scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e024968 ◽  
Author(s):  
Mingyan Huang ◽  
Guang Chen ◽  
Qingya Guan ◽  
Chao Liu ◽  
Qing Zhao ◽  
...  

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 697-697
Author(s):  
Yasuyoshi Miyata ◽  
Kojiro Ohba ◽  
Tomohiro Matsuo ◽  
Kensuke Mitsunari ◽  
Hideki Sakai

697 Background: Royal jelly (RJ) is a honey bee product secreted from the mandibular glands and hypopharyngeal glands of worker honeybees. RJ has anti-allergy, anti-inflammatory, and immunomodulatory effects. RJ has been reported to improve the anti-cancer effects and suppress the adverse effects of chemotherapeutic agents. The main aim is to clarify the clinical effects of oral intake of RJ in renal cell carcinoma (RCC) patients treated with tyrosine kinase inhibitors (TKIs). Methods: A randomized, controlled, double-blinded clinical trial with reduction of tumor size and frequencies of adverse events as endpoints was performed in 33 RCC patients who received TKIs in Nagasaki University Hospital. Patients were divided into RJ (n = 16) and placebo (n = 17) groups, and there was no significant difference in all clinical and pathological parameters between the two groups. RJ and placebo were orally administered for 3 months. Results: In this study, 21, 8, and 3 patients were treated with sunitinib, pazopanib, and axitinib, respectively; only 1 patient was treated with sorafenib. Frequencies and severities of fatigue and anorexia in the RJ group was significantly lower than those in the placebo group ( P = 0.003 and 0.015, respectively). Such significant differences between the 2 groups were detected in patients treated with sunitinib, but not in those treated with other TKIs. The number of patients who were given an initial dose of TKIs in the RJ and placebo groups were 7 (43.8%) and 2 (11.8%), respectively, and the relative dose intensity (RDI) of the RJ group (88.6%) was significantly higher ( P = 0.016) than that in the placebo group (68.6%). Regarding anti-cancer effects, the frequency of partial response in the RJ group (n = 5; 41.7%) was higher than that in the placebo group (2; 18.2%); however, such difference was not significant ( P = 0.056). Conclusions: RJ intake can increase RDI. Although a significant difference was not observed, RJ intake observed a trend for improving anti-cancer effects by increasing RDI and maintaining quality of life.


RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001455 ◽  
Author(s):  
Maria Isabel Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Pamella Indira Menezes ◽  
...  

ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate.ResultsSeventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0–6.0) days for the colchicine group and 6.5 (4.0–9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0–9.0) days for the colchicine group and 9.0 (7.0–12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26).ConclusionColchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19.Trial registration numberRBR-8jyhxh.


2019 ◽  
Vol 8 ◽  
pp. 1350
Author(s):  
Maryam Hassanzad ◽  
Keyvan Maleki Mostashari ◽  
Hosseinali Ghaffaripour ◽  
Habib Emami ◽  
Samane Rahimi limouei ◽  
...  

Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]


Author(s):  
Maria Isabel F Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Maira N Benatti ◽  
...  

Introduction. Neutrophilia and high levels of proinflammatory cytokines and other mediators of inflammation are common finds in patients with severe acute respiratory syndrome due to COVID-19, a dramatic condition for which there is no specific treatment, but supportive care and attempts to control the systemic inflammation. By its action on leukocytes, we propose colchicine as an intervention worthy of being tested. Objective. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. Methods. We present the interim analysis of a single-center randomized, double-blinded, placebo controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 38 patients allocated 1:1 from April 11 to July 06, 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was ≥ 80 kg. Endpoints. The primary endpoints were the need for supplemental oxygen; time of hospitalization; need for admission and length of stay in intensive care unit; and death rate and causes of mortality. As secondary endpoints, we assessed: serum C-reactive protein, serum Lactate dehydrogenase and relation neutrophil to lymphocyte of peripheral blood samples from day zero to day 7; the number, type, and severity of adverse events; frequency of interruption of the study protocol due to adverse events; and frequency of QT interval above 450 ms. Results. Thirty-five patients (18 for Placebo and 17 for Colchicine) completed the study. Both groups were comparable in terms of demographic, clinical and laboratory data at baseline. Median (and interquartile range) time of need for supplemental oxygen was 3.0 (1.5-6.5) days for the Colchicine group and 7.0 (3.0-8.5) days for Placebo group (p = 0.02). Median (IQR) time of hospitalization was 6.0 (4.0-8.5) days for the Colchicine group and 8.5 (5.5-11.0) days for Placebo group (p = 0.03). At day 2, 53% vs 83% of patients maintained the need for supplemental oxygen, while at day 7 the values were 6% vs 39%, in the Colchicine and Placebo groups, respectively (log rank; p = 0.01). Hospitalization was maintained for 53% vs 78% of patients at day 5 and 6% vs 17% at day 10, for the Colchicine and Placebo groups, respectively (log rank; p = 0.01). One patient per group needed admission to ICU. No recruited patient died. At day 4, patients of Colchicine group presented significant reduction of serum C-reactive protein compared to baseline (p < 0.001). The majority of adverse events were mild and did not lead to patient withdrawal. Diarrhea was more frequent in the Colchicine group (p = 0.17). Cardiac adverse events were absent. Discussion. The use of colchicine reduced the length of both, supplemental oxygen therapy and hospitalization. Shortly less than half of the patients of the Colchicine group stopped receiving supplemental oxygen until day 2. Clinical improvement was in parallel with a reduction on serum levels of C-reactive protein. The drug was safe and well tolerated. Colchicine may be considered a beneficial and not expensive option for COVID-19 treatment. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalized patients with moderate to severe COVID-19.


2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Lijing Yan ◽  
Lijin Yu ◽  
Linlin Zhao ◽  
Dongsheng Wang ◽  
Dilan Qin ◽  
...  

Background. FD (functional dyspepsia) is a common functional gastrointestinal disorder, which lacks effective and safe treatment. Chinese herbal medicine (CHM) has been applied in FD treatment for thousands of years with satisfactory clinical outcomes. Zhishi is a classical traditional Chinese medicine used to treat FD. Weikang pian (WKP) is made of flavonoids extracted from zhishi which could effectively alleviate the symptoms of FD. This research aimed to assess the efficacy and safety of WKP in FD treatment. Methods. This was a randomized, double-blinded and placebo-controlled clinical trial. The patients were diagnosed as FD according to RomeIII criteria. Then, FD patients were selected and assigned randomly to either WKP or placebo group. The subjects randomly received WKP or placebo for 4 weeks with 4 tablets each time, 3 times daily. The single dyspepsia symptom (SDS) scale and the gastric emptying function were measured before and after the treatment. Moreover, the safety of the trial and patient compliance were evaluated. Results. A total of 60 FD patients were eventually enrolled in the trial, among them 45 patients in the WKP group and 15 patients in the placebo group. The primary outcome was the SDS scale, including assessments of postprandial distension, early satiety, epigastric burning, and pain. The secondary outcome was the gastric emptying function. Compared with the placebo group, the symptoms of FD in the WKP group were relieved after 4 weeks of treatment (P<0.05). Some minor changes appeared in the four groups, but there were no significant differences in gastric emptying parameters of GER (2-hour gastric emptying rate) and GET/2 (gastric semiempty time) (P>0.05). Severe adverse events were absent. The compliance to treatment was 94%–96%, and there was no significant difference between the groups. Conclusion. WKP can relieve FD symptoms to some extent. This trial is registered with Chinese Clinical Trial Registry (ChiCTR): CTR 20132482.


2020 ◽  
Vol 9 (7) ◽  
pp. 2173
Author(s):  
Eun Yeong Lim ◽  
So-Young Lee ◽  
Hee Soon Shin ◽  
Jaekwang Lee ◽  
Young-Do Nam ◽  
...  

This study evaluated the efficacy of Lactobacillus acidophilus YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40–60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 108 CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms—physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.


2020 ◽  
Vol 17 (5) ◽  
pp. 696-703 ◽  
Author(s):  
Vahid Tafazoli ◽  
Mahdi Shahriari ◽  
Mojtaba Heydari ◽  
Hosein Ali Nikbakht ◽  
Mohammad M. Zarshenaas ◽  
...  

Introduction: Finding non-systemic antipyretic option in cancer patients who simultaneously receive several other drugs seems be logical. This study was designed to evaluate complementary therapy with Viola odorata L. oil for fever control in febrile neutropenic children. Methods and Materials: In a randomized placebo controlled clinical trial, 41 febrile children were divided into two groups. Children in the active drug group received viola oil (20 drops) to be rubbed on the peripheral margin of the patient umbilicus. Primary outcome measure of the study was the mean axillary temperature in the 30, 60, and 240 minutes after the intervention. Results: The mean temperature reduced significantly in the viola group after 30 minutes of administration (p =0.005), while there was no significant change in the placebo group (p =1.00). The number of patients who received paracetamol as the rescue treatment was significantly lower in the viola group than that in the placebo group (5 vs. 17, p =0.001). Conclusion: The results of our study showed the safety and efficacy of complementary therapy with Viola odorata L. oil for fever control in febrile neutropenic children during hospital course.


2021 ◽  
Vol 6 (2) ◽  
pp. 1-6
Author(s):  
Kafrouni HF

Background: Perioperative hypothermia has been strongly associated with poor outcomes in children undergoing general anesthesia. Methods: This study consisted of a monocentric, block randomized, double blinded, placebo-controlled clinical trial over a period of 3 months at a tertiary referral center. Non-febrile patients with no significant medical history younger than 3 years and having surgery for a minimum duration of one hour under General Anesthesia were chosen. Thirty minutes prior to emergence, patients received either IV Acetaminophen (Group P) or a placebo solution of normal saline (Group N). The temperature was recorded at T0, T15, T30, T45 and T60 intervals. Results: 60 out of 84 patients were enrolled, the sample consisted of 58.3% (n=35) males and 41.7% (n=25) females with a mean age 1.16 ± 0.92 years. When using a t test to compare the mean core temperature, at a 95% Confidence Interval and ±=0.05, data showed that in Group P (35.52 ±0.68 oC < 36°C) and in Group N (36.07 ±0.71 oC > 36°C) were significantly different at T30 (p<0.005). A similar significance was observed at T45 yet not at T60. Conclusion: Acetaminophen seems to have induced a significant transient hypothermia at T30 in the pediatric population, which coincides in this study with the critical time of emergence. At T60, no significant difference was observed, suggesting that patients’ core body temperature values returned to normality. Therefore, it is recommended to administer Acetaminophen at least 60 minutes prior to emergence to avoid a core temperature drop during this critical phase.


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