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Purpose: In the present study, biodegradable poly (3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanoparticles (NPs) containing insulin were loaded in sodium alginate/jeffamine (ALG/jeff) hydrogel for prolonged delivery of insulin. The main aim of this work was to fabricate an efficient insulin delivery system to improve patient adherence by decreasing the repetition of injections., Methods: Swelling and morphological properties and crosslinking efficiency of ALG/jeff hydrogel were assessed. The composite hydrogel was prepared by adding PHBV NPs to ALG/jeff hydrogel concurrently with crosslinking process. The morphology and loading capacity of composite hydrogel were analyzed., Results: Circular dichroism measurement demonstrated that insulin remains stable following fabrication process. The release profile exhibited 54.6 % insulin release from composite hydrogel within 31 days with minor initial burst release equated to nanoparticles and hydrogels. MTT cell viability analysis was performed by applying L-929 cell line and no cytotoxic effect was observed., Conclusions: Favorable results clearly introduced fabricated composite hydrogel as an excellent candidate for drug delivery systems and also paves the route for prolonged delivery systems of other proteins., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Background: Non-pharmacological strategies that have been proposed by complementary medical systems, can be effective in management of COVID-19., Methods: This study was designed as a three-arm, assessor-blinded, randomized controlled trial. A total of 139 hospitalized COVID-19 patients were randomly assigned into three groups: (1) acupuncture (ACUG), (2) cupping (CUPG), and (3) control (CTRG). All participants received conventional treatment. The primary study endpoint included changes in respiratory signs including oxygen saturation (SpO 2 ) and respiratory rate (RR). The secondary endpoints were COVID-19-related hospitalization duration and serious adverse events such as intensive care unit (ICU) admission, intubation or death, all up to day 30. Also, improvements in cough, dyspnea, chest tightness, oxygen demand, anorexia, headache, weakness, sore throat, and myalgia were evaluated., Results: Forty-two patients in ACUG, 44 patients in CUPG, and 42 patients in CTRG completed the trial. After 3 days, SpO 2 and RR improved significantly in CUPG and ACUG compared with CTRG (effect size: 8.49 (6.4 to 10.57) and 8.51 (6.67 to 10.34), respectively: p<0.001). Compared with CTRG, patients in CUPG and ACUG recovered faster (mean difference: 6.58 (4.8 to 8.35) and 9.16 (7.16 to 11.15), respectively) and except for two patients in ACUG who were admitted to ICU, none of patients in ACUG or CUPG needed ICU or intubation (p<0.001 in comparison to CTRG). Amelioration of clinical COVID-19 related symptoms reached a high level of statistical significance in CUPG and ACUG in comparison with CTRG (p<0.01)., Conclusion: Cupping and acupuncture are promising safe and effective therapies in management of COVID-19. Trial registration: This study was registered at Iranian Registry of Clinical Trials: IRCT20201127049504N1 (https://en.irct.ir/trial/52621)., (© 2022 Korea Institute of Oriental Medicine. Published by Elsevier B.V.)