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

NCT03584308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-05-22

No results posted yet for this study

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.

Conditions

  • Papilloma Viral Infection
  • Papillomavirus Infections
  • Esophageal Viral Wart
  • Esophageal Verrucous Carcinoma

Interventions

DIETARY_SUPPLEMENT

Viusid®

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.

DIETARY_SUPPLEMENT

Glizigen®

The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.

DIETARY_SUPPLEMENT

Viusid Placebo

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 .

DIETARY_SUPPLEMENT

Glizigen Placebo

The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2018-05-15
Completion
2018-12-15

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584308 on ClinicalTrials.gov