Examination of the Topical Effect of the Combination of Plantago ovata and Vinegar on the Improvement of Rural Cutaneous Leishmaniasis Lesions.

Background: The present study aimed at investigating the topical effect of the combination of Plantago ovata and vinegar on the improvement of rural cutaneous leishmaniasis lesions. Materials and Methods: The present randomized double-blind controlled clinical trial was performed on 42 patients with rural skin leishmaniasis. In the case group, in addition to injecting glucantime into the lesion according to the latest national instructions, a combination of P. ovata and vinegar was applied topically twice a day for 8 weeks. In the control group, only glucantime injection into the lesion was performed for 8 weeks according to the latest national guidelines. At the end of the 1st, 2nd, 3rd, 4th, 8th, and 12th weeks after the intervention, the lesion area and improvement were evaluated and recorded. Results: The results of the present study indicated the lesion area in the case group with the mean of 0.35 ± 0.39 cm and 0.18 ± 0.27 cm in the 8th and 12th weeks, respectively was significantly less than that of the control group with the mean of 0.64 ± 0.78 cm and 0.56 ± 0.44, respectively (P < 0.05). Twelve weeks after the intervention, 84.1% of the lesions in the case group and 65.9% of the lesions in the control group were completely improved (P < 0.05). Conclusion: According to the results of the present study, the improvement of leishmaniasis lesion with the topical application of the combination of P. ovata and vinegar was significantly more than that of the control group in the 8th and 12th weeks after the intervention.

Coconut oil rubbing as an easy and safe way to improve symptoms in primary nocturnal enuresis: A randomized double-blinded placebo-controlled clinical trial.

Objective: Enuresis is a common pediatric problem for which, no unique therapy has been suggested. The conventional therapy is effective, but fails in some cases. So, many parents try complementary medicine. Therefore, this study attempted to find if rubbing coconut oil is effective on improving enuresis. Materials and Methods: This double-blinded randomized clinical was conducted on 120 children aged 6 to 14 years with mono symptomatic nocturnal enuresis, from 2018 to 2019 in Yazd, Iran. The drug and placebo groups applied 6 drops of the coconut and paraffin oil topically on the suprapubic, sacral and flanks areas one time per night, respectively. Urination pattern was daily recorded for a period of 8 weeks by parents, and after one year, they were asked for any improvement by phone call. Results: The mean frequency of enuresis at the first, second, fourth, and eighth week was lower in the intervention group (p<0.001); this difference between the groups remained after one year. Moreover, there was no side effect requiring any medical attention. Conclusion: Rubbing coconut oil is effective on improving symptom of primary mono symptomatic enuresis if applied every night for 4 weeks on suprapubic, sacral and flanks areas. This may be related to anticholinergic effect of the oil but its persistent effect for longer time after the end of application period, needs to be investigated in other studies.

Effect of oral administration of Triphala, a polyphenol-rich prebiotic, on scalp sebum in patients with scalp seborrhea a randomized clinical trial.

BACKGROUND: Although there are various therapeutic options to control oily skin, they have potential side effects and limitations especially in long-term use. Pre/probiotics may have beneficial effects in atopic dermatitis' acne, dandruff, and seborrhea, demonstrated by some clinical trials. This trial conducted to determine whether the herbal prebiotic Triphala is effective in reducing scalp sebum secretion in patients with scalp seborrhea. METHODS: In this 8 week patient and outcome assessor-blinded, placebo-controlled trial participants with scalp seborrhea aged 14-50 years were randomized to Triphala or placebo groups. 1 g of Triphala (standardized as 91.82 ± 0.5 mg gallic acid) or placebo (wheat flour) were administered BID. Scalp sebum levels were detected objectively using Sebumeter® sm 815, and treatment satisfaction was measured using a score between 0 and 100. [Registration no. IRCT2014070218332N1]. RESULTS: Eighty patients completed the study (40 in Triphala group and 40 in placebo group). Participants in the Triphala group experienced 25.34 scores (95% CI, 0.39-50.29: p = .047) more improvement in scalp sebum levels compared with the placebo group. The mean percentage of patients' satisfaction was 37.91 (24.88) in the Triphala group and 17.89 (25.80) in the placebo group (p = .001). CONCLUSION: Herbal prebiotic Triphala significantly reduced scalp sebum scores compared to placebo.

Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

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.

Efficacy of Pomegranate Seed Powder on Glucose and Lipid Metabolism in Patients with Type 2 Diabetes: A Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial.

INTRODUCTION: Pomegranate is known as a functional food which has multiple health-promoting activities. It has been assessed for patients with metabolic syndrome. Specifically, an antidiabetic activity of its juice and plausible mechanisms for its action have been shown in multitudinous studies. The aim of this study was assessing the effects of complementary treatment with pomegranate seed powder (PSP) oral supplementation on patients with type 2 diabetes mellitus (T2DM). METHODS: Sixty patients were treated for 8 weeks by 5 g PSP or placebo, twice daily. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), total cholesterol, and triglyceride (TG) were recorded as the outcome measures at the beginning and after the intervention. The findings were analyzed using the independent t test and Mann-Whitney U test. RESULTS: After 8 weeks, the mean differences of FBG, HbA1c, cholesterol, and TG were significantly decreased in the PSP group when compared with the placebo group (p value <0.05). In addition, post-intervention values of FBG and HbA1c were significantly lower in patients treated with PSP compared to the placebo group (p values = 0.02 and 0.01, respectively). However, the latter comparison regarding cholesterol and TG showed no significant differences (p values = 0.51 and 0.26, respectively). CONCLUSION: It seems that complementary treatment with PSP may have beneficial effects on FBG and HbA1c of patients with T2DM. However, its effect on TG and cholesterol was equivocal.

Strategies in traditional Persian medicine to maintain a healthy life in the elderly.

As time goes on, a greater number of people experience an age of more than 60 years old and subsequently geriatric syndromes are increasingly more common. Despite recent improvements in modern healthy living, literature on traditional Persian medicine (TPM) about the prevention and treatment of such syndromes and healthy living of the elderly is hardly known. We aimed, in this study, to explore some traditional Persian sources and briefly explain their writers' beliefs on keeping healthy living for old people. We used several TPM sources and literature, and then based on these texts, we collected issues about geriatric temperament and syndromes and classified the results including exercise, nutrition, massage, bathing, aromatherapy, and sleeping. Our search yielded some recommendations about a healthy lifestyle for the elderly, which are in fact equivalent to primary, secondary, and tertiary preventive measures in modern medicine. Our results also showed that they believed such modifications would help the elderly to improve their geriatric conditions. In general, TPM provides some pieces of advice to prevent and treat geriatric syndromes that may be helpful in practice although the scope of their effectiveness remains to be examined in carefully designed randomized controlled trials.

Monitoring of Essential and Toxic Elements in Leaves, Branches, and Stem of Prosopis cineraria (as Anti-Inflammatory) Growing in Iran.

Prosopis cineraria is locally grown which scientific literature present evidence for its anti-inflammatory effect. Monitoring the content of toxic elements is one of the most important aspects to consider medicinal plants' safety before evaluating the pharmaceutical use. The aim of present study was to investigate the level of essential and toxic elements in the leaves, branches, and stem of Prosopis cineraria to assess its health risk. Samples were collected around Bandar Abbas, washed several times, and dried in air for 2 weeks. The dried samples were chopped with stainless steel knife to small pieces and powdered by electrical mortar. Some physical and chemical properties of samples were investigated by chemical methods. Samples were ashed by a programmable electric furnace at 650 °C for 6 h. Then samples were dissolved in 30% HNO3, and the content elements of each sample were determined by inductive coupled plasma optical emission spectrometer (ICP-OES). The tests quality control and the measurement uncertainty were checked through the analysis of certified reference materials of SRM 1515 from NIST and solution standards. Correlation analysis of the obtained results showed a significant difference between leaves, branches, and stem of Prosopis cineraria so that the stem had the high essential and low toxic elements ones in comparison to other parts. The results revealed that the Prosopis cineraria stem is meeting health standards regarding the studied toxic metals.

Whey Protein (Ma'aljobon) as a Complementary Therapy for Treatment of Attention-deficit/ Hyperactivity Disorder (ADHD): A Randomized Open-label Controlled Clinical Trial.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a common, chronic, neurodevelopmental disorder that manifests in childhood with symptoms of hyperactivity, inattention, and impulsivity. Ma'aljobon (a kind of whey protein) that is derived from milk during cheese producing process is a popular dietary traditional product supposed to provide immune modulation and prevent neuropsychiatric disorder. We aimed to evaluate the efficacy of ma'aljobon in management of Attention-deficit/hyperactivity disorder (ADHD). MATERIALS AND METHODS: In this open-label randomized, double arm, and controlled clinical trial, sixty four patients with ADHD who referred to out-patient child and adolescent clinic of Khorshid Hospital of Isfahan, Iran, were randomly assigned in the intervention group (ma'aljobon 25 g once daily plus standard conventional treatment (SCT)) or control group (SCT only) for a period of 8 weeks. Scores of the Strengths and Difficulties Questionnaire (SDQ) and Conners' Continuous Performance Test (CPT) were set as the outcome measures. RESULTS: Parent reported hyperactivity scale of SDQ showed a significant decrease in the intervention group compared to the control group (P=0.04). However, no significant between groups differences were observed in other scales of parent-reported SDQ. Also, according to the results of CPT, there was a significant improvement in the intervention group regarding attention and focus score (P=0.01). CONCLUSION: Ma'aljobon might be considered as a complementary remedy for improving hyperactivity, attention and focus of children with ADHD. However, further researches with larger sample size and longer duration should be done for achieving more reliable results.

The effects of a Melissa officinalis L. based product on metabolic parameters in patients with type 2 diabetes mellitus: A randomized double-blinded controlled clinical trial.

Background Diabetic patients are at increased risk for coronary artery disease. Since phytotherapy has been greatly common, finding safe and effective treatments is of importance. This study aimed to evaluate the effects of a Melissa officinalis L. based product (MO) in patients with type 2 diabetes. Methods A randomized double-blinded controlled study was conducted with 37 dyslipidemic diabetic patients, assigned to either MO or placebo (P) groups receiving two 500 mg capsules daily for 3 months. Finally, 32 cases completed the study and were included in the analysis; MO (n=16) and P (n=16). Results Safe and significant effects in terms of decreasing the serum level of triglyceride (TG) in all patients after 2 months (p-value=0.02) and in patients with higher baseline serum levels of TG (TG≥200 mg/dl) after 3 months (p-value=0.04) were shown in the MO group. However, no metabolic significant changes were seen compared to the control group. Significant decrease in both systolic and diastolic blood pressure from baseline values were also found in patients with higher systolic blood pressure (SBP≥130 mmHg) (p-value=0.02) and those with higher diastolic blood pressure (DBP≥85 mmHg) (p-value=0.02) in the MO group. Conclusion This study showed that MO might be safe and beneficial in decreasing the serum TG level in dyslipidemic diabetic patients. Although, larger long-term studies are required.

The effect of Glycyrrhiza glabra L. on Primary Dysmenorrhea compared with Ibuprofen: A Randomized, Triple-Blind Controlled Trial.

Primary dysmenorrhea is a common gynecological disorder in women of reproductive age. Despite the effective conventional treatments such as nonsteroidal anti-inflammatory drugs and oral contraceptives, researchers have always been looking for alternative drugs due to the adverse effects and limited efficacy of these medications. Glycyrrhiza glabra L. (G. glabra), commonly known as Licorice, has been applied for a long time as a plant with multiple therapeutic potencies in Traditional Persian Medicine (TPM). This study was designed to evaluate the effect of the G. glabra on primary dysmenorrhea. Sixty patients with moderate and severe dysmenorrhea were randomly divided into two groups; one group received 400 mg Ibuprofen tablets every 8 h and placebo syrup and the other received 5 cc of G. glabra syrup two times a day and placebo tablets. The patients took the drugs from the first day of menstruation to fifth for two consequent cycles. The primary pain intensity and its changes were evaluated in each group and compared between two groups. The reduction of pain intensity was 5.85 (±3.11) in the G. glabra group compared with 6.92 (±1.87) in the Ibuprofen group (p < 0.001). No significant difference detected between the two groups (p = 0.151). No serious side effects were reported during the study. This study suggests that we can use G. glabra to relieve pain in the patients with primary dysmenorrhea; although studies with a larger sample size may lead to more comprehensive perceptions about the efficacy of G. glabra.

Aloysia citriodora Palau (lemon verbena) for insomnia patients: A randomized, double-blind, placebo-controlled clinical trial of efficacy and safety.

Aloysia citriodora (A. citriodora) has a long history of traditional use for sedation and treatment of insomnia in different societies. This study was carried out to assess the efficacy of A. citriodora in patients with insomnia. One hundred patients were randomly divided into two groups of A. citriodora (total essential oil 1.66 mg/10 ml and total amount of flavonoid in terms of quercetin 3.22 mg/10 ml of the syrup) and placebo. They were advised to use 10 cc of the syrups; an hour before the bedtime for a period of 4 weeks. Participants were assessed using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) questionnaires at the baseline and then 2 and 4 weeks after the enrollment. Mean scores of global PSQI and its four components including sleep latency, habitual sleep efficiency, daytime dysfunction, and subjective sleep quality and also ISI score in the A. citriodora group improved significantly after 4 weeks of treatment when compared with the placebo group (p < 0.001, for all of them). Also, improvement of global score of PSQI and ISI was observed in the intervention group as compared with the placebo group, 2 weeks after the enrollment (p < 0.001). The results of this study showed that oral intake of A. citriodora can be suggested as a complementary treatment for patients with insomnia.

Effect of Oral Herbal Medicament on Scalp Seborrhea and Gastrointestinal Symptoms in a Male Patient: A Case Report.

A 32-yr-old man with a 10-yr history of scalp seborrhea referred to Skin and Stem Cell Research Center, Tehran, Iran, in 2015. He suffered from scalp seborrhea. Concurrent gastrointestinal symptoms and the changes in the clinical symptoms after consumption of the polyherbal traditional drug called Triphala are discussed. The scalp sebum was measured with a Sebumeter SM815. Gastrointestinal symptoms were followed using a valid questionnaire. After two months of treatment, scalp sebum secretion had decreased substantially. The patient also experienced remarkable improvement in gastrointestinal symptoms. Considering the positive effect of this known and safe polyherbal drug on skin sebum, it is an appropriate option for detailed large-scale clinical trials.

Investigating the effectiveness of the Trigonella foenum-graecum L. (fenugreek) seeds in mild asthma: a randomized controlled trial.

BACKGROUND: Asthma is one of the important chronic diseases. The asthma prevalence is increasing in last decades. Despite the presence of good controller drugs like corticosteroids, about 60% of asthmatic patients use alternative medicine. This study was done to determine the effectiveness of Tregonella foenum graceum (fenugreek) seeds in mild asthma. METHODS: It is a double blind trial with placebo effect. One of the ancient prescriptions from Persian Medicine was selected. The participants were divided to three groups randomly. On group received fenugreek syrup one received honey syrup and the third received placebo. Duration of treatment was 4 weeks. Quality of life, Lung function tests and IL-4 levels were evaluated before and after treatment. RESULTS: From 90 participants to study 79 completed the process. After study there was significant increase in quality of the life and lung function tests and IL-4 levels in fenugreek and honey groups. CONCLUSION: FEV1 level was improved more than 10% in fenugreek group. Treatment was well tolerated. No serious side effects were reported during the study. The aqueous extract of fenugreek seeds appears to be effective and safe in treatment of mild asthma.Trial registration The study was recorded with the Iranian Registry of Clinical trials [http://www.irci.ir], registration code: IRCT2016011325991N1.

A systematic review of the efficacy and safety of Rosa damascena Mill. with an overview on its phytopharmacological properties.

Rosa damascena Mill. is one of the most famous ornamental plants cultivated all over the world mostly for perfumery industries. Traditionally it has been used as an astringent, analgesic, cardiac and intestinal tonic.The paucity ofauthoritative monographs urged usto summarize its clinical effectiveness and safety with acomprehensive review of the literature. "PUBMED", "SCOPUS", "WEBOF SCIENCE" were searched up to April 30, 2017 with search terms:("Rosa damascena" OR "Damask Rose"). All human studies with any mono-preparation were included. In vitro and animal studies from "PUBMED"were also reviewed and outlined. Of "1000" identified publications, twelveeligibleclinical trials were retrieved. Antimicrobial, anti-inflammatory, antioxidant, anticancer, protective neuronal, cardiac, gastrointestinal and hepatic effectsin 30 in vitro and 21 animal studies were also shown. there are promising evidences for the effectiveness and safety of Rosa damascena Mill in pain relief, but confirmatory studies withstandardized products is suggested.

Causes of infertility in view of Iranian traditional medicine: A review.

Infertility is one of the most important reproductive health concerns in the conventional medicine. Iranian traditional medicine presents different viewpoints in this regard which they could be of benefit and a good guide for the society of medicine. This study sought to provide the comprehensive investigation on the causes of infertility according to Iranian traditional medicine for understanding of old sages' ideas and categorizing of the causes of infertility. In this narrative review, we searched causes of infertility in traditional medicine books and available articles in this field. Iranian traditional physicians have investigated the causes of infertility in couples and attributed them to male and female causes. They have divided the main causes of infertility in both sexes into structural and functional abnormalities, that both traditional medicine and conventional medicine have a lot of participations, but the traditional medicine believes holistic approach in the treatment of diseases and the involvement of all parts of the body particularly specialty board members (heart, liver, brain, ovary, and testicles) in the proper conduct activities in different parts of the body such as reproduction system. There is also special attention to temperament Mizaj disorders. Given the numerous commonalities existing between traditional and conventional medicine in categorizing the causes of infertility, Iranian traditional medicine methods can be applied as a complementary solution in infertility. It could be also subject to further research and investigation due to its opposition to modern medicine in some regards.

Effects of rhubarb (Rheum ribes L.) syrup on dysenteric diarrhea in children: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Rheum ribes L. is a plant native to China, Iran, Turkey, India, and a few other countries. Antidiarrheal activity is considered to be one of its important properties according to various systems of traditional medicine. An increasing rate of bacterial resistance to antibiotics has led to treatment failure in some cases of shigellosis in children, and underlines a need for safe, efficient and valid options. OBJECTIVE: The purpose of this study is to evaluate the efficacy of R. ribes syrup as a complementary medicine for treatment of shigellosis in children. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This randomized, double-blind, placebo-controlled trial started with a group of 150 children aged between 12-72 months with suspected Shigella dysentery. R. ribes syrup or placebo syrup was administered to the intervention and control groups, respectively for 5 days. In addition, the standard antibiotic treatment (ceftriaxone for the first 3 days and cefixime syrup for 2 further days) was administered to both groups. MAIN OUTCOME MEASURES: Body temperature, abdominal pain, need for antipyretics, defecation frequency, stool volume and consistency and microscopic stool examination were recorded as outcome measures. Any observed adverse effects were also recorded. RESULTS: Mean duration of fever and diarrhea in the R. ribes group was significantly lower than that in the placebo group (P = 0.016 and 0.001, respectively). In addition, patients in the R. ribes group showed shorter duration of need for antipyretics and shorter duration of abdominal pain (P = 0.012 and 0.001, respectively). However, there were no significant differences between the two groups regarding the microscopic stool analyses. Furthermore, no adverse effect was reported. CONCLUSION: R. ribes syrup can be recommended as a complementary treatment for children with Shigella dysentery. TRIAL REGISTRATION: Iranian Registry of Clinical Trial: IRCT2014070518356N1.

Biological Effects and Clinical Applications of Dwarf Elder ( Sambucus ebulus L): A Review.

Dwarf elder ( Sambucus ebulus L) is one of the best known medicinal herbs since ancient times. In view of its benefits as a widely applicable phytomedicine, it is still used in folk medicine of different parts of the world. In addition to its nutritional values, dwarf elder contains different phytochemicals among which flavonoids and lectins are responsible for most of its therapeutic effects. Dwarf elder has been used for different ailments including: joint pains, cold, wounds, and infections. Nevertheless, recent evidence has revealed its potentials for making attempts at treating cancer and metabolic disorders. This review aimed to provide a comprehensive description of dwarf elder regarding its traditional uses and modern findings which may contribute to the development of novel natural-based therapeutic agents.

Prevention of Disease in Travel from the Perspective of Iranian Traditional Medicine.

BACKGROUND: Due to the high volume of travel and the spread of various diseases as well as disorders during a trip, one of the major concerns for travelers is the issues related to disease spread, control, and prevention. The approach of philosophers and traditional physicians along with hygiene measures were noted as trip recommendations in their textbooks. Considering negligence in disease prevention and the lack of dedicated and systematic discussion on this topic, this article aims at collecting their experiences as a practical reference point. METHODS: This qualitative study, review articles in the field of traditional medicine and search in authentic books on traditional medicine. The gathered data were initially analyzed and then categorized. RESULTS: Results were described in several sub-categories, including general recommendation, food and drinking recommendations during travel, prevention of dehydration in warm and cold conditions, poisoned and polluted air recommendations, management of sea passengers, fatigue due to travel, and the prevention of skin diseases. CONCLUSION: These measures are efficient interventions and cost-effective, which provide guidelines for traveler's health during a trip.

The Effect of Massage Therapy on Children's Learning Process: A Review.

BACKGROUND: Massage therapy is the scientific manipulation of the soft tissues of the body for normalizing those tissues and consists of manual techniques that include applying fixed or movable pressure, holding, and/or causing movement of or to the body. There are more than 1500 massage training centers or schools in the United States. Several studies evaluated the effect of massage on elevating child health and to treat various disorders. METHODS: In this review, keywords related to the subject were searched in ScienceDirect, Google, Google Scholar, PubMed, and Cochrane library. The data were classified, analyzed, and interpreted. RESULTS: Studies showed massage in pupils could increase blood circulation in the body, make breathing better, better growth, increased concentration and IQ, improved immune system, reduction in stress, pain, anger, and aggressiveness as well as allowing restful sleep. All these together would elevate their learning ability. In addition, massage therapy is studied on a variety of disorders such as blood pressure, rheumatoid arthritis, autism, cystic fibrosis, back pain, nervous pain, muscle and joints pain and headache. CONCLUSION: To promote health in pupils, it I proposed to introduce the concept of "classmates massage during break" program. Such groups massage therapy, next to its health benefits, would contribute to their peace, tranquility, and teamwork. A similar program is running in Australia as well as few other countries under the codename "massage in schools program (MISP)". This program has had a tangible effect on children's capabilities.

Efficacy and short-term safety of topical Dwarf Elder (Sambucus ebulus L.) versus diclofenac for knee osteoarthritis: A randomized, double-blind, active-controlled trial.

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.