scholarly journals Nicotinamide Riboside as a Neuroprotective Therapy for Glaucoma Study Protocol for a Randomized, Double-blind, Placebo-control Trial

2021 ◽  
Author(s):  
Christopher Kai-shun Leung ◽  
Seraph Tianmin Ren ◽  
Poemen Pui-man Chan ◽  
Kelvin H Wan ◽  
Aziz Kam ◽  
...  
Keyword(s):  
Optic Nerve ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Nerve Degeneration ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Nicotinamide Riboside ◽  
Optic Nerve Degeneration

Abstract Background Whereas lowering the intraocular pressure (IOP) can slow optic nerve degeneration in glaucoma, many patients with glaucoma continue to develop progressive loss in vision despite significant reduction in IOP. No treatment has been shown to be effective for neuroprotection in glaucoma. We set out to conduct a randomized controlled trial to investigate whether nicotinamide riboside (NR), a nicotinamide adenine dinucleotide precursor, is effective to slow optic nerve degeneration in patients with primary open-angle glaucoma (POAG). We hypothesize that patients treated with NR have a slower rate of progressive retinal nerve fiber layer (RNFL) thinning compared with those treated with placebo. Methods This is a randomized, double blind, placebo controlled, parallel group, multi-center study including 125 patients with POAG. Patients will be randomized to receive 300mg NR or placebo for 24 months. Clinical examination, optical coherence tomography imaging of the RNFL, and visual field (VF) test will be performed at the baseline, 1 month, 4 months, and then at 2-month intervals until 24 months. The primary outcome measure is the rate of RNFL thinning measured over 24 months. The secondary outcome measures include (1) time to VF progression, (2) time to progressive RNFL/ganglion cell inner plexiform layer (GCIPL) thinning, and (3) the rate of change of VF sensitivity over 24 months (to investigate neuroprotection) and 1 month (to investigate neuroenhancement). The rates of RNFL thinning and VF sensitivity decline between treatment groups will be compared with linear mixed modeling. Survival analysis will be performed to compare the differences in time from baseline to VF progression and time from baseline to progressive RNFL/GCIPL thinning between treatment groups using Cox proportional hazards models. Discussion Outcome measures in glaucoma neuroprotection trials have been predicated on detection of VF progression, which may take years to develop and confirm. In addition to addressing whether NR has a neuroprotective/neuroenhancement effect in glaucoma patients, this study will demonstrate the feasibility of studying neuroprotection in a relatively short trial period (24 months) by comparing the rates of progressive RNFL thinning, a more reproducible and objective outcome measure compared with VF endpoints, between treatment groups.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Herbs of rich-Iodine for Graves’ Hyperthyroidism Trial (the HIGHT trial): a study protocol for a randomized, double-blind, placebo-controlled, multicentre clinical trial

2021 ◽  
Author(s):  
Chenghan Gao ◽  
Xiaowei Liu ◽  
Xuefeng Guan ◽  
Qingyang Liu ◽  
Yiwen Lai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Outcome Measures ◽  
Thyroid Stimulating Hormone ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicentre Clinical Trial ◽  
Chinese Herbal ◽  
Stimulating Hormone

Abstract BackgroundGraves' hyperthyroidism is one of the refractory diseases in endocrinology. Thionamides are known to be effective and its common side-effects are markedly reduced when starting with low dose. Iodine-rich Chinese herbal decoction (IRH) is a frequently prescribed Chinese herbal medicine in patients with Graves' hyperthyroidism. However, high quality clinical evidence is still very scarce, which made the Traditional Chinese Medical (TCM) management of Graves' hyperthyroidism remains controversial. The objective of this study is to prove that IRH might get faster and longer lasting remission and improved quality of life (QoL) in Graves' hyperthyroidism patients compared with methimazole (MMI) .Methods/designThis study is a randomized, double-blind, placebo-controlled and multicentre clinical trial. We will recruit a total of 240 participants with Graves' hyperthyroidism who have any common ATD-associated side-effects. They will be randomized (1:1:1) to receive (ⅰ) IRH plus MMI placebo, (ⅱ) IRH placebo plus MMI and (ⅲ) IRH plus MMI for 12 weeks. The primary outcome measures will be the serum free triiodothyronine (FT3), free thyroxine (FT4) levels and serum thyroid-stimulating hormone (TSH) level. Secondary outcome measures will include the level of thyroid stimulating hormone-receptor antibodies (TRAb), thyroid ultrasound (US) and Thyroid-specific Patient Reported Outcome(ThyPRO39).DiscussionThe outcomes of this study will provide new evidence for the efficacy and safety of IRH for the treatment of Graves' hyperthyroidism and will also guide physicians at clinics more clearly in prescribing IRH.Trial registration number:ChiCTR, ChiCTR2000032706. Registered 7 May 2020, http://www.chictr.org.cn

scholarly journals Axonal Protection by Nicotinamide Riboside via SIRT1-Autophagy Pathway in TNF-Induced Optic Nerve Degeneration

2020 ◽  
Vol 57 (12) ◽  
pp. 4952-4960
Author(s):  
Yasushi Kitaoka ◽  
Kana Sase ◽  
Chihiro Tsukahara ◽  
Naoki Fujita ◽  
Ibuki Arizono ◽  
...  
Keyword(s):  
Optic Nerve ◽  
Ganglion Cells ◽  
Immunohistochemical Analysis ◽  
Nerve Fibers ◽  
Nerve Degeneration ◽  
Autophagic Flux ◽  
Nicotinamide Riboside ◽  
Axon Loss ◽  
Autophagy Pathway ◽  
Optic Nerve Degeneration

Abstract Nicotinamide adenine dinucleotide (NAD+) synthesis pathway has been involved in many biological functions. Nicotinamide riboside (NR) is widely used as an NAD+ precursor and known to increase NAD+ level in several tissues. The present study aimed to examine the effect of NR on tumor necrosis factor (TNF)-induced optic nerve degeneration and to investigate whether it alters SIRT1 expression and autophagic status in optic nerve. We also examined the localization of nicotinamide riboside kinase 1 (NRK1), which is a downstream enzyme for NR biosynthesis pathway in retina and optic nerve. Intravitreal injection of TNF or TNF plus NR was performed on rats. The p62 and LC3-II protein levels were examined to evaluate autophagic flux in optic nerve. Immunohistochemical analysis was performed to localize NRK1 expression. Morphometric analysis showed substantial axonal protection by NR against TNF-induced axon loss. TNF-induced increment of p62 protein level was significantly inhibited by NR administration. NR administration alone significantly increased the LC3-II levels and reduced p62 levels compared with the basal levels, and upregulated SIRT1 levels in optic nerve. Immunohistochemical analysis showed that NRK1 exists in retinal ganglion cells (RGCs) and nerve fibers in retina and optic nerve. NR administration apparently upregulated NRK1 levels in the TNF-treated eyes as well as the control eyes. Pre-injection of an SIRT1 inhibitor resulted in a significant increase of p62 levels in the NR plus TNF treatment group, implicating that SIRT1 regulates autophagy status. In conclusion, NRK1 exists in RGCs and optic nerve axons. NR exerted protection against axon loss induced by TNF with possible involvement of upregulated NRK1 and SIRT1-autophagy pathway.

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.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Random Allocation ◽  
1H Mrs ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-eight participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention after random allocation. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-eight participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification

Intervention Outcomes of Two Treatments for Muscle Tension Dysphonia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (2) ◽  
pp. 272-282 ◽  
Author(s):  
Christopher R. Watts ◽  
Amy Hamilton ◽  
Laura Toles ◽  
Lesley Childs ◽  
Ted Mau
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Muscle Tension ◽  
Primary Outcome Measure ◽  
Voice Therapy ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Perceptual Evaluation ◽  
Muscle Tension Dysphonia

Purpose The aim of this study was to test the hypothesis that stretch-and-flow voice therapy (SnF) is noninferior to resonant voice therapy (RVT) for speakers with muscle tension dysphonia. Method Participants with primary muscle tension dysphonia were randomly assigned to 1 of 2 treatment groups. Participants received 6 sessions of either SnF or RVT for 6 weeks (1 session per week). Pretreatment and posttreatment audio recordings of sustained vowels and connected speech were acquired. Response to treatment was assessed using the voice handicap index (VHI) as the primary outcome measure. Secondary outcome measures included the acoustic voice quality index, the smoothed cepstral peak prominence, and scales from the Consensus Auditory-Perceptual Evaluation of Voice instrument. Data were analyzed for 21 participants who completed the study (12 in the SnF group, 9 in the RVT group). Results Direction of change for the primary outcome measure and all 3 secondary outcome measures at posttreatment was in the direction of improvement for both SnF and RVT. Confidence intervals for VHI measures did not cross the null effect line on forest plots, suggesting significant effects for both treatments on the primary outcome measure. The effect sizes for pretreatment to posttreatment changes in VHI were large for both treatment groups. Similar results were found for the secondary acoustic outcome measures. There were statistically significant pretreatment to posttreatment changes in the primary and secondary outcome measures for patients receiving both treatments, indicating significant improvement in response to both RVT and SnF. There were no statistically significant differences in pretreatment to posttreatment changes in the primary outcome measure or any secondary outcome measure between the two groups. The within-group pretreatment to posttreatment changes in Consensus Auditory-Perceptual Evaluation of Voice scales did not reach statistical significance for either RVT or SnF. Conclusions Both SnF and RVT produced positive treatment response in speakers with muscle tension dysphonia, with no statistically significant difference in the outcome measures between the two treatments. This suggests that SnF is noninferior to RVT and that both are effective options for treating vocal hyperfunction. Results from this study also support previous findings documenting the sensitivity of multidimensional acoustic measurements to treatment response.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Link Type ◽  
Insomnia Symptoms

Abstract Background Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW. Trial registration Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.

scholarly journals Effects of Lactobacillus plantarum PS128 on Children with Autism Spectrum Disorder in Taiwan: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 820 ◽  
Author(s):  
Liu ◽  
Liong ◽  
Chung ◽  
Huang ◽  
Peng ◽  
...  
Keyword(s):  
Autism Spectrum Disorder ◽  
Lactobacillus Plantarum ◽  
Outcome Measure ◽  
Autism Spectrum ◽  
Spectrum Disorder ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo

This four-week, randomized, double-blind, placebo-controlled study investigated the effects of Lactobacillus plantarum PS128 (PS128) on boys with autism spectrum disorder (ASD) aged 7–15 in Taiwan. All subjects fulfilled the criteria for ASD diagnosis of DSM-V and the Autism Diagnostic Interview-Revised (ADI-R). Questionnaires used for the primary outcome measure include the Autism Behavior Checklist-Taiwan version (ABC-T), the Social Responsiveness Scale (SRS) and the Child Behavior Checklist (CBCL). The Swanson, Nolan, and Pelham-IV-Taiwan version (SNAP-IV) and the Clinical Global Impression-improvement (CGI-I) were used for the secondary outcome measure. The results showed that PS128 ameliorated opposition/defiance behaviors, and that the total score of SNAP-IV for younger children (aged 712) improved significantly compared with the placebo group. Additionally, several elements were also notably improved in the PS128 group after 28-day consumption of PS128. Further studies are needed to better clarify the effects of PS128 for younger children with ASD on broader symptoms.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty- four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1 H-magnetic resonance spectroscopy ( 1 H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin . A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration : Chinese Clinical Trial Registry, ChiCTR1 800019239.Registered on 1 st November 2018- Retrospectively registered, http://www.chictr.org.cn/.

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