Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal
Condition: Papilloma Viral Infection; Papillomavirus Infections; Esophageal Viral Wart; Esophageal Verrucous Carcinoma
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Papillomavirus Infections; Carcinoma, Verrucous; Papilloma
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): Viusid®; Glizigen®; Viusid Placebo; Glizigen Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.; 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 .; The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary purpose: Treatment
Keywords: Papillomavirus; Viusid; Glizigen; Papilloma virus Esophageal; Antioxidant