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

NCT03584308 | Completed Phase 2 DMC

• 1 other identifier: VIUSID-GLIZ-PAPILOMA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Papillomavirus; Viusid; Glizigen; Papilloma virus Esophageal; Antioxidant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Evaluation of esophageal pathology

  3 months

• Evaluation of esophageal pathology

  3 months

• Evaluation of esophageal pathology

  3 months

• Evaluation of esophageal pathology

  3 months

• Evaluation of esophageal pathology

  3 months

Study Arms (2)

Viusid® + Glizigen®

EXPERIMENTAL

The experimental arm will receive nutritional supplements Viusid + Glizigen

Dietary Supplement: Viusid®; Dietary Supplement: Glizigen®

Placebo

PLACEBO COMPARATOR

The control group will receive a placebo of both (Viusid and Glizigen).

Dietary Supplement: Viusid Placebo; Dietary Supplement: Glizigen Placebo

Interventions

Viusid® DIETARY_SUPPLEMENT

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.

Viusid® + Glizigen®

Glizigen® DIETARY_SUPPLEMENT

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

Viusid® + Glizigen®

Viusid Placebo DIETARY_SUPPLEMENT

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 .

Placebo

Glizigen Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Gastroenterology Institute

Vedado, La Habana, 10600, Cuba

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Viusid

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double blind. To achieve the masking of the research product, these have been labeled by a computerized randomized balanced list, which will be in the possession of the promoter and the study Biostatistician. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 12, 2018
• Study Start: October 15, 2015
• Primary Completion: May 15, 2018
• Study Completion: December 15, 2018
• Last Updated: May 22, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)