Study to Find Out How Symptoms Severity Changes During the Standard Course of Treatment With the Cream Relief Pro and Suppositories Relief Pro (Active Ingredients Are Fluocortolone + Lidocaine) in Patients Suffering From Twisted and Bulging Veins in the Rectal Area (Acute Hemorrhoids)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Acute Hemorrhoids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Relief Pro cream

Intervention Type DRUG

Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.

Relief Pro rectal suppositories

Intervention Type DRUG

Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice

Interventions

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Relief Pro cream

Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.

Intervention Type DRUG

Relief Pro rectal suppositories

Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male \& female patients 18 to 65 years old;
* Patients with acute hemorrhoids 1 and 2 stage (with thrombosis (external, internal, mixed), including cases with bleeding);
* Prescription of fluocortolone + lidocaine as a part of routine clinical practice.

Exclusion Criteria

* Patients participating in an investigational program with interventions outside of routine clinical practice;
* Hemorrhoid with stage ˃ II;
* Contraindications for use of Relief PRO in the approved product label;
* Anemia and/or severe/profuse hemorrhoid bleeding;
* Surgery in perianal region in anamnesis;
* Concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic and/or immunosuppressant;
* Inflammatory bowel disease;
* Hepatic diseases in severe and acute stages;
* Colorectal cancer;
* Purulent-inflammatory diseases of the perianal region and anal canal;
* Chronic pulmonary diseases in severe and acute stages.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No