Hydrolyzed Collagen Combined with Djulis and Green Caviar Improve Skin Condition: A Randomized, Placebo-Controlled Trial

Aging is a natural process that will cause physiological changes in organs. The effects of djulis and green caviar in skincare are currently unclear. This study combined hydrolyzed collagen with djulis and green caviar to develop new functional formulas that improve skin parameters. Fifty subjects were randomly assigned and divided into a placebo group (n=25) and a collagen drink group (n=25), and gave 50 ml of collagen of a collagen drink or placebo drink daily for 28 days, and we examined skin moisture, elasticity, gloss, spot, wrinkle, roughness, smoothness, pore, collagen and erythema. We find that intake of collagen drinks group improved skin parameters at 14 days and 28 days compared with baseline (0 day). The collagen drinks group improved skin parameters at 28 days compared with the placebo group. This clinical study proved the combination of collagen with djulis and green caviar for the substantial improvements in moisture, elasticity, gloss, spot, wrinkle, roughness, smoothness, pore, collagen, and erythema in the skin.

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Beneficial microbes for premature infants, and children with malignancy undergoing chemotherapy

Beneficial Microbes ◽

10.3920/bm2010.0035 ◽

2010 ◽

Vol 1 (4) ◽

pp. 357-365 ◽

Cited By ~ 11

Author(s):

Y. Yamashiro ◽

S. Nagata

Keyword(s):

Placebo Group ◽

Clinical Study ◽

Premature Infants ◽

Very Low Birth Weight ◽

Controlled Trial ◽

Infants And Children ◽

Mucosal Barrier ◽

Protective Effects ◽

Low Birth Weight Infants ◽

Study Results

This review reports the beneficial effects, observed in our clinical studies, of Bifidobacterium breve for premature infants, and children with cancers undergoing chemotherapy. To investigate the protective effects of B. breve (M-16V) as a probiotic on necrotizing enterocolitis (NEC) and infection in premature infants, we carried out a clinical study in 338 very low birth weight infants over a five-year period. These patients were supplemented with B. breve starting several hours after birth (Bifido group). 226 premature infants served as controls. Infants of the Bifido group were administered B. breve in a daily dose of 1×109 cells/day. The incidence of NEC was significantly reduced in the Bifido group (nil) compared with that in controls (6 cases, P<0.01). Infection also decreased significantly. Thus, administration of B. breve as a probiotic looks to be a very effective treatment for preventing NEC and infection in preterm infants. Mucositis, also referred to as mucosal barrier injury, is one of the most debilitating side effects of chemotherapy treatment. To evaluate the effects of the administration of B. breve (BBG-01, another strain than that used in the study of premature infants), a clinical study was performed to ascertain whether it attenuated intestinal mucositis in children with cancers on chemotherapy. A placebo-controlled trial was performed in patients with malignancies admitted for chemotherapy (n=42), who were randomised into two groups receiving probiotic or placebo. The frequency of fever and the use of intravenous antibiotics were significantly lower in the Bifido group than the placebo group. The B. breve administration enhanced the colonisation of anaerobes. Disruption of the intestinal microbiota after chemotherapy, such as the increase in the population levels of Enterobacteriaceae, was more pronounced in the placebo group. In conclusion, these data suggest that administration of B. breve is an effective approach to attenuating chemotherapy-induced mucositis in children with cancers. The study results strongly suggest that B. breve administration as a probiotic is an effective therapy for the prevention of NEC and infection in premature infants, and also a promising treatment for attenuating chemotherapy-induced mucositis in children with cancers.

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Therapeutic Effects of Hab Shabyar on Open-Angle Glaucoma: A Double-Blinded, Randomized, Placebo-Controlled Trial

10.31661/gmj.v0i0.1218 ◽

2019 ◽

Vol 8 ◽

pp. 1218

Author(s):

Ebrahim Khalil BaniHabib ◽

Ali Mostafai ◽

Seyyed Mohammad Bagher Fazljou ◽

Ghadir Mohammdi

Keyword(s):

Placebo Group ◽

Intraocular Pressure ◽

Open Angle Glaucoma ◽

Controlled Trial ◽

Intervention Group ◽

Therapeutic Effects ◽

Open Angle ◽

The Mean ◽

The Right ◽

Double Blinded

Background: Open-angle glaucoma (OAG) is one of the leading causes of blindness worldwide. This study evaluates the therapeutic effects of hab shabyar in patients with open-angle glaucoma. Materials and Methods: In this clinical randomized controlled trial, 50 patients with OAG were randomized into two groups. The intervention group was received a drop of timolol plus 500 mg of hab shabyar every 12 hours. The placebo group was received a drop of timolol every 12 hours plus 500 mg of wheat germ as a placebo. The intraocular pressure in patients with OAG was measured in each group and compared at before the intervention (t1), one month (t2), and two months (t3) after the intervention. Results: The mean decrease in intraocular pressure for the right eye at three times in the intervention group was statistically significant, but the mean decrease in the placebo group was not significant. Similar results were obtained for the left eye at t1 when compared to t3. The patients in the intervention group expressed more satisfaction than the patients in the placebo group (P≤0.001). Conclusion: Our study demonstrated that consumption of timolol plus hab shabyar instead of consuming of timolol alone was probably more effective for reducing intraocular pressure in patients with OAG.[GMJ.2019;In press:e1218]

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The Effect of Protein Supplementation versus Carbohydrate Supplementation on Muscle Damage Markers and Soreness Following a 15-km Road Race: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13030858 ◽

2021 ◽

Vol 13 (3) ◽

pp. 858

Author(s):

Dominique S. M. ten Haaf ◽

Martin A. Flipsen ◽

Astrid M. H. Horstman ◽

Hans Timmerman ◽

Monique A. H. Steegers ◽

...

Keyword(s):

Placebo Group ◽

Protein Intake ◽

Muscle Soreness ◽

Controlled Trial ◽

Protein Supplementation ◽

Group Differences ◽

Double Blind ◽

Carbohydrate Supplementation ◽

Protein Group ◽

Road Race

We assessed whether a protein supplementation protocol could attenuate running-induced muscle soreness and other muscle damage markers compared to iso-caloric placebo supplementation. A double-blind randomized controlled trial was performed among 323 recreational runners (age 44 ± 11 years, 56% men) participating in a 15-km road race. Participants received milk protein or carbohydrate supplementation, for three consecutive days post-race. Habitual protein intake was assessed using 24 h recalls. Race characteristics were determined and muscle soreness was assessed with the Brief Pain Inventory at baseline and 1–3 days post-race. In a subgroup (n = 149) muscle soreness was measured with a strain gauge algometer and creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations were measured. At baseline, no group-differences were observed for habitual protein intake (protein group: 79.9 ± 26.5 g/d versus placebo group: 82.0 ± 26.8 g/d, p = 0.49) and muscle soreness (protein: 0.45 ± 1.08 versus placebo: 0.44 ± 1.14, p = 0.96). Subjects completed the race with a running speed of 12 ± 2 km/h. With the Intention-to-Treat analysis no between-group differences were observed in reported muscle soreness. With the per-protocol analysis, however, the protein group reported higher muscle soreness 24 h post-race compared to the placebo group (2.96 ± 2.27 versus 2.46 ± 2.38, p = 0.039) and a lower pressure muscle pain threshold in the protein group compared to the placebo group (71.8 ± 30.0 N versus 83.9 ± 27.9 N, p = 0.019). No differences were found in concentrations of CK and LDH post-race between groups. Post-exercise protein supplementation is not more preferable than carbohydrate supplementation to reduce muscle soreness or other damage markers in recreational athletes with mostly a sufficient baseline protein intake running a 15-km road race.

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Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Cerebrovascular Diseases ◽

10.1159/000515233 ◽

2021 ◽

pp. 1-11

Author(s):

Nataliia U. Lashch ◽

Pavel R. Kamchatnov ◽

Tatiana N. Fedorova ◽

Olga A. Muzychuk ◽

Kristina K. Khacheva ◽

...

Keyword(s):

Cognitive Impairment ◽

Placebo Group ◽

Study Design ◽

Therapeutic Option ◽

Controlled Trial ◽

Prospective Trial ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Cerebral Atherosclerosis ◽

Endogenous Antioxidant

Objective: The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. Study Design: The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. Setting: The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation. Interventions: Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy. Outcomes: The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. Results: 124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (n = 65) or a placebo (n = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, p = 0.0272 [p = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (p = 0.007 [p = 0.0107]). Conclusions: Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

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Electrospun PCL Patches with Controlled Fiber Morphology and Mechanical Performance for Skin Moisturization via Long-Term Release of Hemp Oil for Atopic Dermatitis

Membranes ◽

10.3390/membranes11010026 ◽

2020 ◽

Vol 11 (1) ◽

pp. 26

Author(s):

Sara Metwally ◽

Daniel P. Ura ◽

Zuzanna J. Krysiak ◽

Łukasz Kaniuk ◽

Piotr K. Szewczyk ◽

...

Keyword(s):

Mechanical Properties ◽

Atopic Dermatitis ◽

Mechanical Performance ◽

Antibacterial Properties ◽

Skin Condition ◽

Fiber Morphology ◽

Suitable Material ◽

Hemp Oil ◽

Skin Moisture

Atopic dermatitis (AD) is a chronic, inflammatory skin condition, caused by wide genetic, environmental, or immunologic factors. AD is very common in children but can occur at any age. The lack of long-term treatments forces the development of new strategies for skin regeneration. Polycaprolactone (PCL) is a well-developed, tissue-compatible biomaterial showing also good mechanical properties. In our study, we designed the electrospun PCL patches with controlled architecture and topography for long-term release in time. Hemp oil shows anti-inflammatory and antibacterial properties, increasing also the skin moisture without clogging the pores. It can be used as an alternative cure for patients that do not respond to traditional treatments. In the study, we tested the mechanical properties of PCL fibers, and the hemp oil spreading together with the release in time measured on skin model and human skin. The PCL membranes are suitable material as patches or bandages, characterized by good mechanical properties and high permeability. Importantly, PCL patches showed release of hemp oil up to 55% within 6 h, increasing also the skin moisture up to 25%. Our results confirmed that electrospun PCL patches are great material as oil carriers indicating a high potential to be used as skin patches for AD skin treatment.

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Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽

10.3390/nu13072238 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2238

Author(s):

Xiaomei Zhang ◽

Shanbin Chen ◽

Ming Zhang ◽

Fazheng Ren ◽

Yimei Ren ◽

...

Keyword(s):

Mental Illness ◽

Placebo Group ◽

Rating Scale ◽

Controlled Trial ◽

Fermented Milk ◽

Daily Consumption ◽

Double Blind ◽

Tnf Α ◽

Significant Difference ◽

Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

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Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

Stroke and Vascular Neurology ◽

10.1136/svn-2021-000942 ◽

2021 ◽

pp. svn-2021-000942

Author(s):

Jingyi Liu ◽

Ximing Nie ◽

Hongqiu Gu ◽

Qi Zhou ◽

Haixin Sun ◽

...

Keyword(s):

Placebo Group ◽

Tranexamic Acid ◽

Intracerebral Haemorrhage ◽

Intracranial Haemorrhage ◽

Primary Outcome ◽

Controlled Trial ◽

Intracerebral Haematoma ◽

Spot Sign ◽

Double Blind ◽

Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

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Domperidone and maternal milk volume in mothers of premature newborns

Paediatrica Indonesiana ◽

10.14238/pi57.1.2017.18-22 ◽

2017 ◽

Vol 57 (1) ◽

pp. 18 ◽

Cited By ~ 2

Author(s):

Tengku Ellya Fazilla ◽

Guslihan Dasa Tjipta ◽

Muhammad Ali ◽

Pertin Sianturi

Keyword(s):

Placebo Group ◽

Breast Milk ◽

Milk Production ◽

Controlled Trial ◽

Maternal Milk ◽

Premature Newborns ◽

Breast Milk Production ◽

Days Of Therapy ◽

Significant Difference ◽

Milk Volume

Background Mothers of premature newborns often have difficulty giving adequate breast milk volume to their infants. Domperidone is an antagonist of peripheral dopamine receptors and believed to increase breast milk production. In Indonesia, no study has been done to date on the effect of domperidone on maternal milk production in mothers of premature newborns. Objective To evaluate the effect of domperidone on milk production in mothers of premature newborns who failed to lactate.Methods A randomized controlled trial was conducted from July to December 2012 in the Perinatology Unit, Haji Adam Malik Hospital, Medan. Mothers of premature newborns were given lactation counseling for 7 days in order to increase their milk production. Mothers who failed to lactate after that time were enrolled in the study. Fifty subjects were assigned to receive either domperidone or a placebo for 7 days. Milk volume was measured every 2 hours (from 7 am to 9 pm), in the 24 hours before starting therapy, and on the 7th and 10th days (the 10th day being 3 days after stopping therapy). Results This study involved 25 mothers in the domperidone groups and 25 others in placebo group. After 7 days of therapy, mean breast milk volume was significantly higher in the domperidone group than in the placebo group [181.6 (SD 80.2) vs. 72.4 (SD 57.8) mL, respectively; 95%CI of differences 69.36 to 148.93; P=0.0001]. At day 10, breast milk production remained significantly higher in the domperidone group. Furthermore, in the domperidone group, no significant difference in mean breast milk volumes was noted between the 7th and 10th days (P=0.65). Conclusion In mothers of premature newborns who failed to lactate, domperidone therapy for 7 days causes significantly higher milk production compared to placebo.

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A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

Psychological Medicine ◽

10.1017/s0033291711000201 ◽

2011 ◽

Vol 41 (10) ◽

pp. 2159-2166 ◽

Cited By ~ 20

Author(s):

Y. Panahi ◽

B. Rezazadeh Moghaddam ◽

A. Sahebkar ◽

M. Abbasi Nazari ◽

F. Beiraghdar ◽

...

Keyword(s):

Placebo Group ◽

Post Traumatic Stress Disorder ◽

Traumatic Stress ◽

Stress Disorder ◽

Controlled Trial ◽

Post Traumatic Stress ◽

Double Blind ◽

Double Blind Placebo ◽

Post Traumatic ◽

The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

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Effect of specialized bathing systems on resident cleanliness and water quality in nursing homes: a randomized controlled trial

Journal of Water and Health ◽

10.2166/wh.2007.007b ◽

2007 ◽

Vol 5 (2) ◽

pp. 283-294 ◽

Cited By ~ 3

Author(s):

Philip D. Sloane ◽

Lauren W. Cohen ◽

Christianna S. Williams ◽

Jean Munn ◽

John S. Preisser ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Bacterial Colonization ◽

Controlled Trial ◽

Nursing Home Residents ◽

Skin Condition ◽

Microbial Flora ◽

Control Treatment ◽

Staff Satisfaction ◽

Randomized Controlled ◽

The Impact

A randomized controlled trial evaluated the impact of different methods of water agitation on clinical and microbiological outcomes in 31 nursing home residents. Four conditions were tested: a) whirlpool tub, jets on, using standard soap products; b) ultrasound tub, ultrasound on, using the standard soap products; c) ultrasound tub, ultrasound on, using specialized soap and skin conditioner; and d) either tub (randomized), water circulation off, using standard soap products (the control condition). Outcomes of interest included skin microbial flora, water microbial flora, skin condition, time spent bathing, and staff satisfaction. Resident skin condition and skin microbial flora did not differ between the four treatments. The tubs also did not differ in terms of bacterial colonization; however, there was a non-statistically significant trend for the highest counts to occur in whirlpool tubs after being idle overnight. The ultrasound and whirlpool tubs were preferred by staff over the control treatment (still water) in terms of sound and overall suitability. In addition, staff reported that the ultrasound tub using enhanced skin cleansers made bathing residents easier and faster than the same tub using standard cleansers.

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