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Topical Nigella sativa L. product: a new candidate for the management of diabetic peripheral neuropathy.
Khodaie, SA, Nikkhah, H, Namiranian, N, Abotorabi, M, Askari, M, Khalilzadeh, SH, Khatibi Aghda, A, Kamalinejad, M
Inflammopharmacology. 2024;(1):551-559
Abstract
BACKGROUND Diabetic neuropathy is one of the most common complications of diabetes. The synthetic drugs available in the market have side effects and limitations for diabetic patients, the vast majority of whom are in the upper age group. In this regard, based on Persian medicinal sources, Nigella sativa (N. sativa) has proved to have beneficial effects on neuropathic pain and neurological disorders. In this study, the effect of N. sativa is investigated topically in patients with diabetic neuropathy. METHODS This study was performed as a double-blind clinical trial on 120 neuropathic patients. The patients were divided into three groups. The first group received a topical N. sativa product as an ointment, the second group was given a topical placebo, and the third received 300 mg gabapentin capsules. The blindness was done in first and second groups. Diabetic neuropathy was assessed before the study using the Michigan Neuropathy Screening Instrument (MNSI). In addition, neuropathy symptoms were evaluated after the trial using the MNSI questionnaire. RESULTS The data were elicited from the patients' answers to a number of questions in the Michigan questionnaire. There were statistically significant differences between the group that received the topical N. sativa product and the other two groups in terms of legs and feet numbness (p value = 0.001), burning pain in feet or legs (p value = 0.001), muscle cramps in feet or legs (p value = 0.001), prickling fleeing in feet or legs (p value = 0.001), hurting of the skin when the bed covers touch it (p value = 0.005), aggravated symptoms at night (p value = 0.001) and hurting feelings in the legs when walking (p value = 0.032). However, the three studied groups were not statistically different in distinguishing hot water from cold water. CONCLUSION According to the results of this study, the topical use of N. sativa, compared to the current drugs, has acceptable improving effects on diabetic neuropathic patients.
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Effect of Sinamaz nasal drop on asymptomatic family members of COVID 19 patients: An open-label randomized controlled trial.
Daneshfard, B, Aghanouri, R, Kazemnejad, A, Fatima Shad, K, Cordato, D, Soubra, W, Bahaeddin, Z, Hosseini, SMJ, Ravanshad, M, Alijaniha, F, et al
Phytotherapy research : PTR. 2024;(4):1727-1730
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Lavender and metformin effectively propagate progesterone levels in patients with polycystic ovary syndrome: A randomized, double-blind clinical trial.
Simaei, SR, Askari, VR, Rostami, M, Kamalinejad, M, Farzaei, MH, Morovati, M, Heydarpour, F, Jafari, Z, Baradaran Rahimi, V
Fitoterapia. 2024;:105720
Abstract
BACKGROUND The present study aimed to evaluate the impacts of lavender and metformin on polycystic ovary syndrome (PCOS) patients. METHODS We performed a randomized, double-blind clinical trial including 68 females aged 18 to 45, fulfilling the Rotterdam criteria for PCOS. The patients were randomized to receive lavender (250 mg twice daily) or metformin (500 mg three times a day) for 90 days. The serum progesterone was measured at baseline and after 90 days, one week before their expected menstruation. Moreover, the length of the menstrual cycle was documented. RESULTS Our results showed that lavender and metformin treatment notably increased the progesterone levels in PCOS patients (increasing from 0.35 (0.66) and 0.8 (0.69) to 2.5 (6.2) and 2.74 (6.27) ng/mL, respectively, P < 0.001). However, we found no significant differences between the increasing effects of both treatments on progesterone levels. In addition, all patients in the lavender or metformin groups had baseline progesterone levels <3 ng/mL, reaching 14 (45.2%) patients >3 ng/mL. Lavender and metformin remarkably attenuated the menstrual cycle length in PCOS patients (decreasing from 56.0 (20.0) and 60 (12.0) to 42.0 (5.0) and 50.0 (14.0) days, respectively, P < 0.001). Furthermore, the decreasing effects of lavender on the menstrual cycle length were greater than the metformin group; however, it was not statistically significant (P = 0.06). CONCLUSION Lavender effectively increased progesterone levels and regulated the menstrual cycles in PCOS patients, similar to metformin. Therefore, lavender may be a promising candidate for the treatment of PCOS.
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The effect of a standardized capsule of Aloe vera gel on the quality of life in patients with systolic heart failure: A randomized double-blind placebo-controlled clinical trial.
Sabbaghzadegan, S, Soltani, MH, Kamalinejad, M, Bahrami, M, Kabir, A, Dadmehr, M
Phytotherapy research : PTR. 2023;(7):2800-2810
Abstract
This trial was designed to evaluate the effect of a standardized capsule of Aloe vera gel (AVG) on the quality of life (QOL) in patients with systolic heart failure (HF). Forty-two patients were randomly divided into two groups to receive either AVG 150 mg or harmonized placebo capsules twice a day for 8 weeks. The patients were evaluated before and after the intervention using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), New York Heart Association (NYHA) functional class, six-minute walk test (6MWT), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI) and STOP-BANG questionnaires. Post-intervention, AVG group indicated a significant reduction in the total score of MLHFQ (p < 0.001). The changes in MLHFQ and NYHA class were statistically significant after taking medication (p < 0.001 and p = 0.004, respectively). The change of 6MWT in the AVG group was more advanced; however, it was not statistically significant (p = 0.353). Moreover, in the AVG group, the severity of insomnia and obstructive sleep apnea decreased (p < 0.001, p = 0.01 respectively) and the sleep quality improved as well (p < 0.001). There were significantly fewer adverse events reported in the AVG group (p = 0.047). Therefore, AVG combined with standard medical therapy could provide more clinical benefits for patients with systolic HF.
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The effects of aqueous and ethanolic extracts of Rheum ribes on insulin-resistance and apolipoproteins in patients with type 2 diabetes mellitus: a randomized controlled trial.
Ghafouri, A, Jafari Karegar, S, Hajiluian, G, Hosseini, S, Shidfar, S, Kamalinejad, M, Hosseini, AF, Heydari, I, Shidfar, F
BMC complementary medicine and therapies. 2023;(1):46
Abstract
BACKGROUND AND AIM Previous studies have shown that Rheum ribes (R. ribes) could be effective in controlling the blood glucose levels. This study was conducted to determine the effects of R. ribes supplementation on glycemic indices and apolipoproteins in patients with type 2 diabetes mellitus (T2DM). METHODS In the present randomized double-blind controlled trial, 60 type 2 diabetic patients aged 30-60 years with a body mass index (BMI) of 20-30 kg/m2 and hemoglobin A1c (HbA1c) of 6-8% were enrolled. Patients were randomly assigned to receive 450 mg of aqueous R. ribes extract (AG), 450 mg of ethanolic R. ribes extract (EG), or placebo (PG) three times daily for 6 weeks. At the baseline and at the end of the study, blood glucose levels, homeostatic model assessment of insulin resistance (HOMA-IR) and the homeostatic model assessment of β-cell dysfunction (HOMA-B), as well as apolipoprotein A-I (ApoA1) and apolipoprotein B (ApoB) were measured. RESULTS There was a significant decrease in the serum levels of insulin in AG and EG groups (P = 0.003 and P = 0.001, respectively), HOMA-IR (P = 0.01 and P = 0.001, respectively), HOMA-B (P = 0.002 and P = 0.001, respectively), ApoB (P = 0.006 and P = 0.03, respectively), ApoB/ApoA1 ratio (P = 0.016 and P = 0.04, respectively). However, a significant increase in ApoA1 (P = 0.08 and P = 0.05, respectively) with no significant changes in blood glucose, at the end of study compared to beginning values, were observed. None of the variables showed a significant change in PG. At the end of the study; while there were significant differences in insulin (P = 0.04), HOMA-IR (P = 0.03), HOMA-B (P = 0.01), ApoB (P = 0.02), and ApoB/ApoA1 ratio (P = 0.03) among the groups but ApoA1 had no significant change. CONCLUSION Consumption of R. ribes intake could have beneficial effects on insulin resistance and apolipoproteins in type 2 diabetic patients. (Registered at en.irct.ir, identification number: IRCT201410142709N31).
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Efficacy and safety of add-on Viola odorata L. in the treatment of COVID-19: A randomized double-blind controlled trial.
Adel Mehraban, MS, Shirzad, M, Mohammad Taghizadeh Kashani, L, Ahmadian-Attari, MM, Safari, AA, Ansari, N, Hatami, H, Kamalinejad, M
Journal of ethnopharmacology. 2023;:116058
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Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Severe Acute Respiratory Syndrome (SARS) due to the novel coronavirus has become the highest priority that threatens human health. This situation demands widespread vaccination and the innovation of new therapeutic methods. Despite drug discoveries, the need for approving new medicaments is felt because of adverse effects and lack of efficacy. Several medicinal plants including Viola odorata L. are recommended in traditional Persian medicine for alleviating respiratory infection symptoms. Recent studies showed anti-inflammatory, antioxidant, anti-asthmatic, antitussive, analgesic, and antibacterial activities of sweet violet. These enhance respiratory functions, reduce pulmonary inflammation, and decline mucous membrane edema. This study aimed to evaluate the efficacy of sweet violet syrup in alleviating the manifestations of COVID-19 infection. MATERIAL AND METHODS A randomized parallel-group double-blind controlled trial was conducted at Al-Zahra general hospital, Isfahan, Iran. A total of 108 outpatients were enrolled in the study. The patients were randomly allocated to intervention and placebo groups, with 54 patients in each group. The allocation was concealed using sealed opaque envelopes. The intervention group received violet syrup and the control group received placebo syrup, an add-on to the conventional treatment. The outcomes were COVID-19 manifestations, such as dyspnea, cough, myalgia, headache, and diarrhea, considered as outcomes of the study and were evaluated twice using a visual analog scale before the intervention and after 7 days, at the end of the study. Patients were followed daily by phone calls to monitor proper drug consumption and possible side effects. RESULTS No significant difference was between groups regarding demographic characteristics and vital signs before and after the treatment. Although all symptoms have improved significantly in both groups, patients who received violet syrup recovered faster and the mean severity scores of cough (P = 0.025), myalgia (P = 0.036), headache (P = 0.037), and diarrhea (P = 0.044) decreased greater in comparison to control group. CONCLUSION This study, the first clinical trial on the effectiveness of Viola odorata on SARS-CoV-2 patients, showed that Viola odorata L. effectively controls prevalent manifestations of COVID-19 including cough, myalgia, headache, and diarrhea. Regarding this survey, the violet syrup can be mentioned as a complementary treatment for viral influenza-like infections in which cough, myalgia, headache, and diarrhea are prominent.
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Effect of topical marshmallow (Althaea officinalis) on atopic dermatitis in children: A pilot double-blind active-controlled clinical trial of an in-silico-analyzed phytomedicine.
Naseri, V, Chavoshzadeh, Z, Mizani, A, Daneshfard, B, Ghaffari, F, Abbas-Mohammadi, M, Gachkar, L, Kamalinejad, M, Jafari Hajati, R, Bahaeddin, Z, et al
Phytotherapy research : PTR. 2021;(3):1389-1398
Abstract
Atopic dermatitis (AD) is a chronic relapsing eczematous skin disease, which primarily affects infants and young children. Due to the side effects of commonly used drugs for its treatment, the development of safer therapeutic strategies is needed. There are many reports on the topical use of marshmallow (Althaea officinalis) for a range of skin diseases in Persian medicine. The main aim of the present investigation was evaluating the efficacy of marshmallow in children with mild-to-moderate atopic dermatitis. Another aim of the study was screening the anti-allergic and anti-inflammatory potential of phytocomponents against target proteins, including TNF-alpha, IL6, and PDEs A, B, and D enzymes with PDB IDs: 2AZ5, 1P9M, 3I8V, 4KP6, and 1Y2K, respectively, along with their respective standard ligands using computational docking analysis. A pilot clinical trial was designed to investigate the safety and efficacy of Althaea officinalis in children with AD. The diagnosis of AD was made according to the criteria of Hanifin and Rajka. Children between 3 months and 12 years old were participated in this trial and randomly allocated into two parallel intervention and control groups. The intervention group used Althaea officinalis 1% ointment while the positive control group used Hydrocortisone 1% ointment twice a day for a week and after that, three times per week for a period of 3 weeks. The severity of AD was measured using the SCORAD score at the end of each assessment visits. A total number of 22 patients completed the study. A significant decrease of the SCORAD score was observed in both groups. At the end of the study, this score change, which indicates the improvement of the patients was significantly higher in the intervention group in comparison to the baseline (p-value = .015) and week 1 (p-value = .018). In the docking analysis of the study, 33 phytochemical compounds were identified, which were docked into the active site of IL6, TNF-alpha, and human PDE4 isoenzymes. Affinity toward the selected enzymes was significantly higher in glycosylated compounds. The results of this pilot study showed that the efficacy of Althaea officinalis 1% ointment in a decrease of disease severity is more than Hydrocortisone 1% in children with AD. However, further studies are needed to confirm this finding. Moreover, the docking analysis revealed that the inhibitory activity of compounds with free hydroxyl groups such as glycosylated compounds was better than others, probably due to the hydrogen bond interaction of hydroxyl groups of the ligands with the enzymes.
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The Effect of a Persian Herbal Medicine Compound on the Lipid Profiles of Patients with Dyslipidemia: A Randomized Double-Blind Placebo-Controlled Clinical Trial.
Niknafs, A, Rezvanfar, M, Kamalinejad, M, Latifi, SA, Almasi-Hashiani, A, Salehi, M
Evidence-based complementary and alternative medicine : eCAM. 2021;:6631963
Abstract
INTRODUCTION It has been well established in the world that lipid disorders promote the development of atherosclerosis and its clinical consequences. This study aimed to assess the impacts of a Persian medicinal (PM) compound on lipid profile. MATERIALS AND METHODS From June 21 to October 21, 2020, a randomized double-blind controlled clinical trial was conducted with 74 dyslipidemic patients, who were randomly divided into two equally populated groups: one prescribed with a Persian medicinal herbal compound (n = 37) and a placebo group (n = 37). A Persian herbal medicine including fenugreek, sumac, and purslane is introduced. Biochemical parameters including 12-hour fasting serum levels of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), and triglyceride (TG) were measured before the initiation and after the completion of study protocol. RESULTS Percent changes of biochemical parameters include the following: intervention group = cholesterol: 35.22, Tg: 45.91, LDL: 24.81, HDL: 2.05, VLDL 8.94 and placebo group = cholesterol: 6.94, Tg: -7.3, LDL: 7.37, HDL: 2.88, VLDL -0.14. The serum levels of total cholesterol (p=0.01) and LDL (p=0.01) significantly decreased and no increase was recorded in HDL (p=0.03) levels over time in the intervention group. Furthermore, between-group analysis showed a statistically significant difference between the intervention and placebo groups in this regard. VLDL (p=0.2) and TG (p=0.2) levels also decreased, however not significantly. CONCLUSION This study showed that a Persian medicinal herbal compound could be safe and beneficial to decrease the levels of serum cholesterol and LDL in dyslipidemic patients. However, larger long-term studies are recommended to clarify this effect.
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Potential protective effects of Aloe vera gel on cardiovascular diseases: A mini-review.
Sabbaghzadegan, S, Golsorkhi, H, Soltani, MH, Kamalinejad, M, Bahrami, M, Kabir, A, Dadmehr, M
Phytotherapy research : PTR. 2021;(11):6101-6113
Abstract
Cardiovascular diseases (CVDs) comprise the most prevalent causes of morbidity and mortality in both men and women worldwide. CVDs are associated with several risk factors such as hyperlipidemia, diabetes mellitus, hypertension, obesity, tobacco smoking and an unhealthy diet. Currently, in addition to the use of related pharmacological treatments in the management of CVDs, the investigation of other suitable healthcare approaches for these disorders such as the identification of herbal medicines has been considered in the scientific communities. Aloe vera (L.) Burm.f. is a perennial medicinal plant. The innermost leaf layer of this plant contains transparent gel, which is used as food. Pre-clinical studies have shown several biological activities of A. vera gel (AVG), including antidiabetic, lipid-lowering, antioxidant, antiinflammatory, hepatoprotective, and immunomodulatory effects. Other pharmacological activities of AVG such as anti-fibrotic, anti-hypertensive, and anti-atherosclerotic effects have been reported. Moreover, several clinical studies have demonstrated the ameliorating effects of AVG on some markers of CVDs risk factors. Thus, this study was conducted to review clinical trials besides in vitro and in vivo studies on the cardiac beneficial effects of AVG. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.
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Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.
Meysami, M, Hashempur, MH, Kamalinejad, M, Emtiazy, M
Endocrine, metabolic & immune disorders drug targets. 2021;(9):1673-1678
Abstract
BACKGROUND Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant, which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown the anti-ulcerogenic and anti-inflammatory activity of this plant. OBJECTIVE We designed a clinical trial to evaluate the efficacy of topical cream of the M. sylvestris extract in the management of children with AD. METHODS Fifty-one children with AD were randomly enrolled in two arms of a randomized, double- blind, controlled clinical trial. They were treated by topical cream of the M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure. RESULTS There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively). CONCLUSION According to the results of this clinical trial, it could be concluded that the topical use of M. sylvestris extract cream was effective in the reduction of AD symptoms in children. TRIAL REGISTRATION This study is registered by the Iranian Registry of Clinical Trials with the code: IRCT20170107031814N2.