Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

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Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

10.21203/rs.3.rs-361628/v1 ◽

2021 ◽

Author(s):

xiaochen Yang ◽

Xingjiang Xiong ◽

Yun Zhang ◽

Yongmei Liu ◽

Hongzheng Li ◽

...

Keyword(s):

Blood Pressure ◽

Inflammatory Responses ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo ◽

Medium Risk ◽

Tcm Syndrome ◽

And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

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Intravenous methylcobalamin effectively ameliorated painful diabetic neuropathy: A randomized double-blind placebo controlled trial

Romanian Journal of Neurology ◽

10.37897/rjn.2021.3.12 ◽

2021 ◽

Vol 20 (3) ◽

pp. 335-341

Author(s):

Thomas Eko Purwata ◽

◽

I Putu Eka Widyadharma ◽

Made Rudy ◽

Andreas Soejitno ◽

...

Keyword(s):

Treatment Group ◽

Diabetic Neuropathy ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

Painful Diabetic Neuropathy ◽

Double Blind ◽

Entire Study ◽

Double Blind Placebo ◽

And Control

Objective. Painful diabetic neuropathy (PDN) is a prevalent debilitating consequence of diabetes mellitus with lack of satisfactory therapeutic options. Methylcobalamin (MeCbl) is one of vitamin B12 analogs with known neurotrophic effects. We aimed to determine if MeCbl can relieve PDN. Materials and methods. This was a randomized (1:1) double-blind placebo-controlled trial involving PDN patients. Treatment and control group received daily 12.5 mg oral amitriptyline bid with either 500 µg of intravenous MeCbl or saline injection given on alternating days, respectively, for a 9-consecutive day period. PDN was assessed with douleur neuropathique 4 (DN4) questionnaire. Numeric pain rating scale (NPRS) was used to monitor pain intensity and treatment response. All investigators and patients were kept blinded throughout the study period. Outcomes. 42 patients, 21 on each arm had completed the study. The NPRS reduction can already be observed as early as day 2 post-intervention. Both the treatment and control group demonstrated sustained reduction of NPRS by almost one point per each time point of evaluation in the first three days (p<0.001). NPRS reduction remained until the end of the study period. The treatment group had a significantly lower NPRS score by 1.29 than that of the control group during the entire study period (95% CI -1.84 – -0.75; p < 0.001). Treatment group experienced significantly higher NPRS reduction when compared with control (4.19±1.54 vs. 2.1± 0.83; 95% CI 1.32-2.87; p < 0.001), i.e. 62.6% from baseline. Conclusions. MeCbl significantly and safely relieved PDN in a relatively rapid onset.

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Effectiveness of Intravenous Ibuprofen On Emergence Agitation in Children Undergoing Tonsillectomy With Propofol Anesthesia: A Double-Blind, Placebo-Controlled, Randomized Study

10.21203/rs.3.rs-1009839/v1 ◽

2021 ◽

Author(s):

Zhengzheng Gao ◽

Jianmin Zhang ◽

Xiaolu Nie ◽

Xiaohuan Cui

Keyword(s):

General Anesthesia ◽

Protective Factor ◽

Pediatric Anesthesia ◽

Controlled Study ◽

Control Group ◽

Emergence Agitation ◽

Double Blind ◽

Double Blind Placebo ◽

High Pain Score ◽

Intravenous Ibuprofen

Abstract Background: Emergence agitation (EA) has a negative effect on recovery from general anesthesia in children. Objectives: This study aimed to evaluate the effectiveness of intravenous ibuprofen in reducing the incidence of EA in children.Methods: This randomized, double-blind, placebo-controlled study analyzed data from patients aged 3–9 years undergoing tonsillectomy with propofol general anesthesia. These patients were randomly assigned to receive either the ibuprofen or the placebo intraoperatively. The primary endpoint was between-group difference in the incidence of EA after surgery. EA was defined as Pediatric Anesthesia Emergence Delirium score ≥ 10. The secondary endpoint included the associated factors of EA.Results: Eighty-nine patients were included in the study. Ibuprofen decreased the incidence of EA (8.9% in the treatment group vs. 34.1% in the control group; odds ratio [OR], 0.261; 95% confidence interval [CI], 0.094–0.724; P = 0.004). After the logistic regression analysis, anxiety behavior pre-anesthesia and high pain score after surgery were the risk factors related to EA (OR, 8.07; 95% CI, 1.12–58.07, P = 0.038 and OR, 2.78; 95% CI, 1.60–4.82, P < 0.001, respectively). Ibuprofen administration was the protective factor related to EA (OR, 0.05; 95% CI, 0.01–0.67, P = 0.023).Conclusions: In our studied cohort, intraoperatively infusing ibuprofen and relieving preoperative anxiety and postoperative pain can significantly reduce the incidence and severity of EA after propofol general anesthesia.Trial registration: ChiCTR2100045128 (07/04/2021)

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Effect of a Growing-up Milk Containing Synbiotics on Immune Function and Growth in Children: A Cluster Randomized, Multicenter, Double-blind, Placebo Controlled Study

Clinical Medicine Insights Pediatrics ◽

10.4137/cmped.s13073 ◽

2013 ◽

Vol 7 ◽

pp. CMPed.S13073 ◽

Cited By ~ 4

Author(s):

Ninh Nguyen Xuan ◽

Dantong Wang ◽

Dominik Grathwohl ◽

Phuong Nguyen Thi Lan ◽

Hoa Vu Thi Kim ◽

...

Keyword(s):

Immune Function ◽

Vitamin A Deficiency ◽

Test Group ◽

Child Growth ◽

Controlled Study ◽

Control Group ◽

Growing Up ◽

Double Blind ◽

Double Blind Placebo ◽

Cluster Randomized

Common infectious diseases, such as diarrhea, are still the major cause of death in children under 5-years-old, particularly in developing countries. It is known that there is a close relationship between nutrition and immune function. To evaluate the effect of a growing-up milk containing synbiotics on immune function and child growth, we conducted a cluster randomized, multicenter, double-blind, placebo controlled clinical trial in children between 18 and 36 months of age in Vietnam. Eligible children from eight and seven kindergartens were randomly assigned to receive test and isocaloric/isoproteic control milk, respectively, for 5 months. We found that the blood immunoglobulin A (IgA) level and growth parameters were increased in the test group. Compared to the control group, there was also a trend of decreased vitamin A deficiency and fewer adverse events in the test group. These data suggest that a growing-up milk containing synbiotics may be useful in supporting immune function and promoting growth in children.

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Treatment of acute respiratory viral infections: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

Infekcionnye bolezni ◽

10.20953/1729-9225-2020-3-178-189 ◽

2020 ◽

Vol 18 (3) ◽

pp. 178-189

Author(s):

V.V. Rafalsky ◽

◽

R.F. Khamitov ◽

T.I. Martynenko ◽

M.V. Chernogorova ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Viral Infections ◽

Wilcoxon Test ◽

Controlled Study ◽

Control Group ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Respiratory Viral Infections

This multicenter, double-blind, placebo-controlled clinical trial was conducted to obtain additional data on the efficacy and safety of Anaferon for the treatment of acute respiratory viral infections (ARVI) during seasonal increase in their incidence (RCT of the Ministry of Health of Russia No 356 dated 24.07.2018; ClinicalTrials.gov Identifier: NCT03707912). Patients and methods. Between October 2018 and March 2019, a total of 204 patients aged 18 to 70 years with ARVI symptoms were included in this study within the first 24 hours of symptom onset. Patients were randomized into 2 groups: 104 individuals received oral Anaferon (should be kept in the mouth until completely dissolved and without food) according to the following scheme: 1 tablet every 30 minutes during the first 2 hours; then 3 more doses at regular intervals during the first day; then 1 tablet 3 times a day on days 2–5; 100 individuals received placebo according to the same scheme. The primary endpoint was time to resolution of symptoms of clinically diagnosed and/or PCR (polymerase chain reaction) – confirmed ARVI. Addithional endpoints included: time to resolution of symptoms of ARVI confirmed by PCR; proportion of patients with resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI and separately PCR-confirmed ARVI; severity of clinically diagnosed and/or PCR-confirmed ARVI (assessed by ‘area under the curve’ for the total severity index); the number of antipyretic doses taken according to indications on days 1–3 of treatment (checked in the patient's diary); proportion of patients who required antibiotic treatment on days 4–7 of follow-up. To assess safety, we analyzed the incidence and type of adverse events (AEs), their severity, association with drug use, and treatment outcome. The following statistical methods were used: Fisher's exact test, Cochran–Mantel–Haenszel test, Wilcoxon test, and repeated measures ANOVA, PROC MIXED. Results. A total of 203 patients were included in the intention-to-treat (ITT) and per protocol (РР) analysis: 103 [95] individuals in the Anaferon arm and 100 [93] individuals in the Placebo arm. Patients receiving Anaferon had significantly shorter time to resolution of all ARVI symptoms than patients receiving placebo: 4.1 ± 1.6 days vs 4.5 ± 1.5 days (p = 0.032). The disease was on average 1 day shorter in patients from the experimental group compared to controls: 3.6 ± 1.5 days vs 4.6 ± 1.5 days (p = 0.007). The proportion of patients who had resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI was significantly higher in the Anaferon arm compared to Placebo arm (p = 0.0012). Among patients with PCR-verified ARVI, treatment with Anaferon resulted in twice as frequent recovery as in the control group on day 4 (53.7% vs 26.3%) and day 7 (70.7% vs 36.8%). In the Anaferon arm, we observed shorter disease duration and higher proportion of patients recovered compared to the Placebo arm; however, patients in both groups had a similar need for antipyretic drugs on days 1–3 of treatment, as well as for antibiotic therapy. The incidence of AEs in the Anaferon and Placebo groups did not vary significantly. No AEs with a reliable association with Anaferon were registered. Conclusion. Our findings suggest high efficacy and safety of Anaferon in patients with ARVI. The best results were obtained in patients with PCR-verified diagnosis, which can be attributed to the involvement of the interferon system in the action of the drug. The results of this RCT confirm the data obtained in previous studies and long-term clinical experience of using Anaferon. Key words: acute respiratory viral infections, ARVI, treatment, effective therapy, placebo-controlled study, Anaferon, randomized clinical trial, comprehensive therapy, efficacy, safety

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The Efficacy of Mindfulness-Based Alzheimer’s Stimulation (Mbas) in the Progression of Cognitive Impairment: A Double-Blind, Randomized Clinical Trial

European Journal of Investigation in Health, Psychology and Education ◽

10.3390/ejihpe4020009 ◽

2014 ◽

Vol 4 (2) ◽

pp. 101-112

Author(s):

Domingo Jesús Quintana Hernández ◽

María del Pino Quintana Montesdeoca

Keyword(s):

Clinical Trial ◽

Cognitive Impairment ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Cognitive Stimulation ◽

Mindfulness Practice ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

And Control

We conducted a randomized, controlled study in order to investigate the feasibility, security as well as the effects of the practice of mindfulness upon the evolution of AD. The efficacy of a Mindfulness-based Cognitive Stimulation program for Alzheimer’s patients was tested in this double-blind, randomized clinical trial, using repeated measures of CAMDEX (CAMCOG y MMSE) every six months during two years. A total of 168 patients, presenting a Probable Alzheimer Disease according to NINCDS-ADRDA criteria and treated with donepezil, were randomly assigned to the four following non-pharmacological treatments: standard cognitive stimulation, progressive muscular relaxation, mindfulness-based Alzheimer stimulation and control group, which received no intervention. Each experimental group worked in 90-minute sessions, three times per week during two years (a total of 96 weeks). Results indicated that the Mindfulness-based Alzheimer Stimulation group did not show as much a significant decline of cognitive function as the other groups did. Therefore, it seems that mindfulness practice, as implemented in this program, can have a preventive role against the progression of cognitive impairment in AD. These results support the use of mindfulness as a non-pharmacological treatment.

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Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Trials ◽

10.1186/s13063-022-05999-2 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Xiaochen Yang ◽

Lanping Liu ◽

Xingjiang Xiong ◽

Yun Zhang ◽

Yongmei Liu ◽

...

Keyword(s):

Blood Pressure ◽

Inflammatory Responses ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Clinical Trial Registry ◽

Double Blind ◽

Double Blind Placebo ◽

Medium Risk ◽

Tcm Syndrome

Abstract Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019

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Efficacy and Safety of the Cudrania tricuspidata Extract on Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Multicenter Study

Journal of Clinical Medicine ◽

10.3390/jcm10225323 ◽

2021 ◽

Vol 10 (22) ◽

pp. 5323

Author(s):

Jinyoung Shin ◽

Tae-Hoon Oh ◽

Joo-Yun Kim ◽

Jae-Jung Shim ◽

Jung-Lyoul Lee

Keyword(s):

Functional Dyspepsia ◽

Rating Scale ◽

Gastrointestinal Symptoms ◽

Controlled Study ◽

Caffeine Intake ◽

Control Group ◽

Double Blind ◽

Cudrania Tricuspidata ◽

Double Blind Placebo ◽

Folk Remedy

Cudrania tricuspidata is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of Cudrania tricuspidata extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, double-blind, placebo-controlled study, 100 adults with any condition featured in the Rome IV criteria and a Gastrointestinal Symptoms Scale (GIS) score ≥4 were randomly allocated to take either a placebo (maltodextrin) or a 50 mg CTE tablet, which equally included celluloses, magnesium stearate, and silicon dioxide, twice daily, 20 January 2020, and 3 August 2020. Among the 83 participants finally analyzed, the CTE group was associated with a significant reduction in the gastrointestinal symptom rating scale (day 0: 8.0 ± 5.2, day 28: 4.7 ± 3.9, and day 56: 2.3 ± 2.4, p < 0.001, respectively) in comparison with the control group (day 0: 8.1 ± 4.7, day 28: 7.8 ± 5.7, and day 56: 7.5 ± 6.6, p > 0.05) after adjusting for smoking, drinking, eating habits, stress levels, and caffeine intake. The CTE group resulted in significant improvements of GIS, Nepean Dyspepsia Index (Korean version), and functional dyspepsia-related quality of life over time. There were no different adverse events (p = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.

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The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽

10.3390/nu12102940 ◽

2020 ◽

Vol 12 (10) ◽

pp. 2940

Author(s):

Marina Perić ◽

Dominique Maiter ◽

Etienne Cavalier ◽

Jérôme F. Lasserre ◽

Selena Toma

Keyword(s):

Vitamin D ◽

Vitamin D3 ◽

Test Group ◽

Controlled Study ◽

Control Group ◽

Controlled Clinical Trial ◽

Pocket Depth ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

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Antihyperglycemic Effect of Fenugreek and Ginger in Patients with Type 2 Diabetes: A Double-Blind, Placebo-controlled Study

Current Nutrition & Food Science ◽

10.2174/1573401317666210706121806 ◽

2021 ◽

Vol 17 ◽

Author(s):

Mohamed A. Elsaadany ◽

Hussah M. AlTwejry ◽

Rwabi A. Zabran ◽

Sara A. AlShuraim ◽

Wala'a A. AlShaia ◽

...

Keyword(s):

Type 2 Diabetes ◽

Glycemic Control ◽

Lipid Profile ◽

Conventional Medicine ◽

The Other ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo

Background: Type 2 diabetes mellitus (T2DM) is a worldwide chronic, complex, and progressive disease that usually requires combination therapy for improved glycemic control. Although conventional medicine showed more potency than herbal medicine, a combination of both may result in better therapeutic outcomes with fewer side effects. Objective: This study was conducted to investigate the antihyperglycemic potential of fenugreek seeds (Trigonellafoenum-graecum L.) and ginger root (Zingiber officinalis), in patients with T2DM along with their usual antidiabetic medications. Methods: A double-blind, placebo-controlled study was conducted using 33 cases who were randomly divided into three groups. The first group received oral placebo capsules (1 g 3 times a day) and served as a control group, while the other two groups each received capsules of either fenugreek or ginger powder of the same dosage (1 g 3 times a day). The study was conducted for 8 weeks and treatment effects in patients were assessed through the measurements of serum’s fasting blood sugar (FBS), HbA1c, lipid profile as well as kidney and liver functions. Results and Discussion: After 8 weeks of intervention, fenugreek and ginger induced a significant reduction in FBS by 19.1±3.8% and 16.0±8.0% compared to their baselines, respectively (P≤0.05). Moreover, fenugreek significantly reduced HbA1c by 15.9±4.9% compared to the baseline, while ginger did not. Creatinine and triglyceride levels were also reduced significantly (P≤0.05) compared to their baselines in both fenugreek and ginger groups. However, all the other parameters did not significantly change. Conclusion: This study provides evidence that using fenugreek and ginger may enhance glycemic control in T2DM patients. Additionally, they might improve kidney function and lipid profile.

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