Evaluating the effects of dark chocolate formulated with micro-encapsulated fermented garlic extract on cardio-metabolic indices in hypertensive patients: A crossover, triple-blind placebo-controlled randomized clinical trial.

This study aimed to investigate the health-related effects of microencapsulated fermented garlic extract (FGE) containing dark chocolate in hypertensive adults. For this purpose, 36 hypertensive adults (15 males vs. 21 females) were randomized to receive the FGE (5 g/day) dark chocolate containing 650 mg of FGE powder or the placebo. Intervention periods lasted for 6 weeks and were separated by a 3-week wash-out period. The response variables included blood pressure, anthropometric indices, lipid profile, and inflammatory and oxidative stress indices. Statistical analyses were performed using the Pkcross procedure, and Cohen's d was estimated for all response variables. There was no significant inter-period difference between the mean changes of body weight, waist circumference, and body mass index (BMI). Furthermore, no significant change was confirmed in participants' blood pressure, triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), serum homocysteine, high-sensitive c-reactive protein (hs-CRP), malondialdehyde (MDA), and total antioxidant capacity (TAC). It seems that the dose of FGE used in this study was not sufficient to cause any significant changes in the outcomes. Therefore, further studies with dose-response designs and longer durations are recommended.

Pollens in therapeutic/diagnostic systems and immune system targeting.

Pollen is an excellent natural substance that plays an essential role in the reproduction of plants. In this review, we explain the structure, compositions, and characteristics of pollens. We consider pollen as a multifunctional tool that can be used in therapeutic/diagnostic systems. This microcapsule can be used in the forms of the hollow microcapsule, microgel, and composite, and also can be a tool for the synthesis of micro/nanostructures in various medical applications and used for the production of genetically modified plants that affect human health. In addition, we investigate the capability of this multifunctional tool in the immune system targeting that acts as an immunomodulator. In all applications and capabilities, we explain the potential of using nanostructures as parts of these systems and as auxiliary tools for promoting the applications of pollen. It is expected that soon, with the help of pollen-based therapeutic/diagnostic systems with the ability to immune system targeting, we will achieve effective and targeted therapeutic systems for the treatment of inflammatory and autoimmune diseases. In this paper, we suggest some ideas that may be a new step for future researches.

Anti-Inflammatory Activity and Quality Control of Erysimum cheiri (L.) Crantz.

Wallflower (Erysimum cheiri) is employed as a popular herbal drug in traditional Persian medicine. Topical formulations including cerates, lotions, sitz baths, and poultices for inflammatory disorders such as arthritis, anal fissure, endometriosis, and mastitis are known. However, there is no monograph in current pharmacopoeia for the wallflower drug. The present study is aimed to screen in vitro anti-inflammatory activity of wallflower and perform quality control and characterization tests for different organs of the herb. In this regard, albumin denaturation activity, macroscopic and microscopic, phytochemical, HPTLC, and FT-IR characteristics were investigated. Wallflower showed strong anti-inflammatory activity compared to diclofenac sodium. The root (1.25, 2.5, and 5 mg/mL) and flower (10 mg/mL) extract exhibited higher anti-inflammatory activities than that of other plant organs at the same concentrations. Moreover, total ash was found higher in aerial parts (21.52 ± 0.06%) than flower (11.01 ± 0.03%), root (5.03 ± 0.03%), and seed (6.95 ± 0.06%), while water-soluble ash was higher in seed (34.89 ± 0.26%) than flower (5.00 ± 0.03%), aerial parts (7.16 ± 0.06%), and root (5.04 ± 0.01%). Acid-insoluble ash and sulphated ash were higher in root (9.50 ± 0.04%) and aerial part (28.37 ± 0.57%), respectively. In addition, loss on drying was ranged from 2.20 ± 0.20% in flowers to 6.00 ± 0.10% in aerial parts. On the other hand, HPTLC analysis verified cardenolide compounds in all organs of the herb, and quercetin was detected in the flavonoid fingerprint of acid hydrolysed flowers. According to FT-IR results, the observed spectral region at ~3500 cm-1 attributed to -OH stretching vibration. Also, C-H (~2900-2950 cm-1), isothiocyanate (~2340 cm-1), -C=O (~1740 cm-1), conjugated C=C of the aromatic ring (~1650 cm-1), and structure of the aromatic group (~1200-1000 cm-1) were monitored. This work is the first study to the best of our knowledge, suggesting wallflower as a potential drug candidate with the basis for a monograph in addition to initial in vitro anti-inflammatory data.

Effect of a novel herbal vaginal suppository containing myrtle and oak gall in the treatment of vaginitis: a randomized clinical trial.

BACKGROUND: Uncomplicated infections such as candidiasis, bacterial vaginosis (BV), or trichomoniasis are easy to diagnose and treat. However, about 8% of patients will have a more complicated course with failure to respond to treatment or rapid recurrence of symptoms. There are many suggestions in Traditional Persian Medicine like myrtle (Myrtus communis L.) and oak gall (Quercus infectoria G.Olivier) for treatment of vaginitis. OBJECTIVES: A clinical trial was designed to assess the efficacy of a novel herbal suppository, containing myrtle and oak gall (MOGS) in treatment of vaginitis. METHODS: In a parallel randomized clinical trial, 120 women with vaginitis were randomly assigned to MOGS, metronidazole, or placebo. Formulation was simulated from traditional Persian manuscripts and MGOS was prepared after pharmaceutical optimization processing as well as quantification of gallic acid by HPLC. The study was double-blind for MOGS and placebo and single-blind for metronidazole group. RESULTS: MOGS effectively improved vaginal discharge (p = 0.024 for BV and 0.018 for trichomoniasis) and pH (compared to placebo (p = 0.013) and metronidazole (p = 0.001)). Both MOGS and metronidazole could reverse whiff test. Metronidazole was the best medication for making Nugent score negative (p = 0.005) as well as the best therapy according to laboratory findings to treat BV in comparison with placebo (p = 0.021). While for trichomoniasis, MOGS could improve the disease more successfully (p = 0.001). Both MOGS and metronidazole treated mixed vaginitis (p = 0.002). CONCLUSION: MOGS would be a chance for developing new treatment for trichomoniasis.

Neuroprotective Potential of Curcumin-Loaded Nanostructured Lipid Carrier in an Animal Model of Alzheimer's Disease: Behavioral and Biochemical Evidence.

Alzheimer's disease (AD) is one of the most common neurodegenerative diseases and is caused by accumulation of amyloid-ß (Aß) peptide and is associated with neurological abnormalities in learning and memory. The protective role of curcumin on nerve cells, along with a potent antioxidant and free radical scavenging activity, has been widely studied. However, its low bioavailability and limited transport ability across the blood-brain barrier are two major drawbacks of its application in the treatment of different neurodegenerative diseases. The present study was designed to improve the effectiveness of curcumin in the treatment of Aß-induced cognitive deficiencies in a rat model of AD by loading it into nanostructured lipid carriers (NLCs). The accumulation rate of curcumin (505.76±38.4 ng/g-1 h) in rat brain, as well as its serum levels, were significantly increased by using curcumin-loaded NLCs. The effective role of NLCs for brain delivery of curcumin was confirmed by reduced oxidative stress parameters (ROS formation, lipid peroxidation, and ADP/ATP ratio) in the hippocampal tissue and improvement of spatial memory. Also, histopathological studies revealed the potential of Cur-NLCs in decreasing the hallmarks of Aß in AD in the animal model. The result of studying the neuroprotective potential of Cur-NLC in both pre-treatment and treatment modes showed that loading curcumin in NLCs is an effective strategy for increasing curcumin delivery to the brain and reducing Aß-induced neurological abnormalities and memory defects and that it can be the basis for further studies in the area of AD prevention and treatment.

Evaluation of the effect of topical chamomile (Matricaria chamomilla L.) oleogel as pain relief in migraine without aura: a randomized, double-blind, placebo-controlled, crossover study.

Phytotherapy is a source of finding new remedies for migraine. Traditional chamomile oil (chamomile extraction in sesame oil) is a formulation in Persian medicine (PM) for pain relief in migraine. An oleogel preparation of reformulated traditional chamomile oil was prepared and then standardized based on chamazulene (as a marker in essential oil) and apigenin via gas chromatography (GC) and high-performance liquid chromatography (HPLC) methods, respectively. A crossover double-blind clinical trial was performed with 100 patients. Each patient took two tubes of drug and two tubes of placebo during the study. Visual analog scale (VAS) questionnaires were filled in by the patients and scores were given, ranging from 0 to 10 (based on the severity of pain) during 24 h. Other complications like nausea, vomiting, photophobia, and phonophobia were also monitored. There was 4.48 ± 0.01 µl/ml of chamazulene and 0.233 mg/g of apigenin in the preparation (by correcting the amount with extraction ratio). Thirty-eight patients in the drug-placebo and 34 patients in the placebo-drug groups (a total number of 72 patients as per protocol) completed the process in the randomized controlled trial (RCT). Adapted results from the questionnaires showed that pain, nausea, vomiting, photophobia, and phonophobia significantly (p < 0.001) decreased by using chamomile oleogel on the patients after 30 min. Results supported the efficacy of chamomile oleogel as a pain relief in migraine without aura.

Traditional neurotherapeutics approach intended for direct nose to brain delivery.

ETHNOPHARMACOLOGICAL RELEVANCE: Nasal delivery systems have a significant role in Persian traditional medicine. Most of them were utilized for central nervous system (CNS)-related disorders. In modern medicine, nasal drug delivery systems for brain delivery are highly regarded. AIM OF THE STUDY: Despite recent advances in drug delivery to the (CNS), delivery of therapeutics to the brain remains a major challenge because of the blood brain barrier (BBB). There are several mechanisms which regulate the drug transfer across the BBB. Local administration methods of therapeutic agents are often associated with adverse events, while the intranasal pathway has been suggested as a non-invasive alternative route to deliver drugs to the brain. This route can bypass the BBB and deliver drug molecules directly to the CNS. There are different nasal formulations have been addressed in Persian traditional pharmacopeias. The present review attempt to explore the famous and practical Qarabadin to find ancient nasal dosage forms. MATERIALS AND METHODS: With an explore on traditional herbs in google scholar, scopus and science direct, we have found some original and review articles which have demonstrated our findings on the use of traditional herbs for CNS disorders. Four encyclopedia of multi-component formulations, including Qarabadin Salehi (1766), Qarabadin kabir (1781),Qarabadin Ghaderi (18th century), and Qarabadin Azam (1853), were searched for nasal formulations having CNS-related indications. Formulations were categorized based on dosage forms, and also, diseases which they were suggested for. While the names of illnesses were in ancient terminology of Traditional Medicine, they were translated to modern medical terminology by comparing their definitions, signs, and symptoms from two medical systems. Typical samples of each dosage form have been mentioned with details like amount of ingredients, scientific names of plants, and considerations pertaining to preparation or usage. RESULTS: Among all traditional nasal formulations, seven types were found that is used for sicknesses relating to CNS including Saoot, Nafookh, Atoos, Nashoogh, Shamoom, Lakhlakheh, and Bakhoor. CONCLUSIONS: The findings of this study reveal the physicochemical characteristics of each formulation, route of administration, and type of disease which they are suitable and also present some famous formulations.

Fingerprints, Pharmaceutical and Radical Scavenging Activity Evaluation of an Alzheimer-Targeted Herbal Preparation.

BACKGROUND: As the most common form of dementia, Alzheimer disease is characterized by progressive loss of memory and deterioration of cognitive functions. It is predicted that about 75.63 million people would suffer from dementia by 2030. Apart from conventional remedies, the application of herbal medicines is on the rise. There are numerous natural medicaments reported in the traditional manuscript of Persian medicine. Accordingly, in the present study, the intended remedy was selected and an appropriate pharmacognostical and pharmaceutical evaluations were performed. METHODS: By searching through the traditional pharmaceutical manuscripts such as Qarabadeen-e-Salehi, Qarabadeen-e-Azam, Qarabadeen-e-Ghaderi and Canon of Medicine, a simple but proven compound remedy (frankincense and black pepper) was selected. A floating tablet was designed and formulated from those herbal components. Related pharmaceutical assessments such as weight variation, hardness, friability, and disintegration tests as well as pharmacognostical evaluations such as microscopic characterization, TLC, GC/MS, FT/IR fingerprints, and radical scavenging activity assessment (DPPH) were performed. RESULTS: The resulting formulation, as a floating tablet, included 60% of frankincense gum and 15% of black pepper along with appropriate pharmaceutical ingredients (weight variation: 0.219±0.004 g, hardness: 6.50±0.67, friability: 0.45%, disintegration time >30 min). Microscopic characterization demonstrated stone cells, calcium oxalate crystals, sclereids of endocarp and pitted cells of mesocarp of pepper fruits as well as oil drops of frankincense gum. TLC fingerprinting showed classes of secondary metabolites related to both components. GC/MS analysis revealed Acetyl acetate and trans-Caryophyllene as the main constituent. Moderate radical scavenging activity (IC50 >100 µg/ml) was calculated for the methanol extract of tablets. CONCLUSION: Carrying out and validating a GC method for standardization of the formulated tablet, and having the structure for the effectiveness of these medicinal herbs in Alzheimer may be the horizon for a new Alzheimer-targeted medicine.

Phytochemistry and Phytotherapeutic Aspects of Elaeagnus angustifolia L.

Persian or Russian olive (Elaeagnus angustifolia L.), from the family Elaeagnaceae, is a nitrogen-fixing thorny shrub extensively used in traditional medicine to alleviate pain and treat rheumatoid arthritis, osteoarthritis, gastrointestinal problems, fever, and asthma. The current review has tried to give a concise overview of the phytochemistry and pharmacological properties of the plant from published data. Accordingly, published English literatures on Elaeagnus angustifolia were gathered from popular databases such as PubMed, Scopus, Web of Science, and ScienceDirect up to 31 December 2015. In accordance with traditional and ethnopharmacological uses, different extracts of E. angustifolia have been known for their antioxidant, anti-inflammatory, anti-nociceptive, antimicrobial, muscle relaxant, anti-ulcer and wound-healing capabilities. Additionally, cardioprotective, antitumor and anti-mutagenic effects of the herb have been demonstrated by current assessments. Despite numerous experimental studies, there is a notable lack of profound and comprehensive clinical trials as well as critical research on E. angustifolia toxicity and teratogenicity. With reference to various pharmacological effects based on experimental and animal investigation, it is worthy to mention a frame for respective clinical studies in further studies.