Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial.

BACKGROUND: Female sexual dysfunction (FSD) is a common complaint among postmenopausal women, which is largely because of the genitourinary syndrome in these women (GSM). AIM: Considering the phytoestrogenic effects of chamomile, the present study was primarily aimed to investigate the effect of chamomile vaginal gel on the sexual function of postmenopausal women. The side effects of these drugs were evaluated as a secondary outcome of the study. METHODS: This randomized double-blind clinical trial and placebo-controlled study was conducted on postmenopausal women with sexual dysfunction (FSFI ≤26.55). To this aim, 96 postmenopausal women were randomly assigned into three groups (n = 32 each) including women receiving (i) chamomile vaginal gel 5%, (ii) conjugated estrogen vaginal cream, and (iii) placebo vaginal gel, for 12 weeks (ie, every night in the first 2 weeks, and 2 nights per week in the next 10 weeks, each night 1 g was used). The sexual function was measured using female sexual function index (FSFI) before and after the intervention. Data analysis was performed by chi-square, one-way ANOVA, descriptive statistics, analysis of covariance (ANCOVA), and paired t test using SPSS software version 22. P < .05 was considered statistically significant. OUTCOMES: The main study outcome measure was evaluate the effects of vaginal administration of chamomile gel in comparison with conjugated estrogen cream and placebo gel on postmenopausal FSD using the FSFI. RESULTS: The findings showed that chamomile vaginal gel in compared to placebo vaginal gel caused a significant improvement in all six sexual function domains and the total FSFI score (effect size = +2.9 [95% CI, +2.1 to +3.6], P < .001). Also, there was no significant difference between the chamomile vaginal gel and conjugated estrogen vaginal cream groups in terms of the total score and all sub-domains of sexual function with the exception of orgasm (effect size = +0.13 [95% CI, -0.36 to +0.63], P = .02) and sexual satisfaction (effect size = 0 [95% CI, -0.49 to +0.49], P = .04). Two women in the chamomile group and one in the placebo group experienced a burning sensation (P = .345). CLINICAL IMPLICATIONS: This treatment can be considered as a treatment option for postmenopausal women with sexual dysfunction who have contraindications to the use of hormone therapy. STRENGTHS & LIMITATIONS: This study is the first study to investigate the effectiveness of chamomile vaginal gel on sexual function in postmenopausal women. However, in this study, treatment duration was 12 weeks and no follow up was performed beyond this time CONCLUSION: Based on the results of this study, the use of vaginal chamomile gel improved sexual function in postmenopausal women. Bosak Z, Iravani M, Moghimipour E, et al. Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial. J Sex Med 2022;19:983-994.

PHBV/PLGA nanoparticles for enhanced delivery of 5-fluorouracil as promising treatment of colon cancer.

5-Fluorouracil (5-FU) is one of the most widely used agents in the first-line chemotherapy for colon cancer. However, clinical use of 5-FU is limited because of the low efficacy of drug uptake and systemic toxic effects. Therefore, there is a critical need to find better drug delivery systems in order to improve the efficacy of the drug. In the present study, we have developed a novel combination drug delivery system based on PHBV/PLGA NPs for delivery of 5-FU to cancer cells. NPs were prepared by the double emulsion method and their optimization of preparation was evaluated using Box-Behnken design (BBD) of response surface methodology (RSM). 5-FU loaded NPs were characterized by scanning electron microscope (SEM), differential scanning calorimetry (DSC), thermogravimetry analysis (TGA), and Fourier transformed infra-red spectroscopy (FT-IR). SEM image implied that NPs were spherical in shape and the results of DSC, TGA, and FT-IR suggest that 5-FU was encapsulated into NPs. The obtained results revealed that 5-FU loaded PHBV/PLGA NPs induced significant higher cell death at concentration much lower than free 5-FU. Results of hemolysis assay indicated that the NPs were hemo-compatible. In vivo anti-tumor studies showed that 5-FU loaded NPs reduced tumor volume significantly in comparison with free 5-FU. As the first example of using PHBV/PLGA as nano-drug delivery system with enhanced anti-tumor activities, this study establishes PHBV/PLGA as a novel promising drug delivery platform for treatment of colon cancer.

Application of polycaprolactone, chitosan, and collagen composite as a nanofibrous mat loaded with silver sulfadiazine and growth factors for wound dressing.

Fabrication of nanofibrous biomaterials composed of natural and synthetic materials that incorporated with antibiotic and growth factors with controlled release manner is an attractive topic in wound healing. The purpose of this study was to prepare optimal composite of materials as biomimetic nanofibrous mats for application in wound healing. The mat was prepared of polycaprolactone (PCL) in the bottom, chitosan/poly ethylene oxide (Cs/PEO) in the middle, and PCL/collagen (PCL/Coll) in the top layer. A panel of standard characterization tests of nanofibrous mat was performed and its compatibilities in strength and integration were confirmed. Middle layer was loaded with epidermal growth factor (EGF) and basic fibroblast growth factor (bFGF), and silver sulfadiazine (SSD) was incorporated in the bottom layer as an anti-infection factor. Then, on the dorsum of rats, a 400-mm2 wound was created and surrounded by a silicone ring to control the usual tissue contractions. Nanofibrous mats with or without growth factors were applied as wound dressings and at day 14, the healing process was evaluated. At day 14, the treated group by designed mat showed faster epithelialization and angiogenesis. Silicone ring in the test group was desirable in wound closure compared to the control group. Reformation of skin tissue was manifested in a shorter time. This composite nanofibrous mat could be introduced as a dynamic and effective candidate for wound dressing.

Effects of coating layer and release medium on release profile from coated capsules with Eudragit FS 30D: an in vitro and in vivo study.

The aim of the present research was to evaluate the impact of coating layers on release profile from enteric coated dosage forms. Capsules were coated with Eudragit FS 30D using dipping method. The drug profile was evaluated in both phosphate buffer and Hank's solutions. Utilization X-ray imaging, gastrointestinal transmission of enteric coated capsules was traced in rats. According to the results, no release of the drug was found at pH 1.2, and the extent of release drug in pH 6.8 medium was decreased by adding the coating layers. The results indicated single-layer coated capsules in phosphate buffer were significantly higher than that in Hank's solution. However, no significant difference was observed from capsules with three coating layers in two different dissolution media. X-ray imaging showed that enteric coated capsules were intact in the stomach and in the small intestine, while disintegrated in the colon.

A mechanistic study of the effect of transferrin conjugation on cytotoxicity of targeted liposomes.

This study was performed to prepare 5-fluorouracil (5FU) containing targeted liposomes for the safety and efficacy enhancement. Liposomes were prepared using thin layer method and transferrin (Tf) was employed as the targeting ligand. Morphology of 5FU-loaded liposomes was assessed by transmission electron microscopy (TEM). The in vitro cytotoxicity was investigated via MTT assay on HT-29, CT26 and fibroblast cells. Mitochondrial membrane and cell death evaluations were also investigated. Resulted showed that the encapsulation efficiency (EE%) and particle size of the liposomes were 40.12% and 130 nm, respectively. TEM image implied that liposomes were spherical in shape. In cancer cells, targeted liposomes triggered the mitochondrial apoptotic pathway by lower production of reactive oxygen species (ROS) (63.58 vs 84.95 fluorescence intensity), reduced mitochondrial membrane potential and releasing of cytochrome c (68.66 vs 51.13 ng/mL). The results of this study indicated that Tf-targeted 5FU liposomes can be employed as promising nanocarrier for the delivery of drugs to cancer cells.

Sonic hedgehog pathway suppression and reactivation accelerates differentiation of rat adipose-derived mesenchymal stromal cells toward insulin-producing cells.

BACKGROUND AIMS: Sonic hedgehog (Shh) is an intercellular signaling molecule that regulates pancreas development in mammals. Manipulation of Shh signaling pathway can be used as reliable approach to improve the generation of functional insulin-producing cells (IPCs) from mesenchymal stromal cells (MSCs). METHODS: In the present study, a novel differentiation protocol was used to produce IPCs from adipose tissue-derived MSCs (ATDMSCs) based on sequential inhibition and reactivation of Shh pathway. ATDMSCs were differentiated into IPCs via a 14-day basic protocol using 1% insulin transferrin selenium (ITS) and 1% nicotinamide in Dulbecco's Modified Eagle's Medium medium. A mixture of 0.25 µmol/L cyclopamine + 64 ng/mL basic fibroblast growth factor at day 3 of differentiation and 150 ng/mL recombinant Shh at day 11 of differentiation were used, respectively, to promote sequential inhibition and reactivation of Shh pathway. Insulin granule formation, glucose-stimulated insulin secretion and gene expression pattern related to the pancreatic endocrine development and function were analyzed in manipulated and unmanipulated IPCs. RESULTS: IPCs obtained after Shh manipulation secreted higher amounts of insulin in vitro. This phenotype was accompanied by increased expression of both genes critical for ß-cell function and transcription factors associated with their mature phenotype including Pdx1, MafA, Nkx2.2, Nkx6.1, Ngn3, Isl1 and insulin at day 14 of differentiation. CONCLUSIONS: Our findings indicated that the early inhibition and late reactivation of Shh signaling pathway during the differentiation of ATDMSCs improved the functional properties of IPCs, a novel method that could be considered as an alternative approach for cell-based therapy for type 1 diabetes.

Absorption-Enhancing Effects of Bile Salts.

Bile salts are ionic amphiphilic compounds with a steroid skeleton. Among the most important physiological properties of bile salts are lipid transport by solubilization and transport of some drugs through hydrophobic barriers. Bile salts have been extensively studied to enhance transepithelial permeability for different marker molecules and drugs. They readily agglomerate at concentrations above their critical micelle concentration (CMC). The mechanism of absorption enhancement by bile salts appears to be complex. The aim of the present article was to review bile salt structure and their application as absorption enhancers and the probable mechanism for increasing permeation based on previous studies.

Functionalized liposomes as a potential drug delivery systems for colon cancer treatment: A systematic review.

Colon cancer is one of the lethal diseases in the world with approximately 700,000 fatalities annually. Nowadays, due to the side effects of existing methods in the treatment of colon cancer such as radiotherapy and chemotherapy, the use of targeted nanocarriers in cancer treatment has received wide attention, and among them, especially liposomes have been studied a lot. Based on this, anti-tumor drugs hidden in targeted active liposomes can selectively act on cancer cells. In this systematic review, the use of various ligands such as folic acid, transferrin, aptamer, hyaluronic acid and cRGD for active targeting of liposomes to achieve improved drug delivery to colon cancer cells has been reviewed. The original articles published in English in the databases of Science Direct, PubMed and Google scholar from 2012 to 2022 were reviewed. From the total of 26,256 published articles, 19 studies met the inclusion criteria. The results of in vitro and in vivo studies have revealed that targeted liposomes lead to increasing the efficacy of anti-cancer agents on colon cancer cells with reducing side effects compared to free drugs and non-targeted liposomes. To the best of our knowledge, this is the first systematic review showing promising results for improvement treatment of colon cancer using targeted liposomes.

Clinical evaluation of liposome-based gel formulation containing glycolic acid for the treatment of photodamaged skin.

Background: Long contact of UV causes skin damage. Glycolic acid (GA) as an alpha hydroxy acid is used to treat photodamaged skin. However, GA leads to side effects including; burning, erythema and peeling.Purpose: The aim of this study was to develop a controlled delivery systems loading GA in order to increasing its efficacy and lowering its side effects.Methods: Liposomes were evaluated for encapsulation efficiency, size and morphology. Optimized formulation was dispersed in HPMC gel bases and drug release kinetics were also studied. Clinical efficacy and safety of GA-loaded liposomal gel and GA gel formulation were evaluated in patients with photodamaged skin.Results: The EE% and average particle size of liposomes were 64 ±2.1 % and 317±3.6 nm, respectively. SEM image showed that liposomes were spherical in shape. In vitro release kinetics of GA from both formulations followed Weibull model. Clinical evaluation revealed that GA-loaded liposomal gel was more effective than GA gel formulation. Treatment with GA-loaded liposomal gel resulted in a statistically significant reduction in the scores of hyperpigmentation, fine wrinkling and lentigines. Moreover, liposomal gel formulation was able to minimize side effects of GA.Conclusion: According to the obtained results, the liposome-based gel formulation can be used as potential drug delivery system to enhance permeation of GA through skin layers and also reduce its side effects.

The potent in vitro skin permeation of archaeosome made from lipids extracted of Sulfolobus acidocaldarius.

Archaeosomes are a new generation of liposomes that exhibit higher stabilities under different conditions, such as high temperatures, alkaline or acidic pH, and presence of bile salts in comparison with liposomes, and can be used in biotechnology including drug, gene, and vaccine delivery. The objective of this study was to prepare archaeosomes using lipid extracted from Sulfolobus acidocaldarius and evaluate their physicochemical properties. The lipids were extracted from S. acidocaldarius and assayed by High Performance Thin-Layer Chromatography (HPTLC). Archaeosomes were prepared using film method and methylene blue was used as drug model. They were characterized for their vesicle size and Differential Scanning Calorimetry (DSC) was used to investigate changes in their thermal behavior. The released amount of methylene blue was determined using a dialysis membrane and rat skin. HPTLC analysis of the extracted lipids showed that glycerol ether may be the major lipid with more than 78 percent probability. Results of particle size determination showed a mean size of 158.33 nm and the results of DSC indicated the possible interaction of methylene blue with lipids during the preparation of archaeosome. The addition of cholesterol significantly improved the encapsulation of methylene blue in the archaeosome so that the encapsulation efficiency was 61.66 ± 2.88%. The result of in vitro skin permeation showed that methylene blue could pass through skin model according to Peppas model and there was about 41.66% release after 6 h, whereas no release was observed through dialysis membrane. According to the results of the study, it is concluded that archaeosome may be successfully used as drug delivery system.

Cellulose derivatives and natural gums as gelling agents for preparation of emulgel-based dosage forms: A brief review.

Incorporation of an emulsion onto a gel base develops a drug delivery system with improved characteristics, known as emulgel, that can envelop both hydrophilic and lipophilic molecules, and therefore increase stability and penetration of topical formulations. Such a drug delivery system provides controlled drug release that has more patient compliance and higher therapeutic efficacy. Emulgel is prepared in three main stages, preparation of water-in-oil or oil-in-water emulsion, providing the gel base, and incorporation of prepared emulsion onto gel base with continuous stirring. Various materials such as different oils (e.g. sesame oil, balsam oil, and mineral oil), emulsifiers (e.g. Tween® and Span® as the non-ionic surfactant, polyvinyl alcohol), and gelling agents including cellulose derivatives such as hydroxypropyl methylcellulose (HPMC), hydroxyethylcellulose (HEC) and carboxymethyl cellulose (CMC) in different concentrations are used in emulgel preparation. The physical properties, particle size distribution, spreadability, permeation, and drug release rate are evaluated in their development and characterization. They are used in skin disorders and other diseases such as chronic anal fisher. Also, anti-acne, analgesic, and anti-inflammatory drugs have been formulated as emulgel delivery system and their effects have been studied. In this article, the subject is to review the characteristics, preparation methods, and therapeutic efficacy as well as the potential clinical use of emulgels.

Ocular Delivery of Quercetin Using Microemulsion System: Design, Characterization, and Ex-vivo Transcorneal Permeation.

Background: The goal of this research was to design and characterize quercetin microemulsions (MEs) to resolve water solubility issues related to quercetin and improve transcorneal permeation into the eye. Methods: MEs were prepared by the phase diagram method. Oily phase (oleic acid-Transcutol P), surfactant (Tween 80, Span 20), and co-surfactant (propylene glycol) were used to make a quercetin-loaded ME. The size of the droplets, their viscosity, pH, release, flux, and diffusivity were all measured. Results: Droplet diameters in ME samples ranged from 5.31 to 26.07 nanometers. The pH varied from 5.22 to 6.20, and the release test revealed that 98.06 percent of the medication was released during the first 24 hours. The flux and diffusivity coefficients of the ME-QU-8 formulation were 58.8 µg/cm2.h and 0.009 cm2/h, respectively, which were 8.8 and 17.9 times greater than the quercetin aqueous control (0.2 percent). The maximum percentage of drug permeated through rabbit cornea after five hours was 16.11%. Conclusions: It is concluded that ME containing quercetin could increase transcorneal permeation and that permeation could be altered by any change in the composition of the ME formulation. This effect might be caused by structural alterations in the cornea caused by ME components.

Effect of postbiotic-toothpaste on salivary levels of IgA in 6- to 12-year-old children: Study protocol for a randomized triple-blind placebo-controlled trial.

Background: Children in mixed dentition are highly at risk for dental caries, which is a major health issue worldwide. Despite their effect in controlling dental caries, using probiotics can be challenging. Therefore, it has been advised to use their inanimate forms, called postbiotics. We hypothesize that postbiotics can enhance the oral immunity. Methods: The aim of this triple-blind, randomized, placebo-controlled trial is to investigate the effect of postbiotic-toothpaste (Bifidobacterium animalis subsp. animalis) on salivary levels of Immunoglobulin A (IgA) and pH in children. Using comparing two means formula to calculate the sample size, for this trial 80 healthy 6- to 12-year-old children during mixed dentition with no cavitated dental caries will be selected by convenience sampling method and randomly allocated to two groups, postbiotic-toothpaste or placebo-toothpaste. Saliva samples will be gathered at baseline and four weeks after the intervention. The level of salivary IgA will be determined by ELISA and salivary pH will be measured using a pH meter. Data will be compared within and between groups using independent t-test and paired t-test, in case of normality, with a p < 0.05 as statistically significant. Discussion: If postbiotics-toothpaste prove to be effective in improving the oral immunity, they can be used to prevent dental caries and other oral diseases. The result of this study can help researchers who are working on the immunomodulatory effects of postbiotics in children. Trial registration number: Iranian Registry of Clinical Trials (IRCT), IRCT20191016045128N2. Registered on 7 March 2022.

Preparation and evaluation of a free surfactant herbal shampoo with Acanthophyllum Squarrosum Saponins.

BACKGROUND: Shampoos remove fat and pus from the skin and hair. The most critical part of these products is their cleansing properties; therefore, the amount of shampoo cleanser plays an essential role in consumer acceptance. AIM: The production of herbal shampoos from root saponins in Hawthorn can lead to the removal of these substances from shampoos. Squarrosum is one of the 23 Acanthophyllum species that is native to Iran. The root of this plant has been used traditionally as a consumption detergent due to the presence of saponins. METHOD: To make the shampoo, saponins were extracted through several steps by a solvent after Acanthophyllum squarrosum scientific specimens had been prepared and identified The shampoo's fatigue strength was tested using the Ross-Miles method, and its cleansing power was assessed using Thompson's test. RESULTS: The optimum formula with 15% total saponins content was evaluated. CONCLUSION: This liquid shampoo has an excellent cleansing effect, is suitable for regular hair; has pseudoplastic rheology; and has acceptable pH, surface tension, and organoleptic stability characteristics.

Bacteria and Archaea: A new era of cancer therapy.

Cancer is one of the most important mortality in the world. The major drawbacks of chemotherapy are the poor absorption of drugs into tumor tissues and development of resistance against anti-cancer agents. To overcome these limitations, the use of microorganisms has been extensively considered in the treatment of cancer. Microorganisms (bacteria/Archaea) secrete different bioactive compounds that can efficiently inhibit cancer cells growth. Biological nanocarriers derived from microorganisms including outer membrane vesicles (OMVs), bacterial ghosts (BGs) and archaeosomes have also been considered as drug delivery systems. Conjugation of drug loaded nanocarriers to bacteria strongly kills the cancer cells after internalization through the bacteria. Merging of microbiology and nanotechnology may provide versatile microbial nano-hybrids for promising treatment of cancer. This strategy causes more amount of drug to enter into cancer cells. In this review, we present evidence that microorganism, their derivatives as well as their intervention with nanotechnology can be a powerful vehicle for eradication cancer.

Comparison of the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of vulvovaginal candidiasis.

Candidal vaginitis has a relatively high prevalence, and its resistance to treatment is on the rise. Considering the complications of chemical drugs, the use of herbal medicines has now been favored due to the lack of changes in the normal vaginal flora. The aim of this study was to compare the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of candidal vulvovaginitis. A randomized clinical trial was conducted on 84 reproductive-aged women in the city of Ahvaz, Iran. Individuals were randomly divided into two treatment groups: 1% Satureja khuzestanica vaginal creams (n=42) and 1% clotrimazole vaginal cream (n=42) who used a one-full applicator daily for one week. About 4-7 days after the end of treatment, a clinical examination and laboratory re-tests were performed to determine the level of treatment. The data were analyzed using the Mann-Whitney U, t-test and Chi-square tests, with SPSS version 22. After the treatment, no significant difference was observed between the two groups in terms of vaginal discharge (p = 0.32), vaginal itching (p = 0.26), dysuria (p = 0.99) and dyspareunia (p = 0.60). Moreover, the results of culture (p = 0.62) and smear (p = 0.58) were not statistically significant in the two groups. Also, there was no significant difference between the two groups in terms of complete recovery after the treatment (p = 0.35). Satureja khuzestanica seems to have the same effect as clotrimazole in improving the symptoms of vaginal candidiasis, the negative results of culture and smear, as well as complete treatment.

Correction to: Comparison of the effectiveness of Satureja khuzestanica and clotrimazole vaginal creams for the treatment of vulvovaginal candidiasis.

[This corrects the article on p. 111 in vol. 14, PMID: 33767795.].

Evaluation of Wound Healing Activity of Sea Cucumber Holothuria parva Hydroalcoholic Extract in Rat.

A significant challenge in biomedicine is the development of Biomaterials with the potential to accelerate wound healing. The aim of this study was to investigate the effect of the gel prepared from sea cucumber on wound healing in rats. Full-thickness wounds were created in male rats divided into five experimental groups, negative control (NC), positive control (PC), and treatments. The NC and PC groups received respectively gel base and phenytoin cream 1%. Treatment groups were treated topically by gels of 1%, 3%, and 5% Holothuria parva extract (HPE) in the gel base. The rats were sacrificed on days 7, 14, and 21. Pathological reports revealed the proliferation of keratinocytes in the borders of the wound in treatment groups and controls. Formation of granulation tissue was seen on day 7 in treatment groups, collagen fibers in granulation tissue were randomly organized, and the rate of fibroblast decreased. Results showed that there were statistically significant differences in wound contraction between all groups in comparison to the NC group (P < .05) on day 8. It was concluded that the 1% HPE gel has a good potential for promoting wound healing. [Formula: see text].

Evaluation of the influence of chamomile vaginal gel on dyspareunia and sexual satisfaction in postmenopausal women: A randomized, double-blind, controlled clinical trial.

OBJECTIVE: The purpose of this study was to determine the effect of chamomile vaginal gel on dyspareunia and sexual satisfaction in postmenopausal women. The phytoestrogenic properties of Matricaria chamomilla were the reason for selection of this plant. MATERIALS AND METHODS: This double-blind clinical trial research was conducted on 96 eligible postmenopausal women referring to Gotvand city Health Center No. 1 in 2018. In this research, 96 postmenopausal women complaining from dyspareunia and sexual dissatisfaction were randomly assigned into three groups (each contained 32 subjects) to receive 5% chamomile vaginal gel, conjugated estrogen vaginal cream and placebo gel, for 12 weeks. All women completed the Larsson and a four-degree pain self-assessment questionnaires. Data was analyzed using SPSS version 22. A p-value of less than 0.05 was considered significant. RESULTS: After the intervention period, a significant difference was seen between the intervention and the placebo group in the mean sexual satisfaction (p<0.001). Also, a significant reduction was seen in painful sexual intercourse between the groups using vaginal gel of chamomile and conjugated estrogen vaginal cream (95% CI: chamomile: 0.68-1.04, estrogen: 0.63-0.98, placebo: 1.8-2.1; p<0.001). CONCLUSION: Using chamomile vaginal gel can cause a reduction in painful sexual intercourse and an increase in sexual satisfaction in postmenopausal women.

Protective effect of gallic acid and gallic acid-loaded Eudragit-RS 100 nanoparticles on cisplatin-induced mitochondrial dysfunction and inflammation in rat kidney.

Cisplatin is used as a chemotherapy drug in the treatment of various types of cancer. Mitochondrial dysfunction, oxidative stress and inflammation have been identified as major mechanisms of cisplatin nephrotoxicity. The present study investigated the protective effects of pure gallic acid and nanoparticle gallic acid nanoparticles (nano-gallic acid) on cisplatin induced nephrotoxicity. Nano-gallic acid was prepared by double emulsions-solvent evaporation technique using Eudragit RS 100 polymer and polyvinyl alcohol as carrier. Then, the physicochemical characterization of the nanoparticles was examined. In the present study, renal mitochondria were isolated using different centrifugal methods. Our data indicated that the doses of 50 and 100 mg/kg gallic acid and 10 mg/kg nano-gallic acid significantly decreased mitochondrial reactive oxygen species (ROS) formation, mitochondrial membrane damage (ΔΨm), mitochondrial malondialdehyde (MDA), tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6) and significantly increased mitochondrial glutathione (GSH), mitochondrial superoxide dismutase (MnSOD), mitochondrial glutathione peroxidase (GPX) and mitochondrial catalase compared to the cisplatin treated group. Histopathological studies also confirmed biochemical tests. Finally, our results confirmed that the pure gallic acid and its nanoparticle improved renal oxidative stress, inflammation and mitochondrial dysfunction in acute nephrotoxicity induced by cisplatin in rat. Nano-gallic acid (10 mg/kg) was selected as the most effective dose. The findings of this study showed the superiority of nano-gallic acid against pure gallic acid. In conclusion, nano-gallic acid-loaded Eudragit-RS 100 as a novel antioxidant can be considered in the treatment of renal complications of cisplatin.