical parameters; clinical attachment level (CAL), periodontal probing depth (PPD), plaque index (PI), and gingival index (GI). The clinical parameters were evaluated at baseline, 3 months, and 6 months. Results The current study included 67 patients with periodontal intrabony defects. All the study groups demonstrated significant improvements in all the clinical outcomes (CAL, PPD, PI, and GI) (P < 0.05). Melatonin LNPs group revealed the most significant improvement of the radiographic outcomes after 6 months including bone defect height and depth, alveolar crest level, and the buccolingual and mesiodistal width of bone defects) (P < 0.05), followed by chitosan group while insignificant changes were detected in the placebo group (P > 0.05). Conclusion Melatonin LNPs as a LDD can act as a promising therapeutic modality in treating periodontal intrabony defects through significant improvement of the clinical and radiographic outcomes.

Atopic dermatitis (AD) patients may benefit from using textiles coated with skin microbiome-modulating compounds. Chitosan, a natural biopolymer with immunomodulatory and antimicrobial properties, has been considered potentially useful. This randomized controlled trial assessed the clinical utility of chitosan-coated garment use in AD. Of the 102 patients screened, 78 adult and adolescents were randomly allocated to overnight use of chitosan-coated or uncoated cotton long-sleeved pyjama tops and pants for 8 weeks. The primary outcome was change in disease severity assessed by Scoring Atopic dermatitis index (SCORAD). Other outcomes were changes in quality of life, pruritus and sleep loss, days with need for rescue medication, number of flares and controlled weeks, and adverse events. Changes in total staphylococci and Staphylococcus aureus skin counts were also assessed. Comparisons were made using analysis of variance supplemented by repeated measures analysis for the primary outcome. Interaction term between time and intervention was used to compare time trends between groups. Chitosan group improved SCORAD from baseline in 43.8%, (95%CI: 30.9 to 55.9), P = 0.01, placebo group in 16.5% (-21.6 to 54.6); P = 0.02 with no significant differences between groups; Dermatology Quality of life Index Score significantly improved in chitosan group (P = 0.02) and a significant increase of skin Coagulase negative Staphylococci (P = 0.02) was seen. Chitosan coated textiles may impact on disease severity by modulating skin staphylococcal profile. Moreover, a potential effect in quality of life may be considered. ClinicalTrials.gov NCT01597817.

IntroductionTo assess the efficacy of a chitosan-based gel (ChitoCare) for the treatment of non-healing diabetic foot ulcers (DFUs).Research design and methodsForty-two patients with chronic DFUs were randomized to the ChitoCare or placebo gel for a 10-week treatment period and 4-week follow-up. The primary study end point was the rate of complete wound closure at week 10, presented as relative rate.ResultsThirty patients completed the 10-week treatment and 28 completed the 4-week follow-up. The ChitoCare arm achieved 16.7% complete wound closure at week 10 vs 4.2% in the placebo arm (p=0.297), 92.0% vs 37.0% median relative reduction in wound surface area from baseline at week 10 (p=0.008), and 4.62-fold higher likelihood of achieving 75% wound closure at week 10 (p=0.012). Based on the results of the Bates-Jensen Wound Assessment Tool, the wound state at week 10 and the relative improvement from the baseline were significantly better (median 20 vs 24 points, p=0.018, and median 29.8% vs 3.6%, p=0.010, respectively).ConclusionsChitoCare gel increased the rate of the DFU healing process. Several secondary end points significantly favored ChitoCare gel.Trial registration numberNCT04178525.

Cubital tunnel syndrome (CBTS) impairs hand function, with limited conservative options often leading to surgery. Chitosan neuroregenerative effects delivered via phonophoresis provide a rationale for testing this emerging treatment approach. The primary goal of this research was to assess the impact of chitosan phonophoresis on the conductivity of the ulnar nerve, as well as its effects on pain levels and functional outcomes in individuals diagnosed with mild to moderate CBTS. Double-blind randomized controlled trial. This was a prospective, double-blinded, randomized controlled study. The participants consisted of 54 individuals aged between 20–35 years who were randomly assigned using block randomization. The control group (n = 27) received standard hand therapy alone, while the experimental group (n = 27) received both standard hand therapy and chitosan phonophoresis. Both groups underwent three treatment sessions per week, each lasting for 60–72 minutes, over a period of five weeks. Pre- and post-intervention evaluations included assessments of ulnar nerve conduction velocity (NCV), pain assessment using the numerical pain rating scale (NPRS), as well as hand function evaluated using the Quick Disabilities of Arm Shoulder Hand (QuickDASH) questionnaire. After the intervention, the experimental group significantly improved in all outcome measures compared to the control group. Accordingly, ulnar NCV (MD = 2.233 m/sec; CI = 1.63:2.83; p < 0.001; η2p = 0.516), NPRS (MD = −1.11; CI = −1.71: −0.50; p < 0.001; η2p = 0.208) and QuickDASH (MD = −2.72; CI = −4.54:0.87; p < 0.007; η2p = 0.133). The study findings suggest that chitosan phonophoresis may have the potential as a supplementary treatment to hand therapy for individuals with mild to moderate CBTS. This approach demonstrated significant improvements in nerve conduction, pain reduction, and enhancement of hand function. •Chitosan phonophoresis is a novel treatment approach for cubital tunnel syndrome.•Cubital tunnel syndrome impairs hand function, with limited effective conservative options.•Chitosan phonophoresis improved ulnar nerve conduction velocity versus standard care.•Chitosan phonophoresis provided greater pain relief compared to physical therapy alone.•Chitosan's neuroprotective effects make it well-suited for nerve compression disorders.

Background Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions. Methods A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500 mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90 days. The study participants were divided in 2:1 ratio to receive either chitosan ( n  = 64) or placebo ( n  = 32). Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. Also, short form-36 quality of life (QoL) questionnaire was assessed to evaluate improvement in life-style and dietary habits were recorded for calorie intake. Safety was assessed by evaluating safety parameters and monitoring adverse events. Results The mean changes in body weight were -1.78 ± 1.37 kg and -3.10 ± 1.95 kg at day 45 and day 90 respectively in chitosan group which were significantly different ( p  < 0.0001) as compared to placebo. BMI was decreased by10.91 fold compared to placebo after 90 day administration. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Chitosan was also able to reduce HbA1C levels (below 6 %) in subjects who had initial higher values. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment. Conclusion Chitosan from fungal origin was able to reduce the mean body weight up to 3 kg during the 90 day study period. Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. Additionally, there was also improvement in QoL score. It was safe and well tolerated by all subjects. Trial registration CTRI/2014/08/004901.

Three different bioadhesive gels were evaluated in a double-blind randomized clinical trial in which microbial growth in the suture thread was assessed following post-surgical application of the aforementioned gels. Also assessed in this trial were, the intensity of post-surgical pain as well as the degree of healing of the patients’ surgical wounds. A total of 21 patients (with 42 wisdom teeth) participated in this trial. Chlorhexidine gel, chlorhexidine-chitosan gel, and hyaluronic acid gel were evaluated, with a neutral water-based gel serving as the control agent. The aerobic and facultative anaerobic bacterial recovery on blood agar was lower in the placebo group than in the experimental groups. The most significant difference (p = 0.04) was observed in the chlorhexidine-chitosan group. in which the growth of Blood Agar and Mitis Salivarius Agar was significantly higher than in the placebo group. The intensity of post-surgical pain was very similar among all the groups. Significantly better healing rates were observed in the patients treated with chlorhexidine-chitosan gel when compared with those who used the placebo gel (p = 0.03), and in particular when compared with those patients who used hyaluronic acid gel (p = 0.01). Through our microbiological analyses, we were able to conclude that none of the bioadhesive gels tested resulted in beneficial reductions in the bacterial/fungal populations. However, the healing rates of patients who were treated with chlorhexidine-chitosan were better than those of the patients who used either the placebo gel or the hyaluronic acid gel.

Objective Weight is an influential factor in knee osteoarthritis (KOA). However, the effect of abnormal body weight on chitosan's efficacy in treating KOA is unclear. This study aimed to explore the differences in the effectiveness of arthroscopic surgery combined with intra‐articular chitosan injection for KOA in patients with abnormal body weight. Methods Patients with stage II‐III KOA (Kellgren–Lawrence rating, K‐L) undergoing arthroscopic surgery were recruited for this clinical study from January 2020 to September 2021. Based on body mass index (BMI) and intra‐articular chitosan injection, patients with KOA undergoing arthroscopic surgery (138 patients) were divided into four groups: low‐weight‐non‐injection (Lw‐N, BMI <18.5); low‐weight‐chitosan injection (Lw‐CS, BMI <18.5); overweight‐non‐injection (Ow‐N, BMI ≥25); overweight‐chitosan injection (Ow‐CS, BMI ≥25). A 2‐year follow‐up was conducted to evaluate various indicators, including the visual analogue scale (VAS) and the Western Ontario and McMaster Universities osteoarthritis index score (WOMAC). Statistical analyses were performed using relevant parametric or non‐parametric tests. Results In total, 138 patients with KOA were included in this study. There were no significant differences in gender, age, and incidence of chronic residual pain after arthroscopy among the four groups (p > 0.05). The proportion of patients undergoing subsequent knee arthroplasty during the 2‐year follow‐up period was significantly higher in the Ow‐CS group (20/35) than in the Lw‐CS group (12/39) (p < 0.05). The K‐L rating showed an overall increasing trend over time, with the K‐L rating in the Ow‐N and Ow‐CS groups significantly higher than that in the Lw‐CS group at the final follow‐up (p < 0.05). VAS and WOMAC scores significantly decreased at 1 and 3 months post‐arthroscopy and then increased. One month after arthroscopy, VAS was significantly lower (p < 0.05) in the intra‐articular chitosan injection groups (Lw‐CS and Ow‐CS) compared with the non‐injection groups (Lw‐N and Ow‐N). VAS was lower in the Ow‐CS group than in the Lw‐CS group (p < 0.05). There was no significant difference in WOMAC between the intra‐articular chitosan injection and non‐injection groups at each time point (Lw‐N vs. Lw‐CS, Ow‐N vs. Ow‐CS, p > 0.05). Conclusion Arthroscopic surgery combined with intra‐articular chitosan injection shows short‐term positive effects in treating KOA. Intra‐articular chitosan injection appears to have a greater short‐term pain relief effect in obese patients. This study aimed to explore the efficacy of arthroscopic surgery combined with chitosan injection for knee osteoarthritis in patients with abnormal body weight. Weight gain may accelerate the progression of knee osteoarthritis. Arthroscopic surgery combined with intra‐articular chitosan injection shows short‐term positive effects in treating knee osteoarthritis. Intra‐articular chitosan injection appears to have a greater short‐term pain relief effect in obese patients.