Effect of nigella sativa oil sup plementation on kidney function tests, glycemic parameters, oxidative stress, inflammation, quality of life and depression status in diabetic hemodialysis patients; study protocol for a double-blind, randomized controlled trial

2021 ◽  
Author(s):  
Alireza Rahmani ◽  
Ali Tarighat-Esfanjani ◽  
Bahram Niknafs ◽  
Omid Mohammad Tavakoli-Rouzbehani ◽  
Vahid Maleki
Keyword(s):  
Quality Of Life ◽  
Oxidative Stress ◽  
Randomized Controlled Trial ◽  
Nigella Sativa ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Kidney Function Tests ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background and objectives: The kidney is probably the most crucial target of microvascular damage in diabetes, which can ultimately eventuate end-stage renal disease (ESRD). Hemodialysis is the most usual way of renal replacement therapy in ESRD. Patients receiving hemodialysis are susceptible to many complications like hyperglycemia, inflammation, depression, anxiety, and poor quality of life. So, they constrained to consume many drugs. Medicinal herbs are used in different cultures as a reliable source of natural remedies. This study aims to determine the efficacy of Nigella sativa (NS) oil supplementation on blood glucose, kidney function tests, inflammation, oxidative stress, quality of life, and depression in hemodialysis patients.Methods and analysis: This double-blind, randomized controlled trial will enroll 46 patients with diabetes mellitus who give hemodialysis thrice a week. Patients who have an inflammatory or infectious disease, and who receiving nonsteroidal anti-inflammatory drugs, will be excluded. Patients will be randomized to the treatment and control group, which will be recommended using two soft gel of NS and paraffin oil, respectively. Laboratory tests will be assessed at baseline and end of the study, including fasting blood sugar, glycated albumin, insulin, creatinine, blood urea nitrogen, urea, uric acid, superoxide dismutase, malondialdehyde, total antioxidant capacity, high sensitive C reactive protein, and 24-hour urine volume. Also, the kidney disease and quality of life and hospital anxiety and depression scale questionnaires will be evaluated.Ethics and dissemination: According to our knowledge no sever adverse effect have been reported. The protocol was found to be in accordance to the ethical principles and national norm standard for conducting medical research in Iran (IR.TBZMED.REC.1399.109). Both positive and negative findings will be reported.Trial registration: Iranian registry of clinical trials: IRCT20200411047027N1. Registered on 31 may 2020, https://fa.irct.ir/user/trial/48113/view

scholarly journals Chinese phytotherapy to reduce stress, anxiety and improve quality of life: randomized controlled trial

2016 ◽  
Vol 50 (5) ◽  
pp. 853-860 ◽  
Author(s):  
Leonice Fumiko Sato Kurebayashi ◽  
Ruth Natalia Teresa Turrini ◽  
Gisele Kuba ◽  
Miki Hoshi Minamizawa Shimizu ◽  
Raymond Sehiji Takiguch
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Improve Quality ◽  
Double Blind ◽  
Randomized Controlled ◽  
Stress Levels ◽  
The Difference ◽  
Post Hoc

Abstract OBJECTIVE To evaluate the effect of Chinese phytotherapyto reduce stress levels, anxiety and improve quality of life. METHOD double-blind randomized controlled trial with 89 volunteers divided into three groups: control (no intervention), Placebo and Phytotherapy. The study was conducted in 2015 with healthy adults treated at the Integrated and Eastern Therapy Institute,in Sao Paulo, Brazil. Participants were evaluated at baseline and after three weeks with the Stress Symptoms List (SSL), Anxiety Inventory-Trait and State and SF12v2 for quality of life. Intervention groups received a placebo or Gan May Zao formula (GMDZ)flaskwith 50 ml. RESULTS According to ANOVA, there were significant differences (p = 0.025) after treatment of stress (SSL2). And the difference was between control and Phytotherapy groups, according to the Tukey post hoc (p = 0.022). There were no differences in the levels of state-anxiety and physical and mental domains in the SF12v2. CONCLUSION The GMDZ formula reduced stress levels, but more studies are needed with greater sample, with reassessment of dosage and a longer period of treatment to confirm and extend the results. Brazilian Registry of Clinical Trials: RBR-28s4hz.

scholarly journals Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Yu-Wei Chang ◽  
Tsia-Shu Lo ◽  
Hsin-Ning Chang ◽  
Yi-Hsien Shiao ◽  
Yuan-Chieh Yeh
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Overactive Bladder ◽  
Controlled Trial ◽  
Laser Acupuncture ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Experimental Group

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

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