scholarly journals Efficacy of Jinhua Qinggan Granules Combined With Western Medicine in the Treatment of Confirmed and Suspected COVID-19: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
XueDong An ◽  
Xi Xu ◽  
MingZhong Xiao ◽  
XiaoJun Min ◽  
Yi Lyu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Western Medicine ◽  
Clinical Symptoms ◽  
Antiviral Drugs ◽  
Symptom Improvement ◽  
Control Group ◽  
Poor Appetite ◽  
Randomized Controlled ◽  
Conversion Rates ◽  
Significant Difference

Objective: To conduct a randomized controlled clinical trial to evaluate the clinical efficacy and prognostic value of Jinhua Qinggan granules in patients with confirmed and suspected coronavirus disease 2019 (COVID-19).Methods: A total of 123 suspected and confirmed COVID-19 patients participated in this clinical trial and were randomly divided into Jinhua and Western medicine groups. For 14 days, the Jinhua group was treated with Jinhua Qinggan granules and antiviral drugs, and the Western medicine group was treated with antiviral drugs alone. We collected information on clinical symptoms, disease aggravation rates, and negative conversion rates of nucleic acids in patients, and observed the effects of anti-infective drugs.Results: There was no significant difference in symptom improvement rates between the two groups, both confirmed and suspected patients (P > 0.05). Both treatments relieved symptoms such as fever, fatigue, and diarrhea. However, the Jinhua treatment was superior in relieving fever and poor appetite. Anti-infective drug use rates were significantly lower in the Jinhua group than in the control group.Conclusion: Jinhua Qinggan granules combined with Western medicine could relieve the clinical symptoms of fever and poor appetite in COVID-19 patients, reduce the use of antibiotics to a certain extent.Clinical Trial Registration: The registration number at China Clinical Trial Registry is ChiCTR2000029601.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals "Heterozygous Treatment" Method to Improve the Biased Status of the Damp-heat Constitution and Symptom Integral: Randomized Controlled Trial

2018 ◽  
Vol 1 (1) ◽  
pp. 33
Author(s):  
Xianbing Hou ◽  
Haizhang Wang ◽  
Yanzhen Huo ◽  
Hui Zhao
Keyword(s):  
Clinical Symptoms ◽  
Controlled Trial ◽  
Treatment Method ◽  
Control Group ◽  
Observation Group ◽  
Randomized Controlled ◽  
Dark Urine ◽  
Significant Difference ◽  
Before And After ◽  
And Control

Objective: To observe the clinical effect of "heterozygous treatment" intervening the damp-heat constitution. Method: 106 cases with damp-heat constitution were randomly divided into the observation group and control group, 53 cases for each group. Lianpu drink was given to the two groups, and the observation group was treated with scraping, acupuncture, cupping, constitution care and popularization of constitution science for "heterozygous treatment" based on the control group. 70 days later, "constitution classification and determination table of traditional Chinese medicine" was used to determine, and statistics was applied to analyze the change of the symptoms of the two groups before and after the intervention. Results: in the observation group, compared to before the intervention, symptoms like dirty and oily complexion, yellow greasy tongue, bitter taste, dullness and scanty dark urine were significantly improved (P < 0.05), and improvement of the above symptoms was greater than the control group (P < 0.05) .Conclusion: There is no significant difference between the two groups (P > 0.05). Conclusion: the "heterozygous treatment" method can significantly improve the clinical symptoms of people with damp-heat constitution, with a better role in regulating.

scholarly journals Ultra-short-wave diathermy shortens the course of moderate and severe COVID-19: a randomized controlled trial

2021 ◽  
Author(s):  
Liangjiang Huang ◽  
Qian Li ◽  
Sayed Zulfiqar Ali Shah ◽  
Mohammad Nasb ◽  
Chen Bin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pulmonary Fibrosis ◽  
Lung Injury ◽  
Statistical Significance ◽  
Small Sample ◽  
Control Group ◽  
Clinical Recovery ◽  
Randomized Controlled ◽  
Conversion Rates ◽  
Negative Conversion

AbstractBackgroundCOVID-19 patients have severe lung injury. The USWD could play a supportive role in relieving lung injury and enhance clinical recovery.Methods and findingsThe design was a single-center, evaluator blinded; 2-arm parallel design superiority randomized controlled clinical trial. Moderate and severe coronavirus-2 (SARS-CoV-2) positive patients with acute respiratory syndrome, Fifty patients were randomized (USWD, 25; control, 25) between February 18/2020 and April 20/2020. There were male 22 (44.0%) and female 28 (56.0%) with mean (SD) age 53(10.69). Time to clinical recovery (USWD 36.84 vs control 43.56, P = 0.03) was significantly shortened with a between-group difference of 6.72 days. The median SIRS score at day 28 was 0 (0-1) in the USWD group, while 0 (0-2) in the control group (P = 0.011), and the seven-point scale at day 28 showed significant improvement in the USWD group (P = 0.003). While the rate of RNA negative conversion at day 7 (2/25 vs 7/25, p=0.054), day 14 (14/25 vs 18/25 p=0.239), day 21 (22/25 vs 18/25 p=0.279), and day 28 (25/25 vs 22/25 p=0.730) did not show statistical significance. Similarly, no significant differences were observed in the AI-assisted CT analysis. No treatment-associated adverse events or worsening of pulmonary fibrosis were found.ConclusionsAmong the 50 moderate and severe COVID-19 patients, the USWD as an adjunctive therapy to standard therapy could shorten the recovery course and enhance clinical improvement without aggravating pulmonary fibrosis. However, the study did not report statistical significance in the negative conversion rates of SARS-CoV-2 nucleic acid due to the small sample size and early termination, the findings of this study are limited.TRIAL REGISTRATIONChinese Clinical Trial Registry: ChiCTR2000029972, URL: http://www.chictr.org.cn/historyversionpuben.aspx?regno=ChiCTR2000029972

scholarly journals The use of a mouthwash and a dentifrice containing antimicrobial phthalocyanine derivative on the reduction of clinical symptoms of COVID-19: A randomized triple-blinded clinical trial

2021 ◽  
Author(s):  
Marcelo Lupion Poleti ◽  
Danielle Gregório ◽  
Alisson Gabriel Idelfonso Bistaffa ◽  
Karen Barros Parron Fernandes ◽  
Fabiano Vieira Vilhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chest Pain ◽  
Sore Throat ◽  
Clinical Symptoms ◽  
Nasal Congestion ◽  
Control Group ◽  
Shortness Of Breath ◽  
Significant Difference ◽  
Hoarse Voice ◽  
Phthalocyanine Derivative

Abstract PurposeThis clinical trial aimed to evaluate the use of a mouthwash and a dentifrice containing antimicrobial phthalocyanine derivative (APD) on the reduction of clinical symptoms in COVID-19 patients.MethodsThis randomized triple-blinded clinical trial enrolled 500 patients aged 18 years or older submitted to COVID-19 test by nasopharyngeal swab RT-qPCR in a reference center for the diagnosis of COVID-19, had no clinical contraindications to perform mouthwash and gargle, and had access to cell phone with communication application. Patients were randomly assigned (1:1) to use a mouthwash, and a dentifrice both containing antimicrobial phthalocyanine derivative (APD Group) or Non-APD (Control Group). All participants were instructed to floss twice a day, toothbrushing during 2 minutes/three times a day, and for gargling/rising (5ml) during 1 minute/three times a day for 7 days. An online questionnaire was sent to collect the clinical symptoms of COVID-19 in three times: T0 (baseline - before using the oral hygiene products); T3 (three days after); and T7 (seven days after). The investigators, patients, and outcomes assessor were blinded to group assignment. Mann-Whitney test, Chi-Square test, Exact Fisher test, and Cochran’s test were used according to the nature of the variables studied, with the level of significance set at P < 0.05.ResultsNo statistically significant difference was found in the prevalence of symptoms between the groups at baseline. A statistically significant reduction of clinical symptoms was found in the Control Group (fatigue, shortness of breath, hoarse voice, sore throat, nasal congestion, and chest pain) and in APD Group (cough, fatigue, shortness of breath, hyposmia/anosmia, dysgeusia, hoarse voice, sore throat, nasal congestion, chest pain, diarrhea and irritability/confusion) during the follow-up period. There were statistically significant differences with a higher symptoms’ prevalence for the Control Group at T3 and T7. Dysgeusia, sore throat, irritability/confusion was less prevalent at the APD Group at T3, and shortness of breath, hyposmia/anosmia, dysgeusia, hoarse voice, sore throat, diarrhea, and irritability/confusion were more prevalent in the Control Group at T7.ConclusionsBased on methodology, the results demonstrated that the regular use of mouthwash and dentifrice containing APD had a positive impact on the clinical symptoms reported by COVID-19 patients.

scholarly journals The Effect of Intravenous Tranexamic Acid on Hemoglobin and Hematocrit Levels After Cesarean Delivery: a Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Esmat Jafarbegloo ◽  
Faride Faridnyia ◽  
Atefeh sadat mohammad hoseini nejad
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Tranexamic Acid ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hematocrit Level ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Novel Approach ◽  
Significant Difference

Abstract Background: During a cesarean section, the mother loses a lot of blood. This bleeding can cause a drop in hemoglobin and hematocrit. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to explore the effect of intravenous tranexamic acid on hemoglobin and hematocrit level after cesarean section(CS) in women who were low risk in postpartum hemorrhage.Methods: This prospective randomised placebo-controlled clinical trial was carried out on 50 pregnant women referred to Izadi hospital, Qom, Iran, 2017. women were divided into two groups of 25 cases using block randomization. The study group, 25 women, received tranexamic acid 10 minutes before CS whereas the control group, 25 women received distilled water. Hemoglobin and hematocrit levels were measured before and 12-24 hours after delivery. Results: There was no significant difference in pre-operative and 12-24 h post-operative hemoglobin and hematocrit levels between the two groups(p>0.05). Conclusions: Pre-operative prescription of 1gr tranexamic acid was not associated with improvement of post-operative hemoglobin and hematocrit.Trial registration: IRCT20091010002558N7.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

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