A randomized-controlled pilot study on the effects of naproxen for the treatment of bleeding and spotting among new Copper T 380A IUD users

Abstract Background: The most common reason women report discontinued use of the Copper T 380A (TCu380A) IUD is because of bleeding irregularities after method initiation. The objective of this study was to determine whether an over-the-counter NSAID, naproxen sodium, reduces the number of bleeding and spotting days and heavy or prolonged bleeding episodes among new users of the TCu380A IUD compared to placebo.Methods: In this double-blind pilot trial, we randomized 28 new TCu380A IUD users who reported menstrual cycle changes within 4-6 weeks after IUD placement to either naproxen 440 mg or placebo twice daily for 7 days for three consecutive 28-day cycles and one additional 28-day cycle without treatment. Participants completed a daily bleeding and other symptom diary, and monthly questionnaires. Results: Although not statistically significant, participants in the naproxen arm reported more mean number of spotting-only days during the three treatment cycles compared those in the placebo group (13.5 days (SE 5.1) vs.7.5 days (SE 1.7), respectively). Otherwise, the mean number of bleeding-only days during treatment and post-treatment and spotting-only post-treatment were similar between the groups. During each treatment cycle, fewer participants in the treatment group reported heavy bleeding compared to placebo group (30.7% fewer in cycle 2; 5.4% fewer in cycle 3). More women in the treatment group, however, reported prolonged menstrual bleeding of greater than 7 days for each cycle, although the percentage reporting prolonged bleeding decreased each consecutive treatment and post-treatment cycle (+27.5%, +19.8%, +9.1%, +4.5%, cycles 1-4 respectively). Other symptoms experienced by new TCu380A users did not differ between the study arms.Conclusions: Treatment with naproxen did not significantly reduce the number of bleeding or spotting days among new TCu380A users. Although not statistically different, proportionally fewer participants in the naproxen group reported moderate-heavy or heavy periods, but more reported prolonged menstrual bleeding compared to placebo. Participants tolerated oral naproxen use well.Trial registration: ClinicalTrials.gov: NCT02519231. Registered on August 10 2015.

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Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Infection Control and Hospital Epidemiology ◽

10.1086/519929 ◽

2007 ◽

Vol 28 (9) ◽

pp. 1036-1043 ◽

Cited By ~ 88

Author(s):

C. Wendt ◽

S. Schinke ◽

M. Württemberger ◽

K. Oberdorfer ◽

O. Bock-Hensley ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Solution Treatment ◽

University Hospital ◽

Whole Body ◽

Double Blind ◽

Antiseptic Solution ◽

Double Blind Clinical Trial ◽

Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

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Evaluation of the efficacy of an appeasing pheromone diffuser product vs placebo for management of feline aggression in multi-cat households: a pilot study

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x18774437 ◽

2018 ◽

Vol 21 (4) ◽

pp. 293-305 ◽

Cited By ~ 8

Author(s):

Theresa L DePorter ◽

David L Bledsoe ◽

Alexandra Beck ◽

Elodie Ollivier

Keyword(s):

Treatment Group ◽

Positive Reinforcement ◽

Pilot Trial ◽

Time Factor ◽

Educational Training ◽

Double Blind ◽

Aggression Score ◽

Significant Difference ◽

Full Analysis ◽

Promising Treatment

Objectives Aggression and social tension among housemate cats is common and puts cats at risk of injury or relinquishment. The aim of this study was to evaluate the effectiveness of a new pheromone product in reducing aggression between housemate cats. Methods A new pheromone product (Feliway Friends) containing a proprietary cat-appeasing pheromone was evaluated for efficacy in reducing aggression between housemate cats via a randomized, double-blind, placebo-controlled pilot trial of 45 multi-cat households (pheromone [n = 20], placebo [n = 25]) reporting aggression for at least 2 weeks. Each household had 2–5 cats. Participants attended an educational training meeting on day (D) –7 and the veterinary behaviorist described behaviors to be monitored for 7 weeks using the Oakland Feline Social Interaction Scale (OFSIS), which assessed the frequency and intensity of 12 representative aggressive interactions. Participants were also provided with instructions for handling aggressive events, including classical conditioning, redirection by positive reinforcement and not punishing or startling the cat for aggressive displays. Punishment techniques were strongly discouraged. Plug-in diffusers with the pheromone product or placebo were utilized from D0–D28. Participants completed a daily diary of aggressive events and weekly OFSIS assessments through to D42. Results Evolution of the OFSIS–Aggression score according to treatment group in the full analysis set population revealed a significant effect on time and treatment group. The OFSIS–Aggression score decreased over time from D0–D28 in both groups (time factor P = 0.0001) with a significant difference in favor of the verum P = 0.06); similar results were found considering the D0–D42 period (time factor P = 0.0001 [D0] and P = 0.04 [D42]). Conclusions and relevance The OFSIS provided a quantifiable measure of the frequency and intensity of 12 intercat interactions reflecting conflict between cats. The cat-appeasing pheromone is a promising treatment for the management of aggression between housemate cats in multi-cat households.

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The efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helleborus niger D6, Opium D30) in management of excessive daytime sleepiness

10.51415/10321/3050 ◽

2018 ◽

Author(s):

◽

Nondumiso Shabangu

Keyword(s):

Placebo Group ◽

Treatment Group ◽

Excessive Daytime Sleepiness ◽

Daytime Sleepiness ◽

Epworth Sleepiness Scale ◽

Statistical Significance ◽

Controlled Study ◽

Exact Tests ◽

Double Blind ◽

Stanford Sleepiness Scale

Background : Excessive daytime sleepiness (EDS) is the inclination or compulsion to fall asleep whilst intending to stay awake; it is believed to negatively affect occupational and social functioning and may be a predisposition towards accidents (Hayley et al. 2014), low productivity and interpersonal problems (Fong et al. 2005). Excessive daytime sleepiness is one of the most common sleep-related symptoms and it affects an estimated 20% of the population (Pagel .2009). The causes of EDS are numerous and include intrinsic sleep disorders (e.g. narcolepsy, obstructive apnoea/ hypopnea syndrome, idiopathic hypersomnia), and extrinsic disorders (Banerjee et al. 2004). Sleep deprivation is probably the most common cause of excessive daytime sleepiness. This clinic trial intended to evaluate the effectiveness of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) in the management of EDS in terms of the Epworth Sleepiness Scale (Johns, 1991) and Stanford Sleepiness Scale (Hoddes et al. 1973). And this randomised, double-blind placebo controlled study also aimed to provide a safe and effective alternative therapy for EDS. Aim of the study : The objective of this study was to determine the efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) and placebo in the management of EDS in terms of the Epworth Sleepiness Scale (ESS) and the Stanford Sleepiness Scale (SSS). Materials and Methodology : A sample group of 35 participants was selected voluntarily to conduct the study on basis of the inclusion and exclusion criteria. The participants were than randomly divided into two groups; a treatment group consisting of 23 participants and a placebo group consisting of 12 participants. Each participant had to attend three consultations in total with the researcher over a period of four weeks at the Durban University of Technology (DUT) Homoeopathic Day Clinic. At the first consultation a comprehensive case history (appendix F) was taken and physical examination (appendix E) was performed by the researcher but no medication was handed at that point. At each consultation the participants with the help of the researcher completed the Epworth Sleepiness Scale (ESS), and the seven days’ baseline Stanford Sleepiness Scale (SSS) was handed to the participants at the first and second consultation which the participants completed without the help of the researcher throughout the trial till their last consultation. Results : Results from the two measuring tools were statistically analysed with SPSS version 24.0. the participant’s level of sleepiness improved in both the treatment group and the placebo group. Intra-group analyses of ESS means revealed that both groups improved significantly over time, intergroup ANOVA analysis however revealed no significant differences between the groups. Section analyses however using the Fisher’s Exact Tests did reveal statistically significant differences within certain variables at some points of the study. Intra-group analyses of SSS data revealed no statistically significant change in SSS scores over the three weeks in both the Homoeopathic Complex and the Placebo Groups, as well as the Inter-group Fischer’s Exact tests revealed no statistically significant differences between the groups. Conclusion : Barring a few exceptions described in Chapter 4 & 5 it can be concluded from the results of the study that statistically the Homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) was not superior to placebo in the treatment of EDS. The data shows that both the Homoeopathic Complex and the placebo interventions had a positive effect on EDS and were effective in improving the level of excessive daytime Sleepiness. Irrespective of the general lack of statistical significance between groups a closer analysis of the intragroup and inter-group data does reveal a trend suggesting clinical significance in support of the effectiveness of the homoeopathic complex in the treatment of EDS however this needs to be further explored and confirmed in subsequent studies.

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Effectiveness of intrathecal ziconotide in malignant pain: A combined analysis of two controlled trials

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.8552 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 8552-8552

Author(s):

A. W. Burton ◽

B. Lemus ◽

R. Fletcher ◽

S. Chandler ◽

T. Marmon

Keyword(s):

Placebo Group ◽

Calcium Influx ◽

Pilot Trial ◽

Controlled Trials ◽

Dosing Regimen ◽

Double Blind ◽

Percent Improvement ◽

Severe Chronic Pain ◽

The Mean ◽

Intent To Treat

8552 Background: Ziconotide is a nonopioid, N-type calcium channel blocker that inhibits neuronal calcium influx, thereby reducing neurotransmitter release at primary pain afferents. Clinical trials have shown ziconotide is useful in managing severe chronic pain, including nociceptive and neuropathic pain of malignant etiology. We reviewed the effectiveness of ziconotide using the Visual Analog Scale of Pain Intensity (VASPI: 100 mm=worst possible pain, 0 mm=no pain). Methods: Cancer patients from two double-blind, placebo-controlled trials (Studies 95–001 and 301) were analyzed. Study 95–001 used a fast titration scheme over 5 to 6 days, enrolling only patients with malignant pain due to cancer or AIDS. In Study 95–001, the initial dosing regimen was based on a pilot trial and was later modified due to the frequency of adverse events (AEs). The final slower titration, lower dosing regimen resulted in a reduced AE rate. Only patients from the final dosing regimen of Study 95–001 were included in this analysis. Study 301 used a slower titration scheme over 21 days, enrolling patients with malignant or nonmalignant pain. A two-sided, two-sample t-test was used to evaluate the null hypothesis that the mean percent change in VASPI score from baseline to end of titration for the ziconotide group was not significantly different from that of the placebo group (intent-to-treat population). Results: A total of 67 patients with malignant pain were treated in the trials; 51 (35 ziconotide, 16 placebo) had both baseline and end of titration VASPI scores. The ziconotide and placebo groups had similar mean baseline VASPI scores (75.5 and 75.8 mm, respectively). The mean percent improvement in VASPI score was 36.5% in the ziconotide group and 8.6% in the placebo group (p=0.0230). Conclusions: These results indicated that ziconotide was effective in relieving malignant pain. [Table: see text]

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Effect of selenium on markers of risk of pre-eclampsia in UK pregnant women: a randomised, controlled pilot trial

British Journal Of Nutrition ◽

10.1017/s0007114514000531 ◽

2014 ◽

Vol 112 (1) ◽

pp. 99-111 ◽

Cited By ~ 61

Author(s):

Margaret P. Rayman ◽

Elizabeth Searle ◽

Lynne Kelly ◽

Sigurd Johnsen ◽

Katherine Bodman-Smith ◽

...

Keyword(s):

Placebo Group ◽

Pregnant Women ◽

Whole Blood ◽

Pilot Trial ◽

Growth Factor Receptor ◽

Treated Group ◽

Angiogenic Factor ◽

Secondary Outcome ◽

Double Blind ◽

Se Status

Pre-eclampsia is a serious hypertensive condition of pregnancy associated with high maternal and fetal morbidity and mortality. Se intake or status has been linked to the occurrence of pre-eclampsia by our own work and that of others. We hypothesised that a small increase in the Se intake of UK pregnant women of inadequate Se status would protect against the risk of pre-eclampsia, as assessed by biomarkers of pre-eclampsia. In a double-blind, placebo-controlled, pilot trial, we randomised 230 primiparous pregnant women to Se (60 μg/d, as Se-enriched yeast) or placebo treatment from 12 to 14 weeks of gestation until delivery. Whole-blood Se concentration was measured at baseline and 35 weeks, and plasma selenoprotein P (SEPP1) concentration at 35 weeks. The primary outcome measure of the present study was serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia. Other serum/plasma components related to the risk of pre-eclampsia were also measured. Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group. At 35 weeks, significantly higher concentrations of whole-blood Se and plasma SEPP1 were observed in the Se-treated group than in the placebo group. In line with our hypothesis, the concentration of sFlt-1 was significantly lower at 35 weeks in the Se-treated group than in the placebo group in participants in the lowest quartile of Se status at baseline (P= 0·039). None of the secondary outcome measures was significantly affected by treatment. The present finding that Se supplementation has the potential to reduce the risk of pre-eclampsia in pregnant women of low Se status needs to be validated in an adequately powered trial.

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A clinical trial to establish the effectiveness of homoeopathic treatment in conjunction with rational behaviour therapy in the treatment of dysthymic and adjustment disorder

10.51415/10321/2689 ◽

2003 ◽

Author(s):

◽

Natasha Louw

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Adjustment Disorder ◽

Behaviour Therapy ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Depth Interviews ◽

Quantitative And Qualitative Methods ◽

Rational Behaviour

This was a double blind clinical trial, which included both quantitative and qualitative methods of analyses. A placebo group was compared with a treatment group, in order to establish whether or not homoeopathic treatment of dysthymic and adjustment disorder, in conjunction with rational behaviour therapy, altered patient score ratings in terms of the beck depression and yupi inventories. In depth interviews where conducted with each of the participants and content analysis was performed on each individual file.

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Effectiveness of Traditional Chinese Medicine Compound JieDuTongLuoShengJin Granules Treatment in Primary Sjögren’s Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/1315432 ◽

2017 ◽

Vol 2017 ◽

pp. 1-11 ◽

Cited By ~ 1

Author(s):

Ben Li ◽

Jiaqi Hou ◽

Yue Yang ◽

Xuemei Piao ◽

Yueying Chen ◽

...

Keyword(s):

Placebo Group ◽

Treatment Group ◽

Primary Endpoint ◽

Activity Level ◽

Controlled Clinical Trial ◽

Double Blind ◽

Related Data ◽

Laboratory Variables ◽

Gland Function ◽

Saliva Flow

Objective. To evaluate the clinical therapeutic efficacy and safety of JieDuTongLuoShengJin granules + HCQ in patients with pSS. Methods. 40 patients with low-activity-level pSS and without visceral involvement participated in this study and were randomized to receive either JieDuTongLuoShengJin granules with HCQ or placebo with HCQ. Patients and investigators were blinded to treatment allocation. The primary endpoint was week 12 ESSPRI score, while secondary endpoints included ESSDAI, salivary and lacrimal gland function, and some laboratory variables. Safety-related data were also assessed. Results. Comparing with the placebo group, the treatment group experienced statistically significant improvement in the mean change from baseline for the primary endpoint of ESSPRI score and also in PGA. Moreover, in comparison with baseline values, the treatment group had significantly improved ESSDAI score, unstimulated saliva flow rate, and several laboratory variables. However, upon comparison of the two groups, there were no significant differences for them. The incidence of AEs was 10.0%, one in treatment group and three in placebo group. Conclusion. Treatment with a combination of JieDuTongLuoShengJin granules with HCQ is effective in improving patients’ subjective symptoms and some objective indicators of pSS. These results indicate that JieDuTongLuoShengJin is promising as a safe and effective treatment of pSS.

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Successful Response to Microbiota-Based Drug RBX2660 in Patients with Recurrent Clostridium Difficile Infection is Associated with More Pronounced Alterations in Microbiome Profile

Open Forum Infectious Diseases ◽

10.1093/ofid/ofx163.963 ◽

2017 ◽

Vol 4 (suppl_1) ◽

pp. S387-S387 ◽

Cited By ~ 1

Author(s):

Sahil Khanna ◽

Ken Blount ◽

Courtney Jones ◽

Bill Shannon ◽

Sharina Carter

Keyword(s):

Placebo Group ◽

Clostridium Difficile ◽

Multinomial Distribution ◽

Post Treatment ◽

Intestinal Microbiome ◽

Controlled Study ◽

Sequencing Analysis ◽

Dissimilarity Index ◽

Double Blind ◽

Stool Samples

Abstract Background Recurrent Clostridium difficile infections (rCDI) are associated with decreased diversity and altered intestinal microbiome compared with healthy patients. RBX2660, a standardized microbiota-based drug, is designed to restore microbiome diversity and composition in patients’. The effect of RBX2660 on rCDI patient microbiomes was evaluated by comparing pre- and post-treatment samples from PUNCH CD 2—a randomized, double-blind, placebo-controlled study. Methods rCDIsubjects were randomized to receive blinded treatments of 2 doses of RBX2660 (Group A), 2 doses of placebo (Group B), or 1 dose each of RBX2660 and placebo (Group C), by enema 7 days apart. Subjects submitted stool samples at baseline, day 7, 30, and 60 after treatment. Stool samples from responders to RBX2660 treatment per protocol defined as the absence of CDI for 8 weeks after treatment were compared with non-responders. Relative taxonomic abundances at the class level were determined using 16s rRNA sequencing analysis for 94 stool samples from 45 patients in Groups A and C. Relative abundance data were grouped longitudinally using Bray-Curtis dissimilarity index. Analyses were performed based on the Dirichlet-Multinomial distribution to compare group mean relative taxonomic abundances; Simpson and Shannon diversity indices were compared among groups longitudinally. Results Baseline patient microbiomes were similar across response groups. RBX2660 treatment shifted the relative microbiome densities with taxa-specific increase in Bacteroidia, Clostridia, and decrease in Gamma-proteobacteria abundance. A larger shift from baseline microbiome was seen in responders to RBX2600 compared with non-responders (Figure 1). Microbiome changes in responders were durable to 60 days. RBX2660 treatment increased Shannon and Simpson diversity at 7 days post-treatment in responders but not in non-responders (P < 0.05). Conclusion RBX2660 treatment shifts patient intestinal microbiomes with greater alterations seen in those with a successful clinical outcome. Funded by Rebiotix Inc., Roseville, MN. Disclosures S. Khanna, Rebiotix, Inc.: Scientific Advisor, Consulting fee; K. Blount, Rebiotix, Inc.: Employee, Salary; C. Jones, Rebiotix, Inc.: Employee, Salary; B. Shannon, Rebiotix, Inc.: Research Contractor, Consulting fee; S. Carter, Rebiotix, Inc.: Research Contractor, Consulting fee

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Safety and Efficacy of Tien-Hsien Liquid Practical in Patients with Refractory Metastatic Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IIa Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/803239 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 6

Author(s):

Wen-Hung Kuo ◽

Chien-An Yao ◽

Chih Hui Lin ◽

King-Jen Chang

Keyword(s):

Breast Cancer ◽

Placebo Group ◽

Metastatic Breast Cancer ◽

Adverse Events ◽

Pilot Trial ◽

Metastatic Breast ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo ◽

Parallel Group

To evaluate the safety and efficacy of Tien-Hsien Liquid Practical (THL-P), a Chinese herbal mixture, in patients with refractory metastatic breast cancer, we performed a randomized, double-blind, placebo-controlled, parallel-group, phase IIa pilot trial. Patients were randomly assigned to either receive THL-P or matching placebo and followed up every 4 weeks for 24 weeks. The primary endpoint was changes in the global health status/quality of life (GHS/QOL) scale. The secondary endpoints were changes in functional and symptom scales, immunomodulating effects, and adverse events. Sixty-three patients were enrolled between June 2009 and June 2011. The intent-to-treat population included 28 patients in the THL-P group and 11 patients in the placebo group. Compared to the placebo group, the THL-P group had significant improvement from baseline to last visit in GHS/QOL (41.7 versus −33.3;P<0.05), CD3, CD4/CD8, CD19, CD16+56 positive cells (P<0.05), and higher levels of physical, role, emotional, and cognitive functioning, as well as decreased fatigue and systemic side effects. Treatment-related adverse events were mild constipation and localized itching, and no serious adverse events were reported. THL-P appears to be a safe alternative adjuvant treatment for patients with refractory metastatic breast cancer, as it effectively improves QOL and palliates cancer-related symptoms.

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The effect of blue and pink lotus flower extract on acne vulgaris: A randomized double-blind clinical trial

10.14293/s2199-1006.1.sor-.ppmhscs.v1 ◽

2021 ◽

Author(s):

Anna Gordon

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Side Effect ◽

Acne Vulgaris ◽

Treated Group ◽

Small Sample ◽

Double Blind ◽

Flower Extract ◽

Lotus Flower

Background: Acne vulgaris is one of the leading ubiquitous diseases around the world. It is a multifactorial disease which does not threaten life but has serious psychological effects on patients. Patients with moderate to severe acne have been suggested to have poor body image, poor self-esteem, and social isolation and activity constraints. Increased levels of anxiety, anger, depression and frustration are also observed in patients with acne as part of the emotional impact. Research gap: More research onanti-acne treatmentsis necessary for two reasons. First, the prevalence of acne incidence is high and the effect on the quality of life is profound. Second, there is, according to the numerous studies, a lack of ant-acne treatments that have less side effect. The use ofmedicinal plants and particularly blue and pink lotus flower extract, with its autoinflammatory effect, could be promising. The blue and pink lotus flower extract is suggested to reduces the activity of sebum overproduction and helps to balance sebum secretion. Objective:The objective of this study was to examine the medical efficacy ofblue and pink lotus flower extract in acne vulgaris. Method:In a randomized double-blind controlled clinical trial, 42 patients (21 patients in treatment and 21 in placebo group) were randomly received Nymphaea Caerulea Flower Extract, Nelumbo Nucifera Flower and placebo extract, twice daily for 1 month. We recorded he Investigator's Global Assessment (IGA) grading score for each participant. In addition, we evaluated the Acne disability index (ADI) utilizing a standard questionnaire filled out by the participants at the beginning and at the end of the study. Results:The results indicated a 76% mean reduction in the IGA score on the treated group. The mean reduction in the vehicle-treated group, on the other hand, was 4.2%. We also found that the number of comedones, papules, and pustules significantly reduced in the treatment group after 30 days. Additionally, the Acne disability index (ADI) score decreased by 65.01 percent in treatment group, and only 5.6 percent in the placebo group. The current study could not discover any significant side effect in both groups. Conclusion:The blue and pink lotus flower extract had significant effects on improving the symptoms of acnevulgaris. The results of this study, because of the small sample size, should however be interpreted with caution. The future study on the medical efficacy of the mentioned extract should examine with larger samples.

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