Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal

Study Overview
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Brief Summary
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A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.

Detailed Description
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Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm. However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.

Official Title
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Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial

Conditions
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Papilloma Viral Infection, Papillomavirus Infections, Esophageal Viral Wart, Esophageal Verrucous Carcinoma

Intervention / Treatment
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* Dietary Supplement: Viusid®
* Dietary Supplement: Glizigen®
* Dietary Supplement: Viusid Placebo
* Dietary Supplement: Glizigen Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults between 18 and 65 years of both sexes. Patients residing in the provinces of Havana, Artemisa and Mayabeque. Voluntariness of the patient to participate in the study. Informed and written consent. Women of childbearing age should have negative pregnancy test or use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation. Exclusion Criteria: Pregnancy or breastfeeding. Contraindication to the performance of upper digestive endoscopy. Psychiatric conditions that do not favor the administration of treatment and follow-up. History of hypersensitivity to another similar product. Severe acute allergic states. Patients with concomitant diagnosis of esophageal tumor or other causes of infectious esophagitis. Present an associated chronic illness in the decompensation phase (heart disease, diabetes, hypertension, renal failure, AIDSl). Patients who are receiving another product under investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viusid® + Glizigen®<br>The experimental arm will receive nutritional supplements Viusid + Glizigen | Dietary Supplement: Viusid®<br>* The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.<br>Dietary Supplement: Glizigen®<br>* The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.<br>|
| Placebo Comparator: Placebo<br>The control group will receive a placebo of both (Viusid and Glizigen). | Dietary Supplement: Viusid Placebo<br>* The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .<br>Dietary Supplement: Glizigen Placebo<br>* The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of the lesions of the virus in esophageal mucosal tissue sample | Absence of coilocytes / papilloma in the paraffin sample | 3 months | 
| Clinical negativization of the virus in esophageal mucosal tissue sample | Negativization of the virus in fresh sample of the mucosa in the PCR study | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of esophageal pathology | Acanthosis: Yes or No | 3 months | 
| Evaluation of esophageal pathology | Papillary hyperplasia lamina propria: Yes or no | 3 months | 
| Evaluation of esophageal pathology | Hyperplasia of the basal layer of the epithelium: Yes or No | 3 months | 
| Evaluation of esophageal pathology | Dyskeratosis: Yes or No | 3 months | 
| Evaluation of esophageal pathology | Dysplasia: Yes (Low Degree or High Degree) or No | 3 months | 
| Toxicity due to the Treatment administered | It will be determined through the reporting of adverse events that are presented to the research product | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillomavirus, Viusid, Glizigen, Papilloma virus Esophageal, Antioxidant