Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.
To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varicell | Experimental | Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days. |
|
| Placebo daflon (Drug D) | Experimental | Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daflon | Drug | Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. | Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. | Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon. | 30 days |
Not provided
Inclusion Criteria:
For Group V - Chronic Venous Insufficiency.
In Group H - hemorrhoidal syndrome.
Exclusion Criteria:
Pregnant or lactating;
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Calil, Investigator | Contact | 55 11 5549-6488 | mcburihan@osite.com.br | |
| Mônica Gonçalves, Coordenator | Contact | 55 11 2070-6238 | monica_monica0001@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jacques Waisberg, Investigator | ABC School of Medicine | Principal Investigator |
| Walter Campos Júnior, Investigator | Edmundo Vasconcelos Hospital Teacher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Marcelina Hospital | São Paulo | São Paulo | 05016-081 | Brazil |
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004145 | Diosmin |
| D007633 | Keratins |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Varicell placebo | Drug | Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days. |
|
|
| Laércio Robles, Investigator |
| Santa Marcelina Hospital |
| Principal Investigator |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007381 | Intermediate Filament Proteins |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012596 | Scleroproteins |