Clinical trial NCT03545724: Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease
Official title: Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: GB Pharma Group
First posted: 2018-06-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assignment
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 10 vs day 0
Secondary outcomes:
measure: Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).
timeFrame: day 3 and day 7 vs day 0
measure: Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Reduction of bleeding at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Reduction of anal leakage at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present)
timeFrame: day 10 vs day 0
measure: Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).
timeFrame: day 10 vs day 0
Other outcomes:
measure: Assessment on number of defecation at day 0, 3, 7 and 10.
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Assessment on type of defecation at day 0, 3, 7 and 10.
timeFrame: day 3, day 7 and day 10 vs day 0
measure: Assessment of number of relapses between end of treatment and day 31
timeFrame: day 31 vs day 10
measure: Safety and tolerability: analysis of adverse events and serious adverse events
timeFrame: from day -7 to day 31
Locations:
city: Bologna
country: Italy
facility: Patologie del Tratto Alimentare, S. Orsola-Malpighi
Study officials:
References: