Efficacy and Safety of Tetrahydrocurcuminoids for the Treatment of Canker Sore and Gingivitis

Background. Tetrahydrocurcuminoids (THCs) are among the major metabolites of curcuminoids with a higher bioavailability and physiological stability and exhibit a broad spectrum of therapeutic activities. The objective of this study was to evaluate the efficacy of THCs in patients suffering from canker sore and gingivitis designed as an exploratory clinical trial. Methods. This is an open label prospective pilot clinical trial carried out at two clinical centers: Noble Hospital, Pune, Maharashtra, and Sri Venkateshwara Hospital, Bangalore, Karnataka in India. Participants were assigned to 21 days of treatment with chewable oral THCs supplement. Patients were instructed to self-administer one chewable tablet containing 100 mg of THCs twice daily for up to 21 days. This clinical trial was registered at a public Clinical Trial Registry in India (http://www.ctri.nic.in). Thirty-one canker sore and twenty-nine gingivitis patients participated in this study. Body mass index, throat numbness/relief, Visual Analog Scale (VAS) pain score, canker sore lesions, gingival appearance, inflammation and bleeding were assessed before and after treatment, at 14 and 21 days. Vital signs and laboratory parameters were assessed for safety. Results. THCs treatment significantly reduced the reddening at the site, difficulty in chewing, swallowing, and VAS pain score in the canker sore patients. Further, both single and multiple lesions were completely healed. In gingivitis patients, gingival appearance, bleeding, and inflammation were significantly reduced. No adverse effects were observed during the study. Conclusion. Overall, the findings of this study show that supplementation of THCs for 21 days reduced the pain and prevented the progression of the disease in patients suffering from canker sore and gingivitis without adverse side effects.

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Bioequivalence of a Generic Nateglinide Formulation in Healthy Chinese Volunteers under Fasting and Fed Conditions: A Randomized, Open-Label, Double-Cycle, Double-Crossover Study

Pharmacology ◽

10.1159/000512851 ◽

2021 ◽

pp. 1-8

Author(s):

Ming Yu ◽

Xiaobin Li ◽

Hao Jin ◽

Lu Chen ◽

Nan Wang ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Vital Signs ◽

Reference Formulation ◽

Clinical Trial Registry ◽

Open Label ◽

Laboratory Test Results ◽

Liquid Chromatography Tandem Mass ◽

Healthy Chinese

Introduction: Nateglinide or N-(trans-4-isopropylcyclohexyl-1-carbonyl)-D-phenylalanine is a drug with a rapid hypoglycemic effect that is mainly used in the treatment of type 2 diabetes. Very few studies have assessed bioequivalence based on feeding status. This study aimed to assess the pharmacokinetic bioequivalence and safety of nateglinide-containing tablets (0.12 g) in healthy Chinese volunteers under fasting and fed conditions. Methods: The studies were performed in 2017–2018 in the Phase I Clinical Trial Ward of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China. Eligible Chinese volunteers received a single 0.12-g dose of the test or reference formulation, followed by a 7-day washout period and administration of the alternate formulation. Blood samples were collected at various time intervals, and plasma nateglinide concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Then, the adverse events, laboratory test results, vital signs, and physical exam findings were compared between the 2 groups. Results: The ratios of the geometric means of Cmax, AUC0-t, and AUC0-inf of the tested to reference preparations under fasting conditions were 105.03% (90% confidence interval [CI]: 99.53–110.83%), 104.02% (90% CI: 101.37–106.74%), and 104.04% (90% CI: 101.38–106.77%), respectively. The same ratios under fed conditions were 96.55% (90% CI: 85.80–108.65%), 103.08% (90% CI: 100.07–106.18%), and 103.07% (90% CI: 100.21–106.01%), respectively. The 90% CI values for Cmax, AUC0-t, and AUC0-inf fell within the accepted range of bioequivalence (80.00–125.0%). Common adverse events included hypoglycemia, heart rate increase, palpitation, sweating, dizziness, and diarrhea. Conclusions: The test formulation (0.12 g) met the CFDA’s regulatory definition for bioequivalence to the reference formulation. Both formulations were well tolerated by healthy Chinese subjects. Trial Registration: This trial has been registered in the Chinese Clinical trial registry (ChiCTR2000030694), March 10, 2020.

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Hibiscus sabdariffa tea affects diet-induced thermogenesis and subjective satiety responses in healthy men, but not in women: a randomized crossover trial

Applied Physiology Nutrition and Metabolism ◽

10.1139/apnm-2021-0051 ◽

2021 ◽

Author(s):

Natália Cristina de Faria ◽

Ana Paula da Costa Soares ◽

Guilherme Fonseca Graciano ◽

Maria Isabel Toulson Davisson Correia ◽

Magda Carvalho Pires ◽

...

Keyword(s):

Clinical Trial ◽

Food Intake ◽

Energy Expenditure ◽

Resting Energy Expenditure ◽

Hibiscus Sabdariffa ◽

Clinical Trial Registry ◽

Open Label ◽

Satiety Response ◽

Diet Induced Thermogenesis ◽

Desire To Eat

The aim of this study was to investigate the effect of Hibiscus sabdariffa tea on energy expenditure, satiety response and food intake. This is an open-label, crossover, randomized clinical trial (RBR-5HZ86T), including 21 subjects (11 women, 10 men). The individuals were evaluated at acute moments (fasting and after eating standardized breakfast accompanied by water or Hibiscus sabdariffa tea). Resting energy expenditure was measured by indirect calorimetry, subjective satiety responses were evaluated with a visual analogue scale and food intake was assessed by using food records. The volunteers who drank the Hibiscus sabdariffa tea had lower perception of hunger (p=0.002) and greater feeling of satiety (p=0.010) and fullness (p=0.009) compared to control. Men who ingested the Hibiscus sabdariffa tea had an increase in nitrogen energy expenditure (water: 1501±290.7kcal, Hibiscus sabdariffa tea: 1619±288.9kcal; p=0.029). In comparison to control, men presented less perception of hunger (p=0.003) and desire to eat (p=0.016), increased satiety (p=0.021) and fullness (p=0.010), and women oxidized more fat (p=0.034) when they drank Hibiscus sabdariffa tea. There was no difference between treatments regarding the energy and macronutrient intake from the first meal and throughout the day (p>0.050) for all participants. The Hibiscus sabdariffa tea only affected energy expenditure and satiety responses in men. Clinical trial registry: ReBEC Platform of the Brazilian Clinical Trials Registry - RBR-5HZ86T Novelty bullets • Hibiscus sabdariffa tea promoted an increase in energy expenditure and caused less perception of hunger/desire to eat in men. • Hibiscus sabdariffa tea intake increased postprandial fat oxidation in women.

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Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.1992.10.12.1963 ◽

1992 ◽

Vol 10 (12) ◽

pp. 1963-1968 ◽

Cited By ~ 21

Author(s):

F G LeVeque ◽

J B Parzuchowski ◽

G C Farinacci ◽

S W Redding ◽

B Rodu ◽

...

Keyword(s):

Film Coating ◽

Multicenter Trial ◽

Analog Scale ◽

Open Label ◽

Oral Ulcers ◽

Subjective Assessments ◽

Film Forming ◽

Before And After ◽

Vas Scores ◽

Oral Comfort

PURPOSE This open-label, multicenter trial evaluated the efficacy of a mucoadherent, anesthetic medication (MGI 209) for relief from painful oral ulcers associated with cytotoxic chemotherapy. PATIENTS AND METHODS Twenty-eight eligible cancer patients who had up to five discrete oral ulcers (total area < or = 5 cm2) completed this study. Mean age was 53.5 years (range, 21 to 81). Subjective assessments of oral discomfort before and after an orange juice pain challenge (OJPC), which was measured using a visual analog scale (VAS), and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at (1) baseline (before MGI 209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment. RESULTS Most subjects had low VAS scores (4 or less), which was indicative of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120, and 180 minutes after MGI 209 treatment, most subjects had high VAS scores before and after an OJPC compared with baseline scores, which was indicative of a substantial increase in oral comfort; these differences were statistically significant (P < .0001). Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7%, 90.3%, 79.6%, and 71.3% of the total amount applied, respectively. CONCLUSION Benzocaine hydrochloride in combination with the protective, mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage. MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain.

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Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs: A Nonrandomized Trial

10.21203/rs.3.rs-407301/v1 ◽

2021 ◽

Author(s):

Pui Lun Alan TAI ◽

Kwok Wai Way LAU

Keyword(s):

Clinical Trial ◽

Special Needs ◽

Scientific Evidence ◽

Intervention Group ◽

Control Group ◽

Clinical Trial Registry ◽

Open Label ◽

Post Intervention ◽

Educational Kinesiology ◽

Registration Number

Abstract Although educational kinesiology is a popular intervention aims to improve brain functioning via physical movements, it lacks supporting scientific evidence. This study explores the effect of educational kinesiology on the changes in stress and anxiety markers in kindergarteners with special needs using psychometrics and biological measures. This open label non-randomized clinical trial was registered retrospectively in the Chinese Clinical Trial Registry (registration number: ChiCTR2000036305, url: http://www.chictr.org.cn/showproj.aspx?proj=58067, registration date: 22/08/2020). Thirty-seven kindergarteners with special needs (3.5-6.5 years old) were assigned to either the intervention group, which received one-hour educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC), salivary cortisol and oxytocin levels were obtained pre- and post-intervention. After controlling baseline, the changes in oxytocin levels remained significantly different between groups (F1,35 = 5.590, p = 0.020, eta2 = 0.145), but not in cortisol levels (F1,35 = 0.364, p = 0.550, eta2 = 0.01). PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (X2 = 4.367, p = 0.037, φ = 0.344, p = 0.037). Findings from both subjective and objective measures indicate a plausible anti-stress and anxiety effect in kindergarteners with special needs.

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Eye irrigation as a first-line treatment and diagnostic method for emergency department patients who complain of ocular foreign bodies

Scientific Reports ◽

10.1038/s41598-021-02989-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Hung-Da Chou ◽

Kuan-Jen Chen ◽

Eugene Yu-Chuan Kang ◽

Jui-Yen Lin ◽

Po-Han Yeh ◽

...

Keyword(s):

Emergency Department ◽

Pain Score ◽

Diagnostic Method ◽

Foreign Bodies ◽

Retention Rate ◽

First Line ◽

Ocular Pain ◽

Analog Scale ◽

Before And After ◽

Emergency Department Patients

AbstractThis prospective study aimed at determine whether eye irrigation removes ocular foreign bodies (FBs) and whether ocular pain predicts FBs. Emergency department patients complaining of ocular FBs were enrolled. In the irrigation group (n = 52), pain was evaluated with a visual analog scale before and after irrigation, and the presence of FBs was determined under a slit-lamp. In the nonirrigation group (n = 27), the evaluations were performed upon arrival. The corneal FB retention rate was found significantly lower in the irrigation (13/52, 25%) than in the nonirrigation groups (13/27, 48%; P = 0.04). After irrigation, those without FBs had more patients experiencing pain reduction (67%) compared to those with retained FBs (46%; P = 0.14) and had a greater magnitude of change in pain score (mean ± SD, − 2.6 ± 2.7 vs. − 0.7 ± 1.4; P = 0.02). An improvement in ocular pain score ≥ 5 points after irrigation predicted the absence of FBs with a negative predictive value of 100%. Eye irrigation significantly lowered corneal FB retention; if ocular pain decreased considerably, the probability of retained FBs was low, making irrigation-associated pain score reduction a feasible diagnostic method to exclude FB retention without needing specialized ophthalmic examinations.

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Clinical and immunological benefits of convalescent plasma therapy in severe COVID-19: insights from a single center open label randomised control trial

10.1101/2020.11.25.20237883 ◽

2020 ◽

Cited By ~ 1

Author(s):

Yogiraj Ray ◽

Shekhar Ranjan Paul ◽

Purbita Bandopadhyay ◽

Ranit D’Rozario ◽

Jafar Sarif ◽

...

Keyword(s):

Clinical Trial ◽

Passive Immunization ◽

Neutralizing Antibody ◽

Randomised Control Trial ◽

Single Center ◽

Clinical Trial Registry ◽

Open Label ◽

Plasma Therapy ◽

Clinical Trial Registration ◽

Clinical Benefits

AbstractIntroductionA single center open label phase II randomised control trial was done to assess the pathogen and host-intrinsic factors influencing clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT), in addition to standard of care (SOC) therapy in severe COVID-19 patients, as compared to patients only on SOC therapy.MethodsConvalescent plasma was collected from patients recovered from COVID-19 following a screening protocol which also included measuring plasma anti SARS-CoV2 spike IgG content. Retrospectively, neutralizing antibody content was measured and proteome was characterized by LC-MS/MS for all convalescent plasma units that were transfused to patients. Severe COVID-19 patients with evidence for acute respiratory distress syndrome (ARDS) with PaO2/FiO2 ratio 100-300 (moderate ARDS) were recruited and randomised into two parallel arms of SOC and CPT, N=40 in each arm. Peripheral blood samples were collected on the day of enrolment (T1) followed by day3/4 (T2) and day 7 (T3). RT-PCR and sequencing was done for SARS-CoV2 RNA isolated from nasopharyngeal swabs collected at T1. A panel of cytokines and neutralizing antibody content were measured in plasma at all three timepoints. Patients were followed up for 30 days post-admission to assess the primary outcomes of all cause mortality and immunological correlates for clinical benefits.ResultsWhile across all age-groups no statistically significant clinical benefit was registered for patients in the CPT arm, significant immediate mitigation of hypoxia, reduction in hospital stay as well as survival benefit was recorded in severe COVID-19 patients with ARDS aged less than 67 years receiving convalescent plasma therapy. In addition to its neutralizing antibody content a prominent effect of convalescent plasma on attenuation of systemic cytokine levels possibly contributed to its benefits.ConclusionPrecise targeting of severe COVID-19 patients is necessary for reaping the clinical benefits of convalescent plasma therapy.Clinical trial registrationClinical Trial Registry of India No. CTRI/2020/05/025209

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Statin Treatment in the Acute Phase and the Risk of Post-stroke Pneumonia: A Retrospective Cohort Study

Frontiers in Neurology ◽

10.3389/fneur.2021.635079 ◽

2021 ◽

Vol 12 ◽

Author(s):

Changling Li ◽

Mengmeng Ma ◽

Shuju Dong ◽

Ye Hong ◽

Jiajia Bao ◽

...

Keyword(s):

Clinical Trial ◽

Acute Phase ◽

Statin Treatment ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Pneumonia Severity ◽

Post Stroke ◽

Significant Difference ◽

Before And After ◽

The Impact

Background: We aimed to investigate the impact of statin treatment in the acute phase on the risk and severity of post-stroke pneumonia because of the uncertain effects of statins on post-stroke pneumonia.Methods: Consecutive cases of acute ischemic stroke (AIS) between January 2014 and February 2019 were retrospectively analyzed. Additionally, the association of statin treatment in the acute phase with the risk and severity of post-stroke pneumonia was estimated with logistic regression. We registered the present study in the Chinese Clinical Trial Registry (ChiCTR 2000032838).Results: Of the 1,258 enrolled patients, no significant difference was observed in post-stroke pneumonia risk between the two groups (with/without statin treatment in the acute phase) after propensity score matching (35.1 vs. 27.9%, p = 0.155). We did not find statin treatment in the acute phase to significantly increase the risk of post-stroke pneumonia both before and after matched analysis [odds ratio (OR) = 1.51, 95% confidence interval (CI) = 0.85–2.67, p = 0.157; OR = 1.57, 95% CI = 0.77–3.18, p = 0.213, respectively]. In the 271 patients with post-stroke pneumonia, no significant difference was found in its severity between two groups (19.6 vs. 19.4%, p = 0.964). No significant association was found between statin treatment and post-stroke pneumonia severity (OR = 0.95, 95% CI = 0.39–2.31, p = 0.918).Conclusions: There appeared to be no additional benefits of statin treatment in the acute phase for post-stroke pneumonia reduction among AIS patients.Clinical Trial Registration:http://www.chictr.org.cn, identifier: ChiCTR2000032838.

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The effect of multimedia-based nursing visit on preoperative anxiety and vital signs in patients undergoing lumbar disc herniation surgery: A randomised clinical trial

Journal of Perioperative Practice ◽

10.1177/1750458917742045 ◽

2018 ◽

Vol 28 (1-2) ◽

pp. 7-15 ◽

Cited By ~ 5

Author(s):

Behrooz Zarei ◽

Sina Valiee ◽

Bijan Nouri ◽

Fatemeh Khosravi ◽

Mohammad Fathi

Keyword(s):

Clinical Trial ◽

Lumbar Disc Herniation ◽

Disc Herniation ◽

Lumbar Disc ◽

Vital Signs ◽

Randomised Clinical Trial ◽

Preoperative Anxiety ◽

Nursing Visit ◽

Significant Difference ◽

Before And After

This study was a randomised clinical trial on 60 candidates undergoing lumbar disc herniation surgery. Anxiety rate and vital signs were measured before and after the intervention. There was a statistically significant difference between the two groups in terms of the preoperative anxiety, systolic and diastolic blood pressure, pulse and respiratory rate (P = 0.0001). Neurosurgery perioperative nurses can make use of multimedia in preoperative nursing visit based on the needs of patients.

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The Potential Beneficial Effects Of Hand And Foot Bathing On Vital Signs In Women With Caesarean Section

Clinical & Investigative Medicine ◽

10.25011/cim.v39i6.27508 ◽

2016 ◽

Vol 39 (6) ◽

pp. 86 ◽

Cited By ~ 1

Author(s):

Elif Cal ◽

Busra Cakiroglu ◽

Ayse Nur Kurt ◽

Siti Sugih Hartiningsih ◽

Suryani ◽

...

Keyword(s):

Caesarean Section ◽

Pain Score ◽

Psychological Stress ◽

Simple Technique ◽

Vital Signs ◽

Control Group ◽

Study Group ◽

Beneficial Effects ◽

Before And After ◽

Blood Pressures

Purpose: Hand-foot bathing therapy is a simple technique to induce sensations of comfort and relaxation. The aim of this study was to examine the effect of hand and foot bathing therapy on vital signs in women following caesarean section. Methods: Participants were sixty women with caesarean section. They divided to two groups: (1) study group (n=30, median age=26.67 years, SD=2.04); and, (2) control group (n=30, median age=27.75 years, SD=1.09). Vital signs were measured for 5 minutes before and for 30 minutes after the hand and foot bathing therapy. Results: Pain score, systolic and diastolic blood pressures and heart and breath rates decreased after hand and foot bathing therapy. Differences between before and after therapy were statistically significantly. Conclusions: These results indicate that hand and foot bathing therapy might be helpful to restore the vital signs in post-operative patients by decreasing anxiety and psychological stress.

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Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

CNS & Neurological Disorders - Drug Targets ◽

10.2174/1871527320666211006141406 ◽

2021 ◽

Vol 20 ◽

Author(s):

Reza Aminnejad ◽

Ahmad Hormati ◽

Hamed Shafiee ◽

Faezeh Alemi ◽

Maryam Hormati ◽

...

Keyword(s):

Clinical Trial ◽

Pain Score ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Vital Signs ◽

P Value ◽

Chi Square ◽

Ramsay Sedation Scale ◽

Repeated Measures Analysis ◽

Double Blinded

Background: In this double-blinded randomized clinical trial, we aimed to compare the safety and efficacy of a combination of dexmedetomidine and ketamine [DK] with propofol and fentanyl [PF] for sedation in colonoscopy patients. Methods: In this study, 64 patients who underwent colonoscopy were randomized into two groups: 1) A, which received PF, and 2) B, which received DK for sedation. Among 64 patients, 31 patients were included in PF, and 33 patients were included in the DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsay sedation scale) and vital signs were recorded at 2, 5, 10, and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea, and vomiting, along with gastroenterologist satisfaction and patients’ pain score (based on Wong-Baker faces pain assessment scale), were recorded by a checklist. Data were analyzed by SPSS v.18 software, using chi-square, independent t-tests, and repeated measures analysis with p<0.05 as the criterion for significant differences. Results: The mean score of sedation was 4.82±0.49 in the DK group and 5.22±0.45 in the PF group [p value=0.001]. Serious complications, including hypotension [p value=0.005] and apnea [p value=0.10] were significantly higher in the PF group. Satisfaction of gastroenterologist [p value= 0.400] and patients’ pain score [p value = 0.900] were similar among groups. Conclusion: Combination of DK provides sufficient sedation with fewer complications in comparison with PF in colonoscopy patients.

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