Efficacy of Honey-based Ophthalmic Formulation in Patients with Corneal Ulcer: A Randomized Clinical Trial.

AIM: The aim of this study was to evaluate the efficacy of honey-based ophthalmic drop in patients with foreign body induced corneal ulcer. BACKGROUND: Honey is traditionally used for skin, mucosal and corneal ulcers. Its use is well studied in human skin and mucosal ulcers and animal model of corneal ulcer with promising effects. METHODS: In this randomized clinical trial, 50 patients with foreign body induced corneal ulcer were allocated to receive 70% sterile honey-based ophthalmic formulation or 0.3% ophthalmic ciprofloxacin, as the standard treatment every 6 hours. All the patients were examined for the size of corneal epithelial defect, corneal infiltration and depth and followed on a daily basis until complete healing. Duration for complete healing was considered as the outcome measure. Smear, culture, antibiogram and minimum inhibition concentration (MIC) tests were performed for honey and ciprofloxacin in all patients. RESULTS: The average durations of complete healing of corneal epithelial defect in the honey and ciprofloxacin groups were 3.88 ± 3.44 vs. 6.32 ± 3.69days, respectively (p=0.020). No significant difference was observed between two groups regarding an average duration of healing of corneal infiltration (8.12 ±1.94 days vs. 8.64±2.15 days, p=0.375). MIC of honey for pseudomonas aeruginosa was 60%w/w, for E.Coli 40% w/w, and for staphylococcus aureus 30% w/w. CONCLUSION: Honey based ophthalmic drop can acceleratethe corneal epithelial defect healing in patients with foreign body induced corneal ulcer, compared to ophthalmic ciprofloxacin as a standard treatment. The study was registered in Iranian registry of clinical trial center (IRCT) with registration number IRCT2015020120892N1.

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.

Reformulation of Traditional Chamomile Oil: Quality Controls and Fingerprint Presentation Based on Cluster Analysis of Attenuated Total Reflectance-Infrared Spectral Data.

Herbal oils have been widely used in Iran as medicinal compounds dating back to thousands of years in Iran. Chamomile oil is widely used as an example of traditional oil. We remade chamomile oils and tried to modify it with current knowledge and facilities. Six types of oil (traditional and modified) were prepared. Microbial limit tests and physicochemical tests were performed on them. Also, principal component analysis, hierarchical cluster analysis, and partial least squares discriminant analysis were done on the spectral data of attenuated total reflectance-infrared in order to obtain insight based on classification pattern of the samples. The results show that we can use modified versions of the chamomile oils (modified Clevenger-type apparatus method and microwave method) with the same content of traditional ones and with less microbial contaminations and better physicochemical properties.

Report - Renovation of a traditional Ergh-al-Nassa pill (Hab) to a standard Pharmaceutical molded tablet.

The Ergh-al-Nassa pill (Hab) is a traditional combination suggested as one of the most effective preparations useful for treatment of sciatica. Although traditional preparations can be applied as new therapeutic drugs for investigations and clinical trials, they need to be reformulated to achieve pharmacopoeial standards for modern medicine. In this research, based on seven traditional Persian pharmacopeias for Ergh-al-NassaHab, nine different molded tablets were reformulated. Each formulation comprised the same amount of colchicum, ginger, aloe and yellow myrobalan fruit. Sweet almond oil had to be added in the maximum amount needed to be absorbed by the yellow myrobalan fruit according to its particle size (30-40 mesh sizes). The studies were performed in order to optimize the formulation process according to the role of three levels in particle size of the herbal ingredients (60-70, 80-100, 100-150 mesh sizes) and three levels of initial water for granulation. The molded tablets were evaluated according to standard quality controls for tablets (mass uniformity, LOD, hardness, friability, and disintegration time at 20 and 30 min). Myrobalan powdered to 30-40 mesh size absorbed the maximum amount of sweet almond oil (1:0.75 w/v). The best formulations occurred when the particle size of colchicum, ginger, and aloe was 60-70 mesh size with an initial moisture content of 0.47 ml per 1g of dried powder. The outcome of this research is a pharmaceutical standardized formulation from the traditional Ergh-al-Nassa pill which can be suggested as a sample drug discovery based on traditional knowledge.

A review on the management of migraine in the Avicenna's Canon of Medicine.

Migraine is a common type of headache which has a deep history dating back thousands of years. Avicenna (980-1032), a Persian scholar, made a great contribution to neurology including headache and migraine. The aim of this study is to consider Avicenna's description about migraine (Shaghighe in Persian language) including definition, etiology and intervention. Also, his definition and treatment approaches were considered based on current concepts and findings. Although Avicenna believed in humoral theory and divided migraine into two categories, hot and cold, and suggested special treatments for them as well as general considerations, most of his definitions and explained pathologies are supported by current concepts of medicine. He believed that the migraine can result from bone of skull and also intra-parenchymal; or from skull underneath membrane (dura-mater); or reaching substances from the painful side or from outer vein and arteries (extra cranial); or from brain and meninges (pia-mater). Furthermore, current findings show most medicinal plants mentioned by Avicenna for the treatment of migraine can have potentially significant effects such as remedies which stop central and peripheral sensitization [anti-neuroinflammatory agents, decreasing nitric oxide level, cyclooxygenase (COX)-2 inhibitors], as well as serotonergics, neuroprotective agents and analgesics.

Potential effect and mechanism of action of topical chamomile (Matricaria chammomila L.) oil on migraine headache: A medical hypothesis.

Migraine is a chronic recurring headache for which no complete treatment has been found yet. Therefore, finding new treatment approaches and medicines is important. In this review, we consider the probable mechanism of action of a traditional and ethnic formulary of chamomile extract in sesame oil as a new topical medication for migraine pain relief. Chamomile oil is prepared in Traditional Persian Medicine by boiling aqueous extract of chamomile in sesame oil. To optimize the procedure, we can use a Clevenger-type apparatus to extract the essential oil and add it to the end product. The preparation includes both essential oils (chamazulene and bisabolol oxide) and polyphenols (a flavonoid such as apigenin and its derivatives). It probably possesses pain relief effects for migraines because of the following properties: (1) chamazulene and apigenin, which inhibit iNOS expression in activated macrophages and can lead to the prohibition of NO release and synthesis; (2) chamomile flavonoids, which have a strong inhibitory effect on endogenous prostaglandin E2 (PGE2) levels in RAW 264.7 macrophages and can play the role of selective COX-2 inhibitor; (3) chamomile polyphenols, which possess anti-inflammatory effects due to the inhibition of pro-inflammatory biomarkers in THP1 macrophages and which can reduce inflammation in neurovascular units (NVU) at the site of migraine pain; (4) chamomile, which has neuroprotective effects because of reduced NO levels; (5) sesamine in sesame oil, which possesses an anti-inflammatory effect. These effects are supported by main pathophysiological theories of migraine such as neural and sensitization theories. Chamomile oil is a traditional formulation still used in Iran as an ethno-medicine. Because of the mentioned mechanisms of action, it can be hypothesized that chamomile oil is a novel medicine for the relief of migraine pain.

Enhancement of follicular delivery of finasteride by liposomes and niosomes 1. In vitro permeation and in vivo deposition studies using hamster flank and ear models.

Finasteride is indicated orally in the treatment of androgenetic alopecia and some other pilosebaceous unit (PSU) disorders. We wished to investigate whether topical application of finasteride-containing vesicles (liposomes and niosomes) could enhance drug concentration at the PSU, as compared to finasteride hydroalcoholic solution (HA). Liposomes consisted of phospholipid (dimyristoyl phosphatidylcholine (DMPC) or egg lecithin):cholesterol:dicetylphosphate (8:2:1, mole ratio). Niosomes were comprising non-ionic surfactant (polyoxyethylene alkyl ethers (Brij series) or sorbitan monopalmitate):cholesterol:dicetylphosphate (7:3:1, mole ratio). Vesicles were prepared by the film hydration technique and characterized with regard to the size, drug entrapment efficiency and gel-liquid transition temperature (T(c)). In vitro permeation of (3)H-finasteride through hamster flank skin was faster from hydroalcoholic solution (0.13 microg/cm(2)h) compared to vesicles (0.025-0.058 microg/cm(2)h). In vivo deposition of (3)H-finasteride vesicles in hamster ear showed that liquid-state vesicle, i.e. those made of DMPC or Brij97:Brij76 (1:1), were able to deposit 2.1 or 2.3% of the applied dose to the PSU, respectively. This was significantly higher than drug deposition by gel-state vesicles (0.35-0.51%) or HA (0.76%). Both in vitro permeation and in vivo deposition studies, demonstrated the potentials of liquid-state liposomes and niosomes for successful delivery of finasteride to the PSU.