scholarly journals Effects of Collagen Hydrolysates on Human Brain Structure and Cognitive Function: A Pilot Clinical Study

Nutrients ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 50
Author(s):  
Seiko Koizumi ◽  
Naoki Inoue ◽  
Fumihito Sugihara ◽  
Michiya Igase
Keyword(s):  
Cognitive Function ◽  
Outcome Measures ◽  
Brain Structure ◽  
Short Form ◽  
Gray Matter Volume ◽  
Rank Correlation ◽  
Secondary Outcome ◽  
Open Label ◽  
Associate Learning ◽  
Collagen Hydrolysates

This study investigated the effects of collagen hydrolysates (CH) on language cognitive function and brain structure. In this open-label study, 5 g CH was administered once a day for 4 weeks to 30 healthy participants aged 49–63 years. The primary outcome measures were the brain healthcare quotients based on gray matter volume (GM-BHQ) and fractional anisotropy (FA-BHQ). The secondary outcome measures were changes in scores between week 0 and week 4 for word list memory (WLM) and standard verbal paired associate learning (S-PA) tests as well as changes in the physical, mental, and role/social component summary scores of the Short Form-36(SF-36) quality of life instrument. CH ingestion resulted in significant improvements in FA-BHQ (p = 0.0095), a measure of brain structure, as well in scores for the WLM (p = 0.0046) and S-PA (p = 0.0007) tests, which measure cognitive function. There were moderate correlations between the change in WLM score and the change in GM-BHQ (r = 0.4448; Spearman’s rank correlation) and between the change in S-PA score and the change in FA-BHQ (r = 0.4645). Daily ingestion of CH changed brain structure and improved language cognitive function.

scholarly journals Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036061
Author(s):  
Jing Ma ◽  
Jian wei Zhang ◽  
Hua Li ◽  
Lian shan Zhao ◽  
Ai ying Guo ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Outcome Measures ◽  
Tai Chi ◽  
Short Form ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Cardiac Rehabilitation Programme ◽  
Tai Chi Exercise ◽  
Randomised Controlled

IntroductionPreliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.Methods and analysisWe propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.Ethics and disseminationThis study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People’s Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.Trial registration numberNCT03936504.

Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: a randomized controlled trial

2020 ◽  
Vol 34 (8) ◽  
pp. 1028-1039 ◽  
Author(s):  
Guohua Zheng ◽  
Yuhui Zheng ◽  
Zhenyu Xiong ◽  
Bingzhao Ye
Keyword(s):  
Cognitive Impairment ◽  
Cognitive Function ◽  
Outcome Measures ◽  
Daily Living ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Rehabilitation Treatment ◽  
Global Cognitive Function ◽  
Delayed Recognition

Objective: To investigate the effectiveness and safety of Baduanjin training on the cognitive function in stroke survivors with cognitive impairment. Design: A randomized, two-arm parallel controlled trial with allocation concealment and assessors blinding. Setting: Community centre of Fuzhou city, China. Subjects: A total of 48 participants were recruited and randomly allocated into the Baduanjin exercise intervention or control group. Interventions: The control group maintained original medication and rehabilitation treatment. The Baduanjin training group received 24-week Baduanjin training with a frequency of three days a week and 40 minutes a day based on original medication and rehabilitation treatment. Main outcome measures: The primary outcome was global cognitive function. Secondary outcome measures included the specific domains of cognition (i.e. memory, processing speed, execution, attention and visuospatial ability) and activities daily living. Results: In total, 41 (Baduanjin n = 22, control n = 19) participants completed 24-week treatment and data collection. Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: −42.4 (−75.0 to −9.8); TMT-B: −71.3 (−130.6 to −12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: −245.5 (−387 to −104)) and activities of daily living (modified Barthel Index). Conclusion: Regular Baduanjin training is associated with less loss of cognitive function in patients after stroke.

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 Montelukast as an Alternative to Low-Dose Inhaled Corticosteroids in the Management of Mild Asthma (The SIMPLE Trial): An Open-Label Effectiveness Trial

2009 ◽  
Vol 16 (suppl a) ◽  
pp. 11A-16A ◽  
Author(s):  
R Andrew McIvor ◽  
Alan Kaplan ◽  
Caroline Koch ◽  
John S Sampalis
Keyword(s):  
Asthma Control ◽  
Outcome Measures ◽  
Low Dose ◽  
Inhaled Corticosteroids ◽  
Symptom Control ◽  
Physician Satisfaction ◽  
Mild Asthma ◽  
Secondary Outcome ◽  
Open Label ◽  
Number Of Patients

OBJECTIVE: To evaluate the effectiveness of montelukast as monotherapy for patients with mild asthma who remain uncontrolled or unsatisfied while on inhaled corticosteroid (ICS) monotherapy.DESIGN: A multicentre, open-label study. Patients (six years of age or older) had ICS therapy discontinued and were treated with orally administered montelukast once daily for six weeks.MAIN OUTCOME MEASURES: The primary outcome measure was the rate at which asthma symptom control was achieved or maintained after six weeks of treatment. The secondary outcome measures were to compare compliance and physician satisfaction, and to further assess the safety and tolerability of montelukast.RESULTS: Of the 534 patients enrolled, 481 (90.1%) completed the study. Mean (± SD) age was 27.8±19.0 years. The number of patients with uncontrolled symptoms decreased from 455 (85.2%) at baseline to 143 (26.8%) at week 6 (P<0.001), and mean Asthma Control Questionnaire score decreased from 1.4±0.8 to 0.6±0.6 (P<0.001), representing a clinically significant improvement. Of the 79 patients with controlled asthma symptoms at baseline, 73.4% maintained asthma control at week 6. Compliance to asthma therapy increased from 41% at baseline for ICS to 88% at week 6 for montelukast (P<0.001). Physician satisfaction with treatment increased from 43% to 85% (P<0.001) and patient satisfaction increased from 45% at baseline to 94% at week 6. No serious adverse events were reported over the course of the study.CONCLUSION: Montelukast is an effective and well-tolerated alternative to ICS treatment in patients with mild asthma who are uncontrolled or unsatisfied with low-dose ICS therapy.

scholarly journals Evaluation of Epidural Analgesic Paste Components in Lumbar Decompressive Surgery

Neurosurgery ◽  
2011 ◽  
Vol 70 (2) ◽  
pp. 414-424 ◽  
Author(s):  
Roberto Jose Diaz ◽  
S. Terry Myles ◽  
R. John Hurlbert
Keyword(s):  
Postoperative Pain ◽  
Outcome Measures ◽  
Short Form ◽  
Decompressive Surgery ◽  
Secondary Outcome ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Consumption ◽  
Sf 36 ◽  
Cord Injury ◽  
Discharge From Hospital

Abstract BACKGROUND: Adjuncts for pain management in lumbar decompressive surgery are needed to reduce narcotic consumption and promote early mobility. OBJECTIVE: To evaluate the efficacy and active components of a previously described epidural analgesic paste in controlling postoperative pain and facilitating early discharge from hospital after lumbar decompressive surgery. METHODS: A randomized double-blind controlled trial was conducted. Two-hundred and one patients were randomized to 1 of 4 analgesic epidural pastes at the time of lumbar spinal surgery: combination paste (morphine + methylprednisolone), steroid paste (methylprednisolone alone), morphine paste (morphine alone), or placebo. The primary outcome measures used were analgesic consumption and the McGill Pain Questionnaire (MPQ). Secondary outcome measures were: modified American Spinal Cord Injury Association (ASIA) score, Short Form 36 General Health Survey (SF-36), Aberdeen Pain Index (ABPI), time to ambulation and time to discharge from hospital. RESULTS: Administration of combination and steroid paste, but not morphine paste, resulted in a statistically significant reduction in mean pain rating index (PRI) and present pain intensity (PPI) components of the MPQ in the first 3 days after surgery. Likewise, postoperative in-patient narcotic analgesic consumption was reduced in the combination paste and steroid paste group, but not in the morphine paste group. No difference in time to ambulation or discharge, SF-36 scores, ABPI scores, or neurologic recovery was observed. CONCLUSION: An analgesic paste containing methylprednisolone acetate is effective at reducing postoperative pain after lumbar decompressive surgery. Mixing effective doses of morphine sulfate in the paste abrogates the expected analgesic effects of epidural morphine.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals An open label single arm prospective clinical study on Vatagajankusha Rasa with Pippali Churna and Manjishta Kwatha as Anupana in Pakshaghata (CVA due to Infarct)

2019 ◽  
Vol 4 (06) ◽  
Author(s):  
Yadu Gopan ◽  
Totad Muttappa ◽  
Vasantha B. ◽  
Kiran K.
Keyword(s):  
Clinical Study ◽  
Outcome Measures ◽  
Ordinal Data ◽  
Secondary Outcome ◽  
Prospective Clinical Study ◽  
Rank Tests ◽  
Open Label ◽  
Signed Rank ◽  
Non Parametric

Background: Pakshaghata is one among the 80 vataja nanatmaja vikara and is a roga of madhyama roga marga. Vatavyadhi is considered to be one among the ashta mahagadas. Vatagajankusha rasa is a combination of vyosha, bhasmas, vatsanabha, karkatasringi, haritaki etc. It has vatakaphahara, vikasi, vyavayi, rasayana etc properties. It is said to be effective in treating pakshaghata in 7 days if given along with Pippali churna and Manjishta kwatha. Aims and Objectives: To evaluate the efficacy of Vatagajankusha rasa with Pippali churna and Manjishta kwatha as anupana in the management of pakshaghata (CVA due to infarct). Methodology: Among 32 registered patients, 30 completed the course of treatment. They were administered with Vatagajankusha rasa 1 tablet (125 mg) after food with anupana 3gm Pippali churna and 15 ml Manjishta kwatha twice daily (morning and evening) for a period of 7 days. Nominal and ordinal data were analysed using non parametric tests like McNemar and Wilcoxon’s signed rank tests respectively. Result: There was statistically significant improvement in the primary and secondary outcome measures (p less than 0.05 was observed). Conclusion: Vatagajankusha rasa with Pippali churna and Manjishta kwatha as anupana is effective in the management of Pakshaghata (CVA due to infarct).

scholarly journals A randomized controlled trial of intranasal oxytocin in Phelan-McDermid syndrome

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
J. Fastman ◽  
J. Foss-Feig ◽  
Y. Frank ◽  
D. Halpern ◽  
H. Harony-Nicolas ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Neurodevelopmental Disorder ◽  
Autism Spectrum ◽  
Small Sample ◽  
Social Recognition ◽  
Secondary Outcome ◽  
Open Label ◽  
Double Blind ◽  
The Core ◽  
Core Symptoms

Abstract Background Phelan-McDermid syndrome (PMS) is a rare neurodevelopmental disorder caused by haploinsufficiency of the SHANK3 gene and characterized by global developmental delays, deficits in speech and motor function, and autism spectrum disorder (ASD). Monogenic causes of ASD such as PMS are well suited to investigations with novel therapeutics, as interventions can be targeted based on established genetic etiology. While preclinical studies have demonstrated that the neuropeptide oxytocin can reverse electrophysiological, attentional, and social recognition memory deficits in Shank3-deficient rats, there have been no trials in individuals with PMS. The purpose of this study is to assess the efficacy and safety of intranasal oxytocin as a treatment for the core symptoms of ASD in a cohort of children with PMS. Methods Eighteen children aged 5–17 with PMS were enrolled. Participants were randomized to receive intranasal oxytocin or placebo (intranasal saline) and underwent treatment during a 12-week double-blind, parallel group phase, followed by a 12-week open-label extension phase during which all participants received oxytocin. Efficacy was assessed using the primary outcome of the Aberrant Behavior Checklist-Social Withdrawal (ABC-SW) subscale as well as a number of secondary outcome measures related to the core symptoms of ASD. Safety was monitored throughout the study period. Results There was no statistically significant improvement with oxytocin as compared to placebo on the ABC-SW (Mann–Whitney U = 50, p = 0.055), or on any secondary outcome measures, during either the double-blind or open-label phases. Oxytocin was generally well tolerated, and there were no serious adverse events. Limitations The small sample size, potential challenges with drug administration, and expectancy bias due to relying on parent reported outcome measures may all contribute to limitations in interpreting results. Conclusion Our results suggest that intranasal oxytocin is not efficacious in improving the core symptoms of ASD in children with PMS. Trial registration NCT02710084.

scholarly journals Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial

2014 ◽  
Vol 26 (5) ◽  
pp. 280-290 ◽  
Author(s):  
Triptish Bhatia ◽  
Sati Mazumdar ◽  
Nagendra Narayan Mishra ◽  
Raquel E. Gur ◽  
Ruben C. Gur ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Clinical Severity ◽  
Secondary Outcome ◽  
Daily Functioning ◽  
Beneficial Effects ◽  
Living Skills ◽  
Randomised Controlled

BackgroundSchizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ.AimsTo describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated.MethodsConsenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures.ResultsA total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported.ConclusionsShort term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients.

Efficacy of a standardised saffron extract (affron®) as an add-on to antidepressant medication for the treatment of persistent depressive symptoms in adults: A randomised, double-blind, placebo-controlled study

2019 ◽  
Vol 33 (11) ◽  
pp. 1415-1427 ◽  
Author(s):  
Adrian L Lopresti ◽  
Stephen J Smith ◽  
Sean D Hood ◽  
Peter D Drummond
Keyword(s):  
Depressive Symptoms ◽  
Outcome Measures ◽  
Short Form ◽  
Self Report ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Persistent Depression ◽  
Saffron Extract

Background: As a stand-alone intervention, saffron has efficacy for the treatment of mild-to-moderate depression. However, research as an adjunct agent is limited. Aims: The effects of saffron as an adjunct to pharmaceutical antidepressants in adults with persistent depression was investigated. Methods: In this eight-week, randomised, double-blind, placebo-controlled study, adults with persistent depression, currently taking a pharmaceutical antidepressant were given a placebo or a saffron extract (affron®, 14 mg b.i.d.). Primary outcome measures included the clinician-rated Montgomery–Åsberg Depression Rating Scale (MADRS) and self-rated MADRS (MADRS-S). Secondary outcome measures included the Antidepressant Side-Effect Checklist (ASEC) and Short Form-36 Health Survey (SF-36). Results: Of the 160 participants enrolled, 139 provided usable data. Based on the MADRS, depressive symptoms decreased more in participants taking saffron compared with a placebo, with reductions of 41 and 21%, respectively ( p = 0.001). However, scores on the MADRS-S decreased 27 and 26% in the saffron and placebo conditions, respectively ( p = 0.831). Saffron was associated with a greater reduction in adverse effects of antidepressants ( p = 0.019), although this was non-significant after covarying for baseline values ( p = 0.449). Quality of life improved in both groups with no significant between-group differences ( p = 0.638). Conclusion: Adjunctive administration of a standardised saffron extract (affron®) for eight weeks was associated with a greater improvement in depressive symptoms as measured by the clinician-rated MADRS but not the self-report MADRS-S. Given the conflicting results, further research is needed to clarify the clinical benefits of saffron as an adjunctive treatment for adults with persistent depressive symptoms despite antidepressant drug treatment.

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