Ravi Shrivastava

Treatment of Aphthous Stomatitis with topical Alchemilla vulgaris in glycerine.

AbstractBackground and objective: Recurrent aphthous ulceration is the most common oral mucosal disease known. It presents as three types: minor (most prevalent), major and herpetiform. However, there are no well established effective and reliable treatments of this condition. Alchemilla vulgaris (Lady’s Mantle) has traditionally been used in oral hygiene and was recently shown to accelerate wound healing when used in combination with glycerine. The objective of this study was to determine whether this combination is effective in the treatment of the most prevalent form of aphthous ulcers. Methods: An open-label study was conducted in 48 otherwise healthy male and female patients aged 4–44 years to determine the putative healing properties and tolerability of a standard 3% extract of A. vulgaris in glycerine (Aphtarine®) on common minor oral ulcers. Patients with major or herpetiform ulcers were excluded from the study. Results: Topical application three times daily of Aphtarine® gel to minor mouth ulcers relieved discomfort and produced complete healing in the majority of patients (60.4%) within 2 days and in 75% within 3 days, compared with 10.4% and 33.3%, respectively, without treatment and 15% and 40%, respectively, with commonly available treatments. Most patients appreciated the product’s ease of application, taste and texture. Aphtarine® was well tolerated locally and most patients rated the product good to excellent overall. Conclusion: Aphtarine® is a safe, well tolerated and highly effective promising new treatment for healing common mouth ulcers.

Evidence for growth-promoting effects of Omega n −3 fatty acids alone and in combination with a specific vitamin and mineral complex in rat neuroblastoma cells

Abstract The beneficial effects of Omega n - 3 polyunsaturated fatty acids ( n - 3 PUFA) in situations of cognitive impairment may be associated with enhanced neuronal growth. Since neuronal growth is impaired in n - 3 PUFA deficiency, and enhanced by certain vitamins and trace elements, the effects of n - 3 PUFA, vitamin and mineral cell complex (VMC) and their association on neuronal growth were investigated in cultured rat neuroblastoma cells. Treatment of cells for 3 days with n - 3 PUFA significantly enhanced neurite length without affecting the number of neurites or cells. VMC significantly increased cell number without affecting neurite length or their number. Combined n - 3 PUFA and VMC significantly enhanced all three growth parameters. The data confirm the growth promoting effects of n - 3 PUFA and VMC in cultured neurons over a relatively short time frame.

a new generation of topical chronic wound treatments containing specific MMP inhibitors

License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Chronic Wound Care Management and Research 2014:1 31–40 Chronic Wound Care Management and Research Dovepress

Paracetamol potentiates isaxonine toxicity in vitro

The toxicity of isaxonine alone and in combination with the known glutathione depletor, paracetamol, was evaluated using rat hepatocyte primary cultures in vitro by measuring morphometric parameters and the leakage of intracellular lactate dehydrogenase into the culture medium. No cytotoxicity was observed with isaxonine at concentrations up to 10(-3) M, whereas paracetamol was cytotoxic at concentrations above 0.6 x 10(-3) M in the culture medium. Paracetamol cytotoxicity (0.6-3.3 x 10(-3) M) was enhanced in the presence of a non-cytotoxic concentration of isaxonine (10(-7) M). Furthermore cytotoxicity was observed when cells were exposed to a combination of non-cytotoxic concentrations of the paracetamol (0.3 x 10(-3) M) and isaxonine (10(-7) M). These findings demonstrate that isaxonine has no direct cytotoxic effect even at high concentrations. However co-administration of isaxonine with paracetamol greatly potentiates cytotoxicity. We suggest that this effect may be related to glutathione depletion within the cell but additional studies are required to verify this hypothesis.

Clinical Efficacy of a Dual Action, Topical Anti-edematous and Antiinflammatory Device for the Treatment of External Hemorrhoids

Objective: External hemorrhoids are enlarged, bulging blood vessels in and around the anus and lower rectum. They associate several pathologies such as engorged, edematous and inflamed sinusoids, with numerous proinflammatory cytokines on their surface, requiring a multi-target therapeutic approach. In the absence of any effective treatment, we assessed a newly conceived osmotically active, hypertonic, filmogen solution (Pileseptine-e) directed at attracting hypotonic liquid and helping suppress inflammation. The clinical efficacy and safety of Pileseptine-e on external hemorrhoids was evaluated in this study.Methods: A 2-week treatment + 1-week follow-up, comparative, randomized, double blind, clinical trial with Pileseptine-e (n=37, test product) versus saline spray (n=17, placebo) was performed in patients suffering from external hemorrhoids. Test and placebo products were applied as 3-4 sprays, 3-4 times per day, for 14 consecutive days. Parameters were evaluated employing a 0-4 or 0-10 scoring scale, before treatment (baseline, T0), 2h after 1st treatment, and on Days 2, 3, 8, and 14, with follow-up check on Day 21.Results: The test product induced an instant and strong outward exudation of liquid from inside the edematous hemorrhoids, thereby cleaning their surface, keeping it hydrated, and reducing pain and itching. A strong reduction in the size of hemorrhoids and rectal bleeding was also observed, which improved the quality of life of the patients considerably. The placebo product also provided noticeable symptomatic relief, but without effect on the size of hemorrhoids. No adverse effects were observed in any patient.Conclusion: Reducing edema to allow hemorrhoidal volume to regress, and to normalize the structural physiology of the anal area, is the primary prerequisite to treat external hemorrhoids. Pileseptine-e is an antiedematous, cleaning, hydrating, safe and non-irritant filmogen solution that represents great advancement in the treatment of external hemorrhoids.

Clinical Efficacy of a New Generation of Multi-Target, Anti-Edematous, Anti-Inflammatory, Tissue Repairing Topical Polymeric Liquid Bandage for the Treatment of Internal Hemorrhoids

Objective: Internal hemorrhoids are a widespread vascular disease for which currently there is no satisfactory curative treatment available. The pathology involves the disintegration of the supporting tissue of the anal cushions, causing venous dilation, blood stagnation in the hemorrhoid, formation of edematous venous plexus covered by mucosa, and inflammation. An effective treatment must therefore be multi-target and capable of acting on all the pathology parameters simultaneously. We evaluated the clinical efficacy of a topical, osmotically active filmogen medical device (VB-Gy-ip) directed at minimizing edema, inflammation and volume of the lesions, concomitantly. Methods: The study was a multi-centric, randomized, placebo-controlled, double-blind trial on patients suffering from internal hemorrhoids. 1 to 2 ml of test product, presented as a viscous solution containing VB-Gy-ip, presented in 50 ml tubes, was applied manually into the rectum, 3 to 4 times per day, for 14 consecutive days. Xanthan gum solution was used, in identical manner, as placebo or comparator product. The effects on the hemorrhoidal size, pain intensity, rectal bleeding, prolapse, defecation discomfort, irritation and itching were quantified using a 0 (no symptoms) to 10 (severe symptoms) scoring scale. Study design included 36 test product patients versus 18 placebo patients. Product safety and acceptability were also evaluated. All patients were re-examined on Day 21 to assess the eventual reversibility of the effects observed. Results: Although regular and frequent use of xanthan gum gel helped reduce internal hemorrhoid symptoms appreciably, the test product remarkably induced very fast and statistically significant regression of all the clinical signs without any side effects. Conclusion: An ideal treatment for internal hemorrhoid should simultaneously reduce edema, pain, inflammation, and the size of the lesion without any irritation or side effects. VB-Gy-ip is a completely new class of multi-target treatment for internal hemorrhoids, representing a big hope for millions of patients suffering from this pathology.

A New Generation of Throat Cleaning and Healing Filmogen Solution forthe Treatment of Productive (Wet) Cough

Objective: Wet cough is one of the most common pathologies in the world affecting nearly 12% of the world population. Being a multifactorial disease, involving initially viral infection, followed by bacterial secondary superinfection, damage to the throat mucosa, production of sticky mucus, and poor local immunity, there is currently no effective drug available. We conceived VB-Gy, an osmotically active filmogen solution, capable of cleaning the infected surface of all contaminants topically present, and of preparing a favorable ground for healing. The efficacy and safety of VB-Gy is assessed through a clinical trial, vs. saline solution as comparator product. Methods: The study was a multi-centric, randomized, placebo-controlled, double-blind trial on patients suffering from wet cough. The study involved 39 in the test product group and 15 patients in the comparator group, each patient applying 3-4 sprays of investigational product 4-5 times per day, over a maximum period of 15 days. The effects on wet cough severity, frequency, chest discomfort, as well as on throat pain, irritation, requirement for antibiotics, and answers to Leicester cough questionnaire for quality of life, were evaluated. Results: Although regular and frequent use of saline solution spray helped reduce wet cough symptoms noticeably, the test product induced very fast and nearly total regression of all clinical signs without any side effects, with statistically highly significant difference compared to placebo comparator and baseline data. Conclusion: Treating wet cough requires a multi-target, cell-friendly, and safe approach to obtain not only symptomatic but also curative relief. VB-Gy is a completely new generation of nearly instant, safe, and multi-target therapeutic approach of treating various topical infections.

A New Class of Polymeric Anti-Allergen Nasal Barrier Film Solution forthe Treatment of Allergic Rhinitis

Objective: Allergic rhinitis (AR) is oversensitivity of nasal mucosa to allergen exposure leading to IgE-mediated nasal mucosal inflammation and cellular destruction. Applying any chemical drug over the nasal mucosa may provide symptomatic relief but at the same time the presence of chemicals, such as cortisones and antihistaminic, hampers mucosa repair and, in consequence, cellular defense functions. Therefore, cleaning, avoiding allergen exposure, and protecting nasal mucosa from contact with allergens with a cell-friendly mechanical device, could be an effective remedy to treat allergic rhinitis. Methods: A double blind, randomized, placebo controlled, multicenter clinical trial was conducted in patients suffering from severe AR. 15 patients were treated with saline as comparator product (CP) versus 31 treated with the test product (TP). The test product contained a natural gum-glycerol solution (VB-Gy) which was rendered filmogen using inert natural polymers (Allercyanidin-H) and termed as VB-Gy-Allercyanidin-H formula. The products (15 ml sprays) were applied topically over the nasal mucosa, 3-4 times a day over a period of 3 weeks. Total, reflective and instantaneous nasal symptom scores for rhinorrhea, nasal discharge, sneezing, and itching, as well as ocular scores (itching, tearing, redness) and rescue medicine use scores were evaluated daily during weeks -1 to +3 employing a 0 (no symptoms) to 3 (severe symptoms) scoring scale. Rhino-conjunctivitis quality of life (RQLQ) questionnaires were completed at the start and at the end of the study. Saline solution (CP) was used identically to the TP. Mean weekly results in CP and TP groups were compared with the scores at the start of treatment (baseline) and between the two groups. Results: CP was found to reduce only slightly the symptomatic manifestation of allergic rhinitis. The mean reduction compared to baseline at the end of weeks 1, 2, and 3 was respectively 11.7%, 13.6% and 15.1% for total nasal symptom scores (rTNSS); 9.9%, 14.5%, and 15.8% for total ocular symptom scores (rTOSS); and 4.97%, 8.45%, and 10.94% for pre-dose instantaneous total ocular symptom scores (am-iTOSS, p: Not Significant: NS). During the same period, compared to CP scores, the reduction in TP group was higher by 37.7%, 58.4%, and 73.5% for rTNSS; 38.3%, 54.6%, and 64.1% for rTOSS and 29.84%, 48.91%, and 59.77% for am-iTOSS (p<0.05 for all parameters vs. CP at the same time points). The rhinoconjunctivitis quality of life questionnaire (RQLQ), measured using standard established questionnaire, was improved by 50.28% in TP group compared to 22.85% in CP group. During the study period, at least one rescue medicine was used by 80% patients in CP group compared to only 29% in TP group. Both products were well tolerated and induced no undesired effects. Conclusion: In the absence of any cell-friendly, safe, and multi-target treatment for allergic rhinitis, using a mechanically acting, filmogen barrier solution capable of blocking new allergen contact and minimizing the concentration of immune cells on the nasal surface represents a simple but highly effective approach for the treatment of common allergic rhinitis.