scholarly journals The effect of Melissa officinalis syrup on patients with mild to moderate psoriasis: a randomized, double-blind placebo-controlled clinical trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis. Result Among 100 patients, 95 participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P < 0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P = 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration: The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434; registration number: IRCT20191104045326N1).

scholarly journals The Effect of Melissa Officinalis Syrup on Patients With Mild to Moderate Psoriasis: a Randomized, Double-blind Placebo-controlled Clinical Trial

2021 ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective: Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis.Result: Among 100 patients, ninety-five participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P<0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P= 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434 ; registration number: IRCT20191104045326N1).

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.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals Eremostachys laciniata as effective as rectal diclofenac suppository in cesarean section pain relief: A triple-blind controlled clinical trial

2020 ◽  
Vol 12 (1) ◽  
pp. 26-34
Author(s):  
Shabnam Mohammad Pour ◽  
Sevil Hakimi ◽  
Abbas Delazar ◽  
Yousef Javad Zadeh ◽  
Fatemeh Mallah
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Intervention Group ◽  
Massive Hemorrhage ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Total Extract ◽  
Significant Difference ◽  
Healing Score ◽  
Distress Scale

Background: Pain and distress are two common complications of cesarean section. Among complementary therapies, Eremostachys was introduced as a pain mitigator. This study aimed at investigating the effect of Eremostachys laciniata on cesarean section pain and distress. Materials and methods: This randomized clinical trial was conducted on 86 women who gave childbirth by cesarean section. The control group received 50 mg rectal diclofenac suppository every 8 h for 3 days, and the intervention group received 35 mg E. laciniata total extract suppository every 8 h up to three doses. Pain was measured with the Visual Analogue Scale at 8, 16, and 24 h after cesarean section. The Symptom Distress Scale was completed at 8 and 24 h after cesarean section. The Redness, Edema, Ecchymosis, Discharge, Approximation scale was completed 5 days after cesarean section. Findings: Pain score at 8, 16, and 24 h after surgery (15 min after intervention) was not significantly different between the intervention and control groups. The distress score 24 h after cesarean section showed a significant difference in favor of the control group according to Friedman’s test. There was a significant difference between the two groups in wound healing score, which indicated better efficacy of rectal diclofenac suppository than E. laciniata suppository. We assessed nausea, vomiting, headache, massive hemorrhage, and any type of anaphylactic reaction. No side events were observed in two groups. Conclusion: Rectal E. laciniata suppository could be introduced as a low-complication, appropriate, and effective medication in controlling pain and distress after cesarean section; more studies should be conducted on this matter.

The Efficacy of The Administration of BifidobacteriumLactis For Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Mohammad Ali Pourmirzaiee ◽  
Fatemeh Famouri ◽  
Akram Kahid ◽  
Silva Hovsepian ◽  
Roya Kelishadi
Keyword(s):  
Clinical Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Infantile Colic ◽  
Double Blind ◽  
Bifidobacterium Lactis ◽  
Bifidobacterium Animalis ◽  
Significant Difference ◽  
Study Offer

Abstract The aim of this trial was to evaluate the efficacy of Bifidobacterium Lactis administration on infantile colic (IC). In this double blind randomized, placebo‐controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age more than 37 weeks and birth weight more than 2500 gram were included. The selected infants randomly allocated in the two groups of BBcare group, treated with Bifidobacterium animalis subsp. lactis and the control group treated with placebo, 5 drops per day, for 6 weeks. The mean of crying, vomiting episodes and defecation number at baseline and during follow ups (40 and 60 days after intervention) were compared between the two studied groups. In this study from initially enrolled neonates, 40 and 38 neonates in BB-12 and placebo groups completed the study. In BB-12 group number of defecation, crying and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration(P<0.05).In the placebo group there was significant decrease for crying and vomiting episodes between baseline and 60 days after intervention(P<0.05). Between group analyses indicated that there was significant difference between groups regarding mean of crying and vomiting episodes and number of defecation ,60 days after intervention(P<0.05).Conclusion: Findings of our study offer compelling signals for the effectiveness of Bifidobacterium animalis subsp. lactis BB‐12 in the management of some intestinal problems. These findings could be supportive evidences for the important role of gut microbiota as goal of intervention to improvement in bowel movement and comfortable defecation in IC.

scholarly journals Effects of Ferula on Polycystic Ovary Syndrome

2020 ◽  
Author(s):  
Ghavi Fatemeh ◽  
Somayeh Abdolahian ◽  
Shakeri Fatemeh
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary ◽  
Endometrial Thickness ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Ovarian Follicles ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Ovarian Syndrome

Abstract BackgroundPolycystic ovarian syndrome is the most common endocrine disorder in reproductive aged women. As a result of side effect of pharmaceutical medications women are interested in using alternative medicines to treat. To determine the comparative effects of Ferula assa-foetida on androgenic hormone levels and ovarian features in patient with polycystic ovarian syndrome (PCOS). MethodsIn this triple-blinded controlled clinical trial, 34 student participants were randomly divided in two groups. Intervention group received 100 mg of oleo-gum resin of Ferula assa- foetida, control group received oral paraffin (Placebo) twice daily for 3 months. The efficacy of this herbal medicines was measured after the 3-month intervention. Hormonal assay for evaluating Testosterone, DEHAS, Prolactin, TSH, FSH, LH levels and also trans abdominal ultrasound for evaluating ovarian volumes, number of follicles of both ovaries, and endometrial thickness. Were measured before and after the study. ResultsIn this study, significant changes in DEHAS and TSH level were observed (p value<0.03). The greatest reduction in the number of ovarian follicles was reported in the Ferula group (p value <0.00). ConclusionUse of Ferula assa-foetida can be effected in decrease of DHEAS, TSH levels, and ovarian follicles number in young girls with PCOS.Trial registrationthe Iranian Randomized Clinical Trial (IRCT2016040427207N1).url: https://www.irct.ir/trial/22343

Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial

2017 ◽  
Vol 96 (1) ◽  
pp. E7-E21 ◽  
Author(s):  
Mehrzad Bahtouee ◽  
Gholamhosein Monavarsadegh ◽  
Mohammadjavad Ahmadipour ◽  
Mazyar Motieilangroodi ◽  
Niloofar Motamed ◽  
...  
Keyword(s):  
Clavulanic Acid ◽  
Normal Saline ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Common Disease ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Amoxicillin Clavulanic Acid

Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

scholarly journals Effectiveness of Olea Herbal Ointment on Episiotomy Wound Healing Among Primiparous Women: A Randomized Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Shokoufeh Torkashvand ◽  
Fatemeh Jafarzadeh-Kenarsari ◽  
Yalda Donyaei-Mobarrez ◽  
Bahare Gholami Chaboki
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Intervention Group ◽  
Repeated Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Exact Test ◽  
Significant Difference ◽  
Perineal Region ◽  
Primiparous Women

Background: Episiotomy is a surgical incision in the perineal region to increase the vaginal diameter during delivery. Since the perineal region is not well visible to the mothers and there is a possibility of infection for the episiotomy wound by vaginal and rectal bacteria, such a cut is associated with infection and delay in wound healing. Objectives: This study aimed to detect the effect of Olea ointment on episiotomy wound healing among primiparous women. Methods: This randomized controlled clinical trial included 73 women referring to the Al-Zahra educational, research, and remedial center in Rasht, Iran, during 2017 - 18. Women were randomly assigned into two groups: Intervention group (n = 39) and control group (n = 34). Episiotomy wound healing was assessed using the REEDA scale prior to the intervention, 2 and 24 hours following the first intervention, and 5 and 10 days after delivery. Statistical analysis was performed using Fisher’s exact test, Mann-Whitney U test, independent t-test, repeated-measure test, Friedman test, and chi-square. Results: The mean baseline scores of REEDA was 2.72 ± 0.46 in the Olea ointment group and 2.71 ± 0.46 in the control group; however, there no statistically significant difference between the two groups. On the other hand, the episiotomy healing scores in the Olea ointment group were significantly lower than those of the control group at four intervals in the follow-up assessments: -0.34 (95% CI: -0.56 to -0.12) two hours after intervention, -0.63(95% CI: -0.89 to -0.37) 24 hours after intervention, -0.30 (95% CI: -0.48 to -0.12) on Day 5 postpartum, and -0.29 (95% CI: -0.46 to -0.13) on Day 10 postpartum. Conclusions: The present findings suggested that the Olea ointment facilitated wound healing episiotomy; however, further studies are suggested to support these data.

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