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In traditional Persian medicine (TPM), people often use herbal infusions as a dosage form to treat diseases related to hyperglycemia, known as 'dam-kardeh'. Traditionally, herbal preparations of Eryngium bungei Boiss. (E. b), Tragopogon buphthalmoides (DC.) Boiss. (T. b), Salvia hydrangea DC. ex Benth. (S. h), and Juniperus polycarpos K. Koch. (J. p) are used to manage diabetes in Iran. However, there is no evidence of their effectiveness in controlling glucose levels and their mechanisms remain unclear. Aim of the study: This study aimed to investigate whether traditional doses of plant infusions can have hypoglycemic and/or anti-hyperglycemic effects during fasting and/or postprandial states and establish the basis for future research on their potential mechanisms of action. The effects of traditional doses of herbal extracts on blood glucose levels in STZ-NA-induced hyperglycemic rats were investigated in 2-h acute tests during fasting and postprandial states (with a glucose load). In addition, the potential inhibitory effect in vitro of enzymes involved in relevant pathways, such as gluconeogenesis (fructose-1,6-bisphosphatase, FBPase and glucose-6-phosphatase, G6Pase), carbohydrate breakdown (intestinal α-glucosidases), and insulin sensitivity (protein tyrosine phosphatase 1B, PTP-1B) was evaluated. Acute toxicity tests were carried out and HPLC-SQ-TOF was used to analyze the chemical profiles of the plant extracts. In the fasting state, T. b, S. h , and E. b were as effective as glibenclamide in lowering blood glucose levels in hyperglycemic rats. Moreover, all three suppressed G6Pase and FBPase enzymatic activity by 90–97% and 80–91%, respectively. On the other hand, significant postprandial hypoglycemic efficacy was observed for E. b , S. h , and T. b. Based on the AUC values, T. b caused a reduction comparable to the therapeutic efficacy of repaglinide. When investigating the possible mechanisms of action involved in this activity, E. b , S. h , and T. b showed significant inhibition of PTP-1B in vitro (>70%). Finally, all plant extracts showed no signs of acute toxicity. Several compounds that may contribute to biological activities were identified, including phenolic acids and flavonoid glycosides. The present study supports the traditional use of T. b , E. b and S. h for the control of diabetes in the fasting and postprandial state. Moreover, these plants were found to be rich in bioactive compounds with hypoglycemic and antihyperglycemic activities. On the other hand, J. p , showed a modest effect only in the fasting state and after 90 min. Further studies are needed to expand these results by analyzing the chemical composition and using complementary experimental models. [Display omitted] • Eryngium bungei , Tragopogon buphthalmoides , and Salvia hydrangea regulated blood glucose levels in hyperglycemic rats. • All extracts showed no signs of acute toxicity. • The extracts suppressed the enzymatic activity of G6Pase, FBPase, and PTP-1B in vitro as possible mechanisms of action. • Phenolic acid and flavonoid glycosides were identified by HPLC-SQ-TOF as the major compounds in three extracts. [ABSTRACT FROM AUTHOR]

Amla (Phyllanthus emblica) fruit has been emphasized as a hair tonic in Traditional Persian Medicine (TPM) and recommended for hair loss orally and topically. This study aimed to investigate the effect of an oral product containing Amla fruit on Female Androgenetic Alopecia (FAGA). This study was a triple-blind, randomized, controlled clinical trial. Sixty women with FAGA were randomly assigned into two groups of thirty. The intervention group received ten cc Amla syrup thrice a day for 12 weeks. The second group received a placebo with the same dose and duration. Hair growth parameters were analyzed using TrichoScan before and after 12 weeks of intervention. Physician and patient satisfaction were assessed using the CGI-I and PGI-I questionnaires, respectively. Twenty-seven participants in the intervention group and 25 in the placebo group completed the trial. Based on our findings, the anagen-to-telogen ratio increased significantly in the intervention group compared with the group who received placebo (F = 10.4, P = 0.002). Physician and patient satisfaction increased in the amla group compared with placebo at 12th weeks of intervention (P<0.001), (P<0.001). The formula had no remarkable side effects. Only one case of mild constipation was reported in one of the participants after one month of consuming Amla syrup. The results of this study demonstrated that Amla syrup could help treat androgenic hair loss in women and increase the anagen phase. Further studies are needed to evaluate this potential treatment for FAGA. [Display omitted] [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [Display omitted] • Viola odorata is recommended in Persian medicine for respiratory infection symptoms. • This study showed that Viola odorata L. is effective in the treatment of COVID-19. • The drug could relieve cough, myalgia, headache, and diarrhea in SARS-CoV-2 patients. • Violet syrup had no side effects in COVID patients. • It seems the drug subsides lung inflammation and reduces the disease progression. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance Anise is a well-recognized plant in Traditional Persian Medicine (TPM) sources. Anise oil has been suggested for the treatment of bowel disorders in Persian medical textbooks. Based on TPM scholars, this ingredient has a favorable effect on gastrointestinal diseases. We did this trial to determine the efficacy and safety of enteric coated capsules of anise oil for clinical symptoms of irritable bowel syndrome (IBS). Methods and materials This three-armed double-blind clinical trial was carried out from August 2014 to February 2015. 120 patients were divided into three groups by block randomization: AnisEncap, placebo and Colpermin ® . Patients in each group received 3 similar capsules per day for 4 weeks. The primary outcome was measured as a visual analogue scale (VAS) score, and the secondary outcome was assessed with an IBS-quality of life questionnaire. Chi-squared tests were used for categorical variables and t -tests to compare continuous variables. Results There were no significant differences in demographic characteristics among the three groups. According to intention-to-treat sample analysis, 75% of patients in the treatment group, 35% in the placebo group and 52.5% in active control group were free from IBS symptoms ( P <0.001). The effectiveness of AnisEncap in improving IBS symptoms (abdominal discomfort or pain, bloating, diarrhea, constipation severity, difficulty in defecation, gastroesophageal reflux, headache, tiredness, overall satisfaction and quality of life) was significantly greater than placebo or Colpermin ® after the 4-week treatment period and the 2-week follow-up period ( P <0.0001). The number needed to treat for enteric coated capsules of anise oil was 4, which indicated significantly superior efficacy compared to the other two groups ( P <0.001). Conclusion The effectiveness of AnisEncap was superior to that of placebo or Colpermin ® in patients with IBS. Further studies are suggested to find the main mechanism of action of anise oil in this regard. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance Sambucus ebulus L. (S. ebulus) has had long-standing application in Traditional Persian Medicine for joint pain and for a variety of bone and joint disorders. According to traditional use of S. ebulus and its relevant pharmacologic properties, this study was designed to evaluate the efficacy and short-term safety of topical use of S. ebulus in patients with knee osteoarthritis (OA). Methods and materials Seventy nine patients with knee OA were randomly enrolled in 2 parallel arms of a pilot randomized, double-blind, active-controlled clinical trial. The patients were treated by topical S. ebulus gel or 1% diclofenac gel, three times a day, as much as a fingertip unit for 4 weeks. Patients were assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention, in terms of scores of visual analogue scale (VAS) for self-grading of their knee joint pain, and according to 3 different domains of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Any observed adverse effects were also scrutinized. Results The mean values of WOMAC pain score, total WOMAC score and VAS score for pain of the S. ebulus group were significantly lower compared with the diclofenac group (P=0.004, P=0.04, and P<0.001, respectively). In addition, no serious adverse effect was reported. Conclusion This pilot study showed that topical treatment with S. ebulus gel can be recommended for alleviating symptoms of patients with knee OA. However, longer trials involving larger samples size, are needed for achieving a comprehensive understanding about the efficacy and safety of S. ebulus in knee OA. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance A honey based formulation from Nigella sativa L. (N. sativa) has been used in Traditional Persian Medicine for upper gastrointestinal symptoms. Considering the traditional use of this formulation and its ingredients known pharmacologic effects, this study aimed to evaluate the efficacy and safety of N. sativa seed oil mixed with honey in treatment of patients with functional dyspepsia. Methods and materials Seventy patients diagnosed with functional dyspepsia according to ROME III criteria and confirmed by upper gastrointestinal endoscopy were selected to receive a traditional honey based formulation of N. sativa (5 ml N. sativa oil orally daily) or placebo for 8 weeks in a double-blind randomized placebo-controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 8 weeks of the intervention in terms of the Hong Kong index of dyspepsia severity, presence of Helicobacter pylori infection based on urease test, scores in different domains of short form (SF-36) health survey, and any observed adverse events. Results The mean scores of Hong Kong index of dyspepsia severity sores and the rate of H. pylori infection were significantly lower in the N. sativa group comparing the placebo group after the intervention ( P <0.001). No serious adverse event was reported. Conclusion This study showed that adjuvant supplementation of honey based formulation of N. sativa can cause significant symptomatic improvement of patients with functional dyspepsia whom received the standard anti-secretory therapy. The results should be investigated further in studies with longer duration and larger sample size. [ABSTRACT FROM AUTHOR]

Carthamus tinctorius L. (Safflower) has been widely recommended to treat metabolic disorders in traditional herbal medicine in Persia, China, Korea, Japan, and other East-Asian countries. The anti-hypercholesterolemic and antioxidant effects of this plant have been well documented, but its protective effects against Metabolic Syndrome (MetS) have not been fully illustrated. The present study aimed to evaluate the effects of safflower oil on MetS risk factors. In this randomized, double-blind, placebo-controlled clinical trial, 67 patients with MetS were administered either divided 8 g safflower oil or placebo daily for 12 weeks. All patients were advised to follow their previous diets and physical activities. Safflower oil resulted in a significant reduction in waist circumference (-2.42 ± 3.24 vs. 0.97 ± 2.53, p<0.001), systolic blood pressure (-8.80 ± 9.77 vs. -2.26 ± 8.56, p = 0.021), diastolic blood pressure (-3.53 ± 7.52 vs. -0.70 ± 6.21, p = 0.041), fasting blood sugar (-5.03 ± 10.62 vs. 2.94 ± 7.57, p = 0.003), and insulin resistance (-0.59 ± 1.43 vs. 0.50 ± 1, p = 0.012), but an increase in adiponectin level (0.38 ± 0.99 vs. -0.09 ± 0.81, p = 0.042) in the treatment group in comparison to the placebo group. The results revealed a direct relationship between leptin level and Body Mass Index (BMI) in both groups (p<0.001). In addition, increase in BMI resulted in a non-significant decrease in adiponectin level in both groups. Moreover, no significant difference was observed between the two groups regarding lipid profiles, leptin serum level, serum creatinine concentration, and other outcomes. Safflower oil without lifestyle modification improved abdominal obesity, blood pressure, and insulin resistance in patients with MetS. [Display omitted] • Safflower seed oil without lifestyle modification reduced waist circumference, waist to hip ratio, systolic and diastolic blood pressure. • Insulin resistance and fasting blood glucose decreased significantly by consuming safflower seed oil for three months. • Safflower seed oil improved serum adiponectin level in patients living with metabolic syndrome. [ABSTRACT FROM AUTHOR]

Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out. In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil). Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin. Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level. It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients. Image 1 [ABSTRACT FROM AUTHOR]

Lime Salve (L.S) has been well documented from the 9th to the 19th century AD by traditional Iranian medicine (TIM) as an effective remedy for burn healing. The present study was undertaken to evaluate the healing effect and related underlying mechanisms of Lime Salve in a model of deep second-degree thermal burn in male Wistar rats. L.S was made up of a combination of refined calcium hydroxide powder, beeswax and sesame oil and its quality control was assessed. A deep second-degree burn was created by a hot plate in 48 male Wistar rats. Afterwards, they were randomly divided into four groups including normal saline (C group), L.S (T group), basement of formulation composed of beeswax and sesame oil (B group) and silver sulfadiazine (S group). On days 5, 10, 17 and 24, the wounds were digitally photographed by a camera and after sacrifice of the rats, skin samples were obtained for performing qRT-PCR, immunohistochemistry staining and histological examination. L.S prominently augmented the wound closure rate, neovascularization on day 10 and collagen formation on days 17 and 24 in comparison with the C group. Furthermore, the Salve-exposed specimens showed a significant higher epithelialization during the experiment with a peak on day 24. qRT-PCR also showed that on day 10, VEGF and TGF-β1 genes were significantly higher in the T group as compared with the C group. Also, MMP-9 and MMP-2 genes had a significant peak of expression on day 17 and rapid reduction of expression on day 24. Expression levels of IL-6 and TNF-α genes peaked on day 10 in the T group, followed by a progressive reduction until the end of the examination. L.S could effectively accelerate the healing process of deep second-degree burn wounds and therefore, it may be recommended as a promising topical medication for treating burn wounds in the future clinical trials. Image 1 [ABSTRACT FROM AUTHOR]