Clinical Trials on
Gamma Oryzanol & formulations with Gamma Oryzanol as the active ingredient on stress/ anxiety/ insomnia/ sleep issues
Title Of The Study: Rice bran extract supplement improves sleep efficiency and sleep onset in adults with sleep disturbance: A randomized, double-blind, placebo-controlled, polysomnographic study
We previously reported that rice bran extract supplement (RBS) administration to mice decreased sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition of the histamine H1 receptor. Based on this, we performed the first clinical trial to investigate whether RBS would be beneficial to subjects with disturbed sleep. We performed a randomized, double-blinded, placebo-controlled, 2-week study. Fifty subjects with sleep disturbance were enrolled and received either RBS (1,000 mg/day) or placebo. Polysomnography was performed, and Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale were administered at the initiation and termination of the study. Compared with the placebo, RBS led to significant polysomnographic changes, including decreased sleep latency (adjusted, P = 0.047), increased total sleep time (P = 0.019), and improved sleep efficiency (P = 0.010). Additionally, the amount of stage 2 sleep significantly increased in the RBS group. When adjusted for caffeine intake, wakefulness after sleep onset, total wake time, and delta activity tended to decrease in the RBS group. RBS administration decreased ESS scores. There were no reported serious adverse events in both groups. RBS improved sleep in adults with sleep disturbance. Trial registration: WHO ICTRP, KCT0001893.
Title Of The Study: g-Oryzanol produces an antidepressant-like effect in a chronic unpredictable mild stress model of depression in Drosophila melanogaster
Chronic unpredictable mild stress (CUMS) is a valid model for inducing depression-like symptoms in animal models, causing predictive behavioral, neurochemical, and physiological responses to this condi- tion. This work aims to evaluate the possible antidepressant effect of c-oryzanol (ORY) in the CUMS- induced depressive model in male Drosophila melanogaster. We will use the CUMS protocol to continue the study previously conducted by our research group, mimicking a depressive state in these insects. Male flies were subjected to various stressors according to a 10-day randomized schedule and con- comitantly treated with ORY or fluoxetine (FLX). After the experimental period, in vivo behavioral tests were performed (open field, forced swimming, aggressiveness test, mating test, male virility, sucrose preference index and light/dark test) and ex vivo analyses measuring serotonin (5HT), dopamine (DA), octopamine (OCT) levels and body weight. We report here that ORY-treated flies and concomitant exposure to CUMS did not exhibit obvious behaviors such as prolonged immobility or increased aggressive behavior, reduced male mating and virility behavior, and anxiolytic behavior, in contrast to ORY, not altering sucrose preference and body weight flies exposed to CUMS. ORY effectively pre- vented 5HT and OCT reduction and partially protected against DA reduction. The data presented here are consistent and provide evidence for the use of ORY as a potential antidepressant compound.
Title Of The Study: Control Study of Quetiapine Combined with Oryzanol Vitamin B1 And Vitamin B6 Tablets in Senile Schizophrenia
Objective To investigate the efficacy and safety of quetiapine combined with oryzanol and double vitamin B in the treatment of elderly schizophrenia. Methods Seventy-four elderly patients with schizophrenia who were admitted to the Second Affiliated Hospital of Xinxiang Medical College from October 2012 to October 2013 were randomly divided into two groups. Control group and observation group, 37 cases in each group. The control group was treated with oral quetiapine, and the observation group was treated with quetiapine + oryzanol double-dimensional B treatment. (CGI) and Adverse Reaction Scale (TESS) to evaluate the efficacy and adverse reactions. Results The marked and effective rates of the control group were 64.86% and 86.47%, respectively, and the observation group was 75.68% and 94.59%, respectively. There were significant differences in the efficiency and effective rate (P＜0.05). From the 4th week of treatment, the PANSS total score and CGI total score of the observation group were significantly lower than those of the control group, and the differences were statistically significant (P＜0.05 or P＜0.01). The TESS score in the first 4 weeks of the observation group was significantly lower than that of the control group (P＜0.05 or P＜0.01). Conclusion Quetiapine combined with oryzanol and double-dimensional B is effective in treating senile schizophrenia , good security.
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Title Of The Study: Deanxit Combined with Large Dose of Oryzanol in Treatment of Post Stroke Depression and Anxiety in
Elderly Male
Objective To investigate the therapy effect of deanxit combined with large dose of oryzanol in the treatment of post stroke depression(PSD) and anxiety in elderly male.Methods Sixty cases of PSD and anxiety patients were divided into three groups by random number table method with 20 cases in each,deanxit group treated with deanxit,oryzanol group treated with oryzanol,and combination group treated with deanxit and large dose of oryzanol,a total of 4 weeks.Before and after 4 weeks treatment respectively using Hamilton depression scale (HAMD) and Hamilton anxiety scale (HAMA) scores.Results The HAMD and HAMA scores before treatment in three groups had no statistical significance (P ＞ 0.05).Compared with before treatment,HAMD and HAMA scores in three groups after treatment were significantly lower (P＜ 0.01).HAMD scores in combination group were improved better than those in deanxit group and oryzanol group [(12.85 ± 3.69) scores vs.(15.30 ± 3.28),(18.65 ± 3.13) scores](P＜ 0.01),and deanxit group were better than oryzanol group(P＜ 0.01).HAMA scores in deanxit group and combination group were lower than those in oryzanol group [(8.65 ± 3.33),(7.25 ± 3.34) scores vs.(10.65 ± 3.18) scores] (P ＜0.01).Conclusion Deanxit combined with oryzanol is effective in the treatment of PSD and anxiety in elderly male.
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Title Of The Study: Effect of Deanxit Combined with Oryzanol Injection on Life Quality, Anxiety and Depression In Elderly Cerebral Patients
Objective To study the effect of deanxit combined with oryzanol injection on life quality,anxiety and depression in elderly cerebral infarction patients.Methods 90 elderly cerebral infarction patients were divided into deanxit group (27 cases)(Group A),oryzanol injection group (28 cases) (Group B) and deanxit joint oryzanol injection combined treatment group (35 cases) (Group C) according random number method during August 2012 to March 2015.Aher four weeks of treatment,life quality,anxiety and depression were compared in each group before and after treatment.Results After treatment,the score of physiological function,bodily pain,general health,vitality,social functioning,mental health,physical function,emotional function in Group A,Group B and Group C were significantly higher than before treatment (P ＜ 0.05).After treatment,the score of physiological function,body pain,general health,vitality,social functioning,mental health,physical function,emotional function in Group C were significant higher than Group A and Group B (P ＜ 0.05).The score of HAMD and HAMA after treatment in the Group C was the lowest among the three groups (P ＜ 0.05).Conclusion Deanxit combined with oryzanol injection can significantly improve the life quality and reduce patient anxiety and depression in patients wiith first elderly cerebral infarction.
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Title Of The Study: Effect of Oryzanol on Anxiety and Depression in Patients with Cerebral Infarction
Objective: To investigate the effect of oryzanol on anxiety and depression in patients with cerebral infarction. Methods: 62 cases of patients with cerebral infarction complicated with anxiety and depression admitted to our hospital from January 2016 to January 2017 were selected as subjects and divided into control group and treatment group according to different treatment methods, 31 cases in each group. The patients in the control group were given conventional therapy. The patients in the treatment group was treated with oryzanol tablet(20 mg, tid) on the basis of the control group. The changes of anxiety and depression and the clinical effects in the two groups were observed before and after treatment. Results: Before treatment, there was no significant difference in Hamilton anxiety scale(HAMA) and Hamilton depression scale(HAMD) scores between the two groups(P>0.05). After treatment, the scores of HAMA and HAMD in the treatment group were significantly lower than those in the control group(P<0.05). The total effective rate in the treatment group was 96.77%, which was significantly higher than 80.66% in the control group(P<0.05). Conclusion: Oryzanol can effectively improve anxiety and depression after cerebral infarction and play an important role in promoting disease rehabilitation and improving the quality of life, which is worthy of clinical application.
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Title Of The Study: Effectiveness of Oryzanol in Alleviating Exam-tension and Improving Students\’ Examination-adapted Ability
The medicinal effect of oryzanol in relieving exam stress was investigated, and it can provide an effective method for students to improve their ability to take exams. The subjects of the survey were randomly selected 283 second-year college students from Qufu Normal University. The quality of sleep the night before; and then let the students who are nervous about the exam take oryzanol for 3-7 days before the college English test, and the effect of oryzanol on the nervousness of the exam and the sleep disorder before the exam is calculated. At the time, 88.3% of the students felt nervous, and 59.4% of the students had varying degrees of loss on the eve of the exam…
Title Of The Study: Suanzaoren Decoction Combined with Vitamin E and Oryzanol in the Treatment of Climacteric Syndrome with Insomnia 20 Cases
Objective To analyze the effect of Suanzaoren decoction combined with vitamin E and oryzanol in the treatment of climacteric syndromewith Insomnia.Methods 40 cases of patients with climacteric syndrome in our hospital were randomly selected as the research objects.The study period was from October 2015 to October 2016.The subjects were divided into control group and observation group, and each group included 20 patients.The control group used oryzanol and vitamin E treatment, and the observation group was also given Suanzaoren decoction on the basis of the control group.The therapeutic effect of two groups was summarized.Results Comparing with the control group, the effective rate of study group was ideal.The clinical symptom score, PSQI score and therapeutic satisfaction of the study group were significantly higher than those of the control group, and there was statistical significance (P<0.05).Conclusion Suanzaoren decoction combined with vitamin E and oryzanol in the treatment of climacteric syndrome can improve the clinical symptoms, the quality of sleep and quality of life, has less adverse reaction, is conducive to the prognosis of patients, and has higher application value.
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Title Of The Study: Suanzaoren Decoction(酸枣仁汤) Combined With Flupentixol And Melitracen Tablets And Oryzanol In The Treatment Of Perimenopausal Depression Randomized Controlled Study
[Objective] To observe the Suanzaoren Decoction Combined with Flupentixol and melitracen tablets and oryzanol in the treatment of perimenopausal depression effect. [Methods] 60 outpatients were randomly divided into two groups according to the method of random parallel control. The control group of 30 cases of Flupentixol and melitracen tablets, 0.5 mg/times, 2 times/d, oral; oryzanol, 10 mg/times, 3 times/d, oral. Treatment group, 30 cases of Suanzaoren Decoction(Suanzaoren 30 g, Szechuan lovage rhizome, Poria, Anemarrhena 12 g, licorice 6 g; liver depression of the fire add gardenia, cortex moutan; phlegm heat disturbance and Rhizoma Coptidis, Trichosanthes, gardenia; Yin deficiency and fire wangka dry lotus seed, Ligustrum lucidum, Lily and Rehmannia glutinosa; due to deficiency of Qi and blood, blood Yangxin sunburn and licorice), daily 1 agent, water to cook 400 ml, 2 times daily; western medicine in the treatment of with the control group. Continuous treatment for 1 courses of 15 d. Observation of clinical symptoms, HAMD score, adverse reaction. Treatment of 1 courses of treatment(15 d), determine the efficacy. [Results] The treatment group, 8 cases recovered, 10 cases were markedly effective, 11 cases were effective, 1 case ineffective, effective rate is 96.67%; control group, 4 cases were cured, 8 cases were markedly effective, 9 cases were effective, 9 cases ineffective, efficient 70.00%. The treatment group curative effect surpasses the control group(P<0.05). HAMD score of two groups were improved(P<0.01), the treatment group improved better than the control group(P<0.01). [Conclusion] Suanzaoren Decoction Combined with droperidol thiadiazole tons and deanxit and oryzanol treatment of perimenopausal depressive disorder, and the results were satisfactory. No serious adverse reactions, worthy of promotion.
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Title Of The Study: The Efficacy Analysis of Oryzanol Combined with Anshenbunao Liquid in Neurasthenia
Objective To investigate the clinical efficacy of oryzanol combined with Anshenbunao liquid in neurasthenia.Methods 198 cases patients with neurasthenia were randomly divided into observation group and control group,each of 99 cases.Control group were treated with oryzanol treatment;Observation group were taken Anshenbunao liquid therapy on the basis of oryzanol treatment.Compared the depression score,total efficiency and adverse reactions,before and after a course of treatment for the two groups.Results After the treatment,the total effective rate of observation group(91.92%) was higher than that of control group(73.74%),the difference was statistically significant(P<0.05).The depression scale of the two groups were better than than those before treatment,there was significant difference(P<0.05).The improvement of the observation group was significantly better than control group patients,and there was statistically significant(P<0.05).Two groups during the treatment had no significant adverse reactions. Conclusion : Oryzanol combined with Anshenbunao liquid has a safe and effective advantage in the treatment of neurasthenia.It is worthy of clinical application.
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Title Of The Study: Clinical Study of Combined Therapy of ATP Etc on 36 Cases with Somatization of Pre-test Syndrome
Objective To investigate the effect of oral administration of adenosine triphosphate (ATP), oryzanol (Oryzanol) and vitamin B1 (vitamin B1) in the treatment of somatic symptoms in patients with preexisting stress syndrome. Methods A retrospective analysis was conducted to investigate the efficacy of oral administration of adenosine triphosphate (ATP), oryzanol (oryzanol) and vitaminB1 (vitamin B1). The clinical data of 36 patients treated with combined therapy were used to evaluate their clinical efficacy and adverse reactions. Results Before and after treatment, the patients were compared with anxiety scale HAMA assessment (P<0.01), sleep quality score (P<0.01), autonomic nerve function test (recumbent). (P<0.01), headache severity (P <0.01),systolic blood pressure (P<0.01), heart rate (P<0.01), there were significant differences, and the control before and after diastolic blood pressure treatment (P>0.05) There was no significant difference; no obvious adverse reactions were found. Conclusion The combination of ATP, oryzanol and vitamin B1 in the treatment of somatic symptoms caused by physiological arousal inpatients with pre-exam stress syndrome has obvious effect, and no obvious adverse reactions occurred.
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Title Of The Study: Clinical Observation on Liver and Kidney Maintenance Acupuncture Combined with Oryzanol in Treatment of
Insomnia after Ischemic Stroke
Objective To study the effect of liver and kidney conservation acupuncture combined with oryzanol on ischemic stroke insomnia. Methods 81 patients with ischemic stroke insomnia who were admitted to the Department of Neurology, Jinqiu Hospital, Liaoning Province from January 2019 to December 2020 were selected were randomly divided into the observation group and the control group by drawing lots. Forty-one patients in the control group took oryzanol tablets 30 mg orally before going to bed, and 40 patients in the observation group took oryzanol on the basis of combined use of liver and kidney conservation acupuncture. Comparison 2 The Pittsburgh Sleep fatal iM tho on sensation group m as 5 ishinzantiy higher irah that of the so hitro lto Up a P200s, Tantae the PSQI scores of the observation group were significantly lower than those of the control group(P<0.05); after treatment, SL, ASA, AT, A/TSA of the two groups were significantly decreased(P<0.05), TSA and SE were significantly increased (P<0.05). <0.05), and the sleep EEG-related indexes of the observation group were significantly better than those of the control group (P<0.05). Conclusion : Liver and kidney conservation acupuncture combined with oryzanol has a definite curative effect on ischemic stroke insomnia, not only can improve the It also helps to improve sleep EEG-related indicators, which is worthy of application and promotion.
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Title Of The Study: Clinical Effect of Oryzanol Combined with Sports Therapy in the Treatment in Patients with Neurasthenia
Objective To investigate the clinical effect of oryzanol combined with exercise therapy in the treatment of patients with neurasthenia. Methods 78 patients with neurasthenia treated in our hospital from March 2014 to March 2015 were selected and randomly divided into the control group and the observation group, 39 cases in each group, the control group The control group was given simple psychological counseling, and the observation group was given oryzanol combined with exercise therapy on the basis of the control group. After 30 days of treatment, the total effective rate, Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD)scores were compared between the two groups . Results The total effective rate (93.5%) of the observation group was higher than that of the control group (75.4%), and the difference was statistically significant (P<0.05). Before treatment, there was no statistically significant difference between the two groups of HAMA and HAMD scores (P>0.05), after treatment, the HAMA(18.21‡5.36) and HAMD (20.46+5.62) scores of the observation group were lower than those of the control group (23.68+4.36) and HAMD (24.41‡6.24), and the difference was statistically significant ( P < 0.05). Conclusion Oryzanol combined with exercise therapy is better than simple psychotherapy in the treatment of neurasthenia, and the clinical effect is significant.
