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In this study researcher wanted to learn more about the changes of biggest twisted and bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment period with the cream Relief Pro and suppositories Relief Pro. The study collected information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute hemorrhoids | Patients with acute hemorrhoids of 1-2 stage were prescribed Fluocortolone + Lidocaine by a physician. No drug will be provided to Patient by the Investigator, only prescription order, based on International Nonproprietary name (Fluocortolone + Lidocaine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relief Pro cream | Drug | Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of pain (VAS: Visual Analogue Scale) | Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain). | Up to 14 days |
| Severity of bleeding (according to 4-point Likert scale) | 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant). | Up to 14 days |
| Severity of pruritus (according to 4-point Likert scale) | Up to 14 days | |
| Severity of swelling (according to 4-point Likert scale) | Up to 14 days | |
| Severity (amount) of discharge (according to 4-point Likert scale) | Up to 14 days | |
| Severity of sense of discomfort (according to 4-point Likert scale) | Up to 14 days | |
| Overall patient satisfaction with treatment (according to 5-point Likert scale) | Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied). | Up to 14 days |
| Time to onset of analgesic effect after the first use of the drug | Up to 14 days | |
| Duration of analgesic effect after the first use of the drug |
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Inclusion Criteria:
Exclusion Criteria:
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Adult male and female patients with acute hemorrhoids from Russia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Center of Coloproctology | Moscow | 123423 | Russia |
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| Relief Pro rectal suppositories | Drug | Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice |
|
| Up to 14 days |
| Patient's adherence to recommendations of the Investigator by PRO | PRO: Patient Reported Outcome | Up to 14 days |
| Information obtained in the course of questioning about the consumer properties of the study product by PRO | Up to 14 days |
| Severity of hemorrhoids symptoms according to the Sodergren score | Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4. | Up to 14 days |
| Size of the largest hemorrhoid node measured during a routine examination | Up to 14 days |
| Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale) | Up to 14 days |
| Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale) | Up to 14 days |
| Amount of ReliefPro used based on information provided by the patient to the Investigator | Up to 14 days |
| Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3 | Up to 14 days |