scholarly journals A randomized comparison study of conventional normal saline and silver nanocrystalline gel as topical wound dressings in non-healing wounds

2021 ◽  
Vol 8 (10) ◽  
pp. 3050
Author(s):  
V. Mahadev
Keyword(s):  
Normal Saline ◽  
Primary Outcome ◽  
Statistical Significance ◽  
Healing Process ◽  
Randomized Study ◽  
Wound Dressings ◽  
Secondary Outcome ◽  
Open Label ◽  
Chronic Ulcers ◽  
Healing Wounds

Background: Non-healing wounds and chronic ulcers are being consequence of the abnormality in healing process and disturbance in the recovery pathway. Picking an ideal choice of topical application and dressing helps in enhancing the wound heal in addition to the antibiotics administration. To identify the outcome of topical dressing in chronic ulcers by using, silver nanocrystalline gel dressing (AgNP) and conventional normal saline dressing (NS).Methods: This study was an open label randomized study in patient with chronic non-healing wound. The wound healing outcomes of two different dressing methods were compared, which was evaluated by independent assessor. The primary outcome is area reduction of wound and duration of healing. The secondary outcome is the formation of healthy granulation, slough and discharge and wound site infection control.Results: The outcome of AgNP and conventional NS dressing was compared. The 100 patients with non-healing wounds were randomized in the ratio of 1:1. The primary outcome was study group had better area of reduction of 41.97% (SD-7.41) with statistical significance (p<0.0001) and mean duration of healing, 15.64 weeks. The secondary outcome of healthy granulation tissue and reduced slough and discharge at the end of 3 weeks with topical silver nanocrystalline dressing was significant.        Conclusions: Topical silver nanocrystalline dressing shall be an effective dressing option to achieve apposite recovery of healing process in non-healing wounds.        

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

P–328 Dienogest significantly decreases the size of the cyst and alters Anti-Müllerian Hormone concentration in patients with endometrioma

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
E Karataş ◽  
B E Temiz ◽  
S Mumusoglu ◽  
H Yarali ◽  
G Bozdag
Keyword(s):  
Primary Outcome ◽  
Statistical Significance ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Control Group ◽  
Significant Drop ◽  
Mean Size ◽  
The Mean ◽  
Respective Figure

Abstract Study question Does utilization of dienogest make any impact on the size of cyst and Anti-Müllerian Hormone (AMH) concentration in patients with endometrioma throughout 12-months? Summary answer Although dienogest makes a gradual reduction in the size of endometrioma cyst throughout 12-months, a significant drop in AMH serum concentration was also noticed. What is known already According to recent studies, pre-operative serum AMH levels might be illusively increased with parallel to the size of endometrioma which will be a misleading factor while deciding to operate the patient via cystectomy. Although dienogest is one of the medical options that might be commenced in patients with endometrioma cyst, there is limited data about its effect on the size of the endometrioma and hence serum AMH concentration throughout 12 months of follow up. Study design, size, duration The current observational cohort study was conducted among patients with endometrioma those treated with dienogest from January 2017 to January 2020. The primary outcome was alteration in diameter of endometrioma cyst at 6th and 12th months of treatment. Secondary outcome was alteration in serum AMH concentration in the same period. Of 104 patients treated with dienogest, 44 patients were excluded due to being treated with any type of surgical intervention during follow up period. Participants/materials, setting, methods A total of 60 patients were recruited for the final analysis. Of them, primary symptom was dysmenorrhea, chronic pelvic pain and menstrual irregularity in 16 (26.7%), 25 (41.7%) and 8 (13.3%) patients, respectively. Eighteen patients (30%) were asymptomatic. As 21 patients had bi-lateral endometrioma, size of the leading cyst was considered to be analyzed for the primary outcome measure. Paired-t test was used for comparison of numerical values and p ≤ 0.05 was taken as statistical significance. Main results and the role of chance The mean age was 31.5±8.0 years. In the time point when dienogest was started, the mean size of the endometrioma was 46.3±17.4 mm. The mean serum AMH concentration was 3.6±2.4 ng/ml. After 6 months of treatment, the mean size of the endometrioma decreased to 38.6±14.0 mm which corresponds to a mean difference of 7.8 mm (95% CI: 3.0 to 12.6; p: 0.003). The respective figure for AMH was 3.3±2.7 ng/ml which corresponds to a mean difference of 0.3 ng/ml (95% CI: –0.2 to 0.8; p: 0.23) at 6 months. After 12 months of treatment, the mean size of the endometrioma was 37.5±15.7 mm which corresponds to a mean difference of 8.9 mm (95% CI: 2.9 to 14.9; p: 0.005) at the end of 12 months. The respective figure for AMH was 2.7±1.9 ng/ml which corresponds to a mean difference of 0.9 ng/ml (95% CI: 0.1 to 1.7; p: 0.045) at the end of 12 months. The mean diameter of endometrioma and AMH concentration did not differ throughout the time period between 6th and 12th months of the treatment. Limitations, reasons for caution Although herein we present the largest data that depicts the alteration of endometrioma cyst and AMH concentration with the application of dienogest, the lack of control group is a limitation that avoids to perform any comparison. Wider implications of the findings: A shrinkage after commencement of treatment suggest that dienogest might present improvement in patients with endometrioma with respect to radiological findings, but further studies are required whether a decline in AMH concentration after 12 months refers to a genuine decrease in ovarian reserve or resolution of misleading high pre-treatment levels. Trial registration number not available

The Efficacy of Five Different Wound Dressings on Some Histological Parameters in Children With Partial-Thickness Burns

2020 ◽  
Vol 41 (6) ◽  
pp. 1179-1187 ◽  
Author(s):  
Birsen Harma ◽  
Mehmet Gül ◽  
Mehmet Demircan
Keyword(s):  
Stratum Corneum ◽  
Gold Standard ◽  
Statistical Significance ◽  
Healing Process ◽  
Total Body Surface Area ◽  
Wound Dressings ◽  
Control Group ◽  
Burn Wounds ◽  
Partial Thickness ◽  
Partial Thickness Burns

Abstract An ideal dressing should ensure that the wound remains moist with exudates but not macerated. Currently, there is no dressing available to suit all wounds, at all stages of the healing process. Although silver-containing dressings are the gold standard for burn wound care, few high-level trials have been completed comparing the clinical utilities of these dressings. In our study, five different types of wound dressings: carboxymethyl cellulose hydrofiber dressing with ionized silver (CMCH-Ag), polyethylene-polyethylene terephthalate aqua fiber dressing with elementary silver (PPAF-Ag), calcium alginate (CA), calcium + zinc alginate (CZA), and 0.2% nitrofurazone-embedded (NF) gauze dressings were compared in regard to histopathological parameters. Children aged between 0 and 18 years with small or middle-sized partial-thickness burns that affected less than 30% of the total body surface area were included in this study. The study groups (CMCH-Ag, PPAF-Ag, CA, and CZA) and the control group (NF) were randomly attained. Wound healing was evaluated by punch biopsies on the 21st day. The thickness of the stratum corneum and the epithelium, the number of papillae, and the papillary length were calculated and compared. The histological parameters of healing, except the stratum corneum thickness, did not show any statistical significance among the groups (P &gt; .05). The dressings that included silver, calcium, or zinc showed useful and similar effects in noninfective burn wounds when compared with nitrofurazone-only dressings. Thus, it may be concluded that silver-containing wound dressings should not be considered as the gold standard in noninfective partial-thickness burn wounds in children.

scholarly journals Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

2006 ◽  
Vol 2006 ◽  
pp. 1-4 ◽  
Author(s):  
Ashwin J. Chatwani ◽  
Sarmina Hassan ◽  
Salma Rahimi ◽  
Stacey Jeronis ◽  
Vani Dandolu
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Change

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem.Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device.Results. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score.Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

scholarly journals Effect of Chloroethane Spray in the Treatment of Spastic Torticollis in Children and Adolescents

2015 ◽  
Vol 2 ◽  
pp. 2333794X1559156
Author(s):  
Kumara V. Nibhanipudi
Keyword(s):  
Emergency Room ◽  
Children And Adolescents ◽  
Normal Saline ◽  
Statistical Significance ◽  
Randomized Study ◽  
Pediatric Emergency ◽  
Spine Injury ◽  
P Value ◽  
City Hospital ◽  
Spastic Torticollis

Objective. A study to determine the efficacy of chloroethane spray compared to normal saline in the treatment of spastic torticollis in children and adolescents. Hypothesis. Chloroethane spray is more superior to normal saline for the treatment of spastic torticollis in children and adolescents in the pediatric emergency room. Design. Prospective randomized study. Setting. Urban inner-city hospital pediatric emergency department. Methods and Results. All children and adolescents (between the ages of 1 and 16 years) presenting to the author with the complaint of stiff neck were enrolled in the study. A total of 132 patients were enrolled. After complete evaluation to rule out cervical spine injury, a central neurological cause, patients were enrolled in the study. Sixty-six patients were treated with chloroethane spray to the neck and the other 66 were given normal saline as placebo. Sixty-three out of 66 patients treated with chloroethane spray achieved relief in 5 minutes as demonstrated by painless and free movement of the head and neck. No adverse effects were observed. The patients treated with placebo have no relief in 5 minutes. To test the null hypothesis that the percentages improved in the 2 groups equally, we calculated the Z statistic. The Z statistic of 24 corresponded to a P value of <.0001, whether the test is 1-sided or 2-sided. Chloroethane spray treatment was superior to placebo with a high statistical significance. Conclusion. For children and adolescents with spastic torticollis chloroethane spray was more superior to normal saline in the pediatric emergency room.

Effects of two instrument-generation changes on adenoma detection rate during screening colonoscopy: results from a prospective randomized comparative study

Endoscopy ◽  
2018 ◽  
Vol 50 (09) ◽  
pp. 878-885 ◽  
Author(s):  
Katharina Zimmermann-Fraedrich ◽  
Stefan Groth ◽  
Susanne Sehner ◽  
Stefan Schubert ◽  
Jens Aschenbeck ◽  
...  
Keyword(s):  
Private Practice ◽  
Detection Rate ◽  
Primary Outcome ◽  
Statistical Significance ◽  
Randomized Study ◽  
Comparative Trial ◽  
Adenoma Detection Rate ◽  
Screening Colonoscopy ◽  
Adenoma Detection ◽  
Multiple Imaging

Abstract Background Previous studies have shown that multiple colonoscope features have to be changed before an improvement in adenoma detection rate (ADR) becomes obvious, such as with changing from one instrument generation to the next but one. We wanted to evaluate whether such an effect can also be observed in a private-practice screening setting. Methods In a randomized study, we compared the latest generation colonoscopes from one company (Olympus Exera III, 190) with the next to last one (Olympus 165), including only patients presenting for screening colonoscopy. The primary outcome was ADR achieved with 190 colonoscopes (190-C) in comparison with 165 colonoscopes (165-C). Results 1221 patients (46.1 % men; mean age 62.2 years, standard deviation 6.6) were included (599 screened with the Olympus Exera III, 190). The ADR difference in favor of the 190-C instrument (32 % [95 % confidence interval (CI) 26 % to 39 %] vs. 28 % [95 %CI 22 % to 34 %] in the 165-C group) failed to reach statistical significance (P = 0.10); only the rate of small (< 5 mm) adenomas was significantly increased at 22.5 % (95 %CI 19 % to 26 %) vs. 15.6 % (95 %CI 13 % to 18 %; P = 0.002). Furthermore, significantly more adenomas were found in the 190-C group, with an adenoma rate (all adenomas/all patients) of 0.57 (95 %CI 0.53 to 0.61) vs. 0.47 (95 %CI 0.43 to 0.51; P < 0.001). Conclusions This randomized comparative trial in a private-practice screening setting only partially confirmed the results of prior studies that, with multiple imaging improvements achieved over two instrument generations, an increase in overall adenoma number becomes measurable.

A Multicenter, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Posaconazole Vs Fluconazole in the Prophylaxis of Invasive Fungal Infection in a Chinese Population

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4916-4916
Author(s):  
Shen Yang ◽  
Xiaojun Huang ◽  
Jianxiang Wang ◽  
Jie Jin ◽  
Jianda Hu ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Failure Rate ◽  
Invasive Fungal Infection ◽  
Conflicts Of Interest ◽  
Statistical Significance ◽  
Randomized Study ◽  
Treatment Phase ◽  
Clinical Failure ◽  
Open Label ◽  
Neutropenic Patients

Abstract Abstract 4916 Background Invasive fungal infection (IFI) is a common and fatal complication in neutropenic patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Methods In this multicenter, randomized study, we enrolled patients with persistent neutropenia resulting from chemotherapy for the treatment of AML and MDS. Prophylaxis with either posaconazole or fluconazole was given to the patients to compare the efficacy and safety of the 2 drugs. The treatment was given with each cycle of chemotherapy until the patient recovered from neutropenia and had complete remission, an IFI occurred, or until the patient had received a maximum of 12 weeks of treatment. The primary end point was the incidence of possible, proven, or probable diagnosis of IFI during the treatment phase in *the 2 groups; clinical failure rate, all-cause mortality, and time to first systemic antifungal treatment were secondary end points. Results A total of 252 patients were included in this study, and 7 patients were excluded due to withdrawal of informed consent or deviation of eligible criteria. Finally, 124 patients from the posaconazole group and 121 patients from the fluconazole group were included; and 234 patients (117 in each group) entered into statistical analysis, respectively. The incidence of proven, probable, and possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (P = 0.0114). The clinical failure rate was lower in the posaconazole group (31.6% [95% CI: 23.3–40.9], 37/117) than in the fluconazole group (41.88% [95% CI: 32.8–51.4], 49/117); however, statistical significance was not reached (P = 0.168). The patients receiving posaconazole had a later onset of first systematic antifungal therapy than those receiving fluconazole (P = 0.0139). The most common clinical adverse reactions were liver function abnormalities, with 11 cases (9.4%) in the posaconazole group and 6 cases (5.1%) in the fluconazole group (P = 0.221). Conclusions Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic patients with AML and MDS undergoing chemotherapy and is well tolerated during long-term use. (ClinicalTrials.gov number, NCT00811928) Disclosures: No relevant conflicts of interest to declare.

scholarly journals Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Andrew W. Zimmerman ◽  
Kanwaljit Singh ◽  
Susan L. Connors ◽  
Hua Liu ◽  
Anita A. Panjwani ◽  
...  
Keyword(s):  
Autism Spectrum Disorder ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Autism Spectrum ◽  
Secondary Outcome ◽  
Clinical Effects ◽  
Open Label ◽  
Children With Asd ◽  
Open Label Phase

Abstract Background Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD. Methods We conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3–12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD. Results Data from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen’s d 0.21; 95% CI − 0.46, 0.88 and 0.10; 95% CI − 0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen’s d − 0.96; 95% CI − 1.73, − 0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p < 0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell. Limitations The sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase. Conclusions SF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers’ assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures. Trial registration: This study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense.

FC13-11 - Effectiveness of mazindol in children with ADHD : open-label study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1892-1892 ◽  
Author(s):  
E. Konofal ◽  
M. Lecendreux ◽  
F. Kaguelidou ◽  
F. Mentré ◽  
C. Laouenan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Pulse Rate ◽  
Primary Outcome ◽  
Preliminary Investigation ◽  
Therapeutic Benefit ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Mazindol is a central nervous system stimulant, which blocks reuptake of dopamine and norepinephrine. Mazindol (1–6 mg/d) has previously been studied in the treatment of excessive daytime sleepiness with relative therapeutic benefit. Our hypothesis suggests that mazindol may be effective for the treatment of Attention Deficit Hyperactivity Disorder symptoms.Based on clinical assessments after oral administration of mazindol to 24 children (9–12 years) with ADHD (according to DSM-IVTR criteria), this open-label study evaluates the efficacy, safety and tolerability of mazindol (1 mg/d, 7 days). Safety evaluations included routine hematology, electrocardiograms, blood pressure, and pulse rate. Efficacy rating measurements included ADHD-RS score (primary outcome measure), CPRS-R:L, CGI-S and CGI-I (secondary outcome measures). This clinical trial reports data obtained from 21 boys (10 ± 1 years).Based on primary outcome (ADHD-RS), change in ADHD-RS mean total score after one week of mazindol was −24.6 (p < 0.0001) ; greater than a 90% improvement from baseline. Change in CPRS-R:L (80 items) mean total score after one week of mazindol was −55.5 (p < 0.0001); CGI-S after one week of mazindol was -3,02 (p< 0.01). Adverse events were mild to moderate in severity and decreased appetite, weight loss, headache, and abdominal pain were most common (95%).Changes in laboratory values, ECG, blood pressure, pulse rate and body weight were not clinically meaningful. Blood pressure and pulse rate were unchanged (p > 0.05) after one week of treatment.This preliminary investigation suggests that mazindol is still a new well-tolerated and active psychostimulant for the treatment of ADHD in children.

scholarly journals Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

10.2196/17117 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e17117 ◽  
Author(s):  
Shinobu Shimizu ◽  
Masahiro Iijima ◽  
Yuki Fukami ◽  
Natsuko Tamura ◽  
Masahiro Nakatochi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomized Study ◽  
Manual Muscle Testing ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Study Cohort ◽  
Efficacy And Safety ◽  
Open Label ◽  
Intravenous Immunoglobulin Therapy ◽  
Muscle Testing

Background Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy. Objective This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP. Methods The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement in functional outcome assessed using the adjusted Inflammatory Neuropathy Cause and Treatment Disability Scale score at 26, 38, or 52 weeks after the start of treatment with rituximab in patients with CIDP and anti-paranodal protein antibodies. Secondary outcome measures include grip strength, manual muscle testing sum scores, results of nerve conduction studies, and other functional scales. Results We plan to enroll 25 cases for the full analysis set. Recruitment is ongoing, with 14 patients enrolled as of January 2020. Enrollment will close in September 2020, and the study is planned to end in December 2021. Conclusions This randomized controlled trial will determine if rituximab is safe and effective in patients with anti-paranodal antibodies. An open-label study will provide additional data on the effects of rituximab in patients with antibody-negative CIDP. The results of the RECIPE trial are expected to provide evidence for the positioning of rituximab as a pathogenesis-based therapeutic for refractory CIDP. Trial Registration ClinicalTrials.gov NCT03864185, https://clinicaltrials.gov/ct2/show/NCT03864185 ; The Japan Registry of Clinical Trials jRCT2041180037, https://jrct.niph.go.jp/en-latest-detail/jRCT2041180037 International Registered Report Identifier (IRRID) DERR1-10.2196/17117

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