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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viusid® + Glizigen® | Experimental | The experimental arm will receive nutritional supplements Viusid + Glizigen |
|
| Placebo | Placebo Comparator | The control group will receive a placebo of both (Viusid and Glizigen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Institute | Vedado | La Habana | 10600 | Cuba |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C551853 | Viusid |
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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.
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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.
|
| 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 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 . |
|
| 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. |
|
| 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 |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |