Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease

NCT ID: NCT03545724

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2019-05-16

Brief Summary

Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.

Detailed Description

Evaluation of the effect and safety of NeoFitoroid® in relieving discomfort symptom after 10 days of treatment compared to baseline (pretreatment).

The study duration per patient is 31 days (visit 1 + 10 days treatment + 20 days follow-up).

Conditions

Hemorrhoids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neofitoroid®

Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.

Group Type: EXPERIMENTAL

Neofitoroid®

Intervention Type: DEVICE

NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.

Interventions

Neofitoroid®

NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.

Intervention Type: DEVICE

Other Intervention Names

Rescue therapy

Eligibility Criteria

Inclusion Criteria

1. Patients of both sexes ≥ 18 years .

2. Diagnosis of hemorrhoidal disease of grade I or II, non thrombosed, according to Goligher's classification performed by anoscopy/rectoscopy at screening.

3. Patient is not expected to require non-pharmacological (as Sclerotherapy, Rubber band ligation, Infrared Coagulation, Radiofrequency Ablation, Cryotherapy) or surgical treatment in the 31 days post enrollment .

4. Discomfort score related to the hemorrhoidal disease ≥ 30 measured through a 0-100 Visual Analog Scale VAS (from "no symptoms" to "overwhelming symptoms") at screening.

5. Women of childbearing potential undergone a negative pregnancy test.

6. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.

Exclusion Criteria

1. Patients with gastrointestinal disease like inflammatory bowel disease, celiac disease, colo-rectal cancer, perianal/fistulizing disease).

2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and/or that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

3. Patients with active cancer.

4. Tubercolosis , mycosis, Herpes Symplex, virologic disease with anal or perianal skin localization.

5. Presence of physical and/or mental disability that reduces the ability to take medicines as expected.

6. Concomitant abuse of drugs or alcohol.

7. No adequate reliability or presence of conditions that may result in non-compliance / adherence of the patient to the Protocol.

8. Subjects with known or suspected allergy to plants of Helichrysum family, aloe vera, Ruscus, Hypericum, Jojoba Oil, Shea Butter, Essential oils of: Melaleuca, Cypress and Peppermint.

9. Subjects with known or suspected allergy to ingredients such as: glicerilstearato, Caprylic / capric, sucrose distearate, sucrose stearate, cetearyl alcohol, vegetable glycerin, triidrossistearina, vegetable oils, hydrogenated vegetable oils, Candelilla wax, xanthan gum, citric acid, tocopherols, sodium silicate, benzyl alcohol, potassium sorbate, sodium dehydroacetate, Sunflower oil.

10. Subjects with the presence of alarm symptoms (weight loss, lack of appetite).

11. Prior use of other topical ointment for the treatment of haemorrhoid within 14 days before enrollment.

12. Pregnant and/or breastfeeding patients.

13. Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GB Pharma Group

UNKNOWN

Sponsor Role: collaborator

Aboca Spa Societa' Agricola

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Patologie del Tratto Alimentare, S. Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Other Identifiers

ABO-NFT-17

Identifier Type: -

Identifier Source: org_study_id