Clinical study

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Clinical research/Clinical trials conducted by Dunărea de Jos University Galati Faculty of Medicine in collaboration with Irina Medical Centre


The conclusions:

It is a safe product, easy to administer and well tolerated by patients. It does not present any side effects or categorical contraindications. Its effectiveness is proven for all hemorrhoidal diseases.

97% of the patients showed positive results

Summary of the research-development of the HemoTreat H product

The professors and doctors that worked on the research study concluded that a surgical procedure in case of hemorrhoidal disease must be the last solution.

The study provides important medical findings on the applicability of the product.
Irina Medical Centre is the facility in which the diagnoses were made based on imaging and para-clinical investigation, and treatments and post therapeutic follow-up were conducted.

The project was divided into two stages:

La prima fase della progettazione di nuovi prodotti e di prova, laboratori di prova esequita a la Facoltà di Medicina e Farmacia dell Università del “Basso Danubio” -Galati. In questa fase ѐ stata condotta caratterizzatione biochimica, microbiologica e prodotto funzionale.

The first step included product design and testing which was performed in the laboratories owned by the Faculty of Medicine at the Dunarea de Jos University in Galati. In this stage, it was carried out the biochemical, microbiological and functional characterization of the products.

The second step was the clinical study:

• Selecting the group of patients
• Clinical evaluation of the patients
• Laboratory evaluation of the patients to exclude possible pathologies that may have caused or contributed to hemorrhoidal disease
• The application of the HemoTreat H ointment
• Subjective and objective patient monitoring after the treatment
• Delivering the results

36 patients were analysed, all from urban areas, aged between 20 and 75 years. Their medical histories showed that almost 75% of the patients (27 out of 36) had at least one recurrence of the disease while only 9 patients (25%) were experiencing hemorrhoidal disease for the first time. Three patients experienced disease recurrence even after surgery.

Following the initial clinical examination, it was found that: 52,78% (19 patients) were found with only one hemorrhoidal ulceration, 38.88% (14 patients) were found with two hemorrhoidal ulcerations, 8.34% (3 patients, all with the age over 50 years) presented hemorrhoidal prolapse.

In terms of symptoms, 72,22%(26 patients) experienced anal pain and discomfort, 61,11%(22 patients) accused anal itching, 61,11(22 patients) observed anal bleeding after defecation, 33,33%(12 patients) noticed excessive moisture around the anus area. The laboratory investigations consisted of the following tests: CBC, AST, ALT, GGT, ESR, glucose levels.

To highlight the related pathologies, the patients underwent ultrasound examinations. The patients were submitted to a proctoscopy test before applying the ointment, and then they were examined after 4 and respectively 7 days. The proctoscopy was repeated at the 7 day mark, and a re-evaluation took place after 30 days.

44,44%(16 patients) presented internal hemorrhoids type II and III and external hemorrhoids, and 2,78%(1 patient) also suffered from anal bleeding.

Pre-treatment examination

At the moment of the first examination(including a proctoscopy) before the treatment, the patients were classified into the next three groups:

• Grade I internal hemorrhoids: 16,66%(6 patients)

• Grade II internal hemorrhoids: 72,22%(26 patients)

• Grade III internal hemorrhoids: 11,12%(4 patients)

Clinical examination at 4, 7 and 30 days

Based on the data collected through clinical examination and anamnesis at 4 and 7 days and the clinical examination and proctoscopy at 30 days, the following outcomes were observed:

• Pain relief: 88,46%(23 of the 26 that initially experienced pain)

• Reduced itching: 72,22%(16 of the 22 that initially experienced prurience)

• Decreased swelling: 88,88%(8 of the 9 that initially experienced swollen tissues)

• Hemostasis: 50%(11 of the 22 that initially experienced bleeding)

Proctoscopy results after 30 days of treatment

After 30, the proctoscopy results showed the following results:

• Grade I internal hemorrhoids: 6 patients initially: 4 experienced complete remission and 2 showed significant improvements

• Grade II internal hemorrhoids: 26 patients initially: 21 patients were reclassified as a grade I after treatment, 5 patients showed improvements

• Grade III internal hemorrhoids: 4 patients initially: 1 patient was reclassified as a grade II after treatment, 3 patients showed no improvements

It was found that 97 %( 35 of the 36 patients) had a positive response to the treatment, while only one patient with grade III internal and external hemorrhoids showed no improvements.

97% of the patients showed positive results

Permanently solve problems

HemoTreat H permanently treats internal and external hemorrhoids, with positive results from day one.

The ointment act on the causes: swollen blood vessels and irritated tissues surrounding the anal area.

Anal fissures, long-term effects

The ointment solves all the problems completely, and maintaining a healthy diet and active lifestyle can mean the permanent disappearance of hemorrhoids from your life.

Anal fissure treatment without any side-effects

Clinical studies have shown no side effects or adverse effects. The ointment has a positive impact on tissues and blood vessels.

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