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 reexamined 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.

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Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p<0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.