Irritation and Anal Bleeding in Patients Affected by Hemorrhoids.
Kata kunci
Abstrak
Deskripsi
Haemorrhoidal disease is an increasingly frequent benign condition, able to negatively affect the quality of working and relationship life in affected individuals.The primary objective of the study is the comparative assessment of the time necessary for the disappearance of bleeding comparatively in the three different therapies (controls, ProtFlav and ProtCent) to identify, if any, the most effective treatment, in terms of time reduction for the disappearance of bleeding in subjects affected by haemorrhoidal disease.
Secondary objectives are the evaluation of the longitudinal trend in time of anal irritation measured with the VAS scale and the study of the longitudinal performance of BMI (Body Mass Index).
The patients enrolled in the protocol will be randomized into 3 groups: the control group in which the patients will be subjected to a diet rich in water and vegetable fibers, hygienic care and anal dilator according to the traditional standardized scheme. The two experimental groups will be subjected to the same standard therapeutic scheme (diet rich in water and vegetable fibers, hygienic) of the controls, in addition to which will be added to oral supplements (group "ProtFlav") and local application as an anal cream (group "ProtCent"). Of the patients in the interventional groups, half will take flavonoid-based supplements (ProtFlav) and the other half will take supplements and anal cream based on Centella asiatica (ProtCent), as better specified below. All patients will be followed for a period of 8 weeks or otherwise until recovery (disappearance of irritation and stop bleeding).
tanggal
| Terakhir Diverifikasi: | 04/30/2018 |
| Pertama Dikirim: | 05/07/2018 |
| Perkiraan Pendaftaran Telah Dikirim: | 06/22/2018 |
| Pertama Diposting: | 06/25/2018 |
| Pembaruan Terakhir Dikirim: | 07/10/2018 |
| Pembaruan Terakhir Diposting: | 07/12/2018 |
| Tanggal Mulai Studi Sebenarnya: | 04/30/2018 |
| Perkiraan Tanggal Penyelesaian Utama: | 11/30/2018 |
| Perkiraan Tanggal Penyelesaian Studi: | 04/30/2019 |
Kondisi atau penyakit
Intervensi / pengobatan
Drug: ProtFlav
Drug: ProtCent
Behavioral: Standard
Tahap
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| Experimental: Standard standard of care (diet rich in water and vegetable fibers, hygienic) | Behavioral: Standard diet rich in water and vegetable fibers, hygienic and anal dilator |
| Experimental: ProtFlav oral supplements (flavonoid-based supplements - ProtFlav) will be added to standard of care | Drug: ProtFlav Ingredients: soybean oil (glycine max), edible gelatin, rutin, borage seed oil (borago officinalis), pineapple dry extract (ananas sativus), glycerol, thickeners (mono and diglycerides of fatty acids), emulsifier (soy lecithin). |
| Experimental: ProtCent anal application of a Centella based cream (Centella asiatica - ProtCent) will be added to standard of care | Drug: ProtCent The components are: Centella Asiatica, Beta-glucan, Arnica, Aloe Vera, Menthol, Devil's claw, perform actions useful to alleviate the painful symptomatology, restore the tone of the venous wall, assist the treatment of microcirculatory damage. |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | Inclusion Criteria: - Male and female affected by acute haemorrhoidal disease - Collaborating patients, able to understand Exclusion Criteria: - Women who are pregnant or have been breastfeeding; - Previous colorectal surgery; - Anal stenosis; - Treatment (topical or systemic) with decongestants, diuretics, steroidal anti-inflammatory drugs or NSAIDs, antipyretics, antibiotics or antivirals for other reasons; - Psychiatric and / or toxic employees; - Age in completed years, less than 18 and over 85; - If the patient's personal clinical record does not have at least two controls, it is excluded from the clinical study; - Refusal to participate in the study. |
Hasil
Ukuran Hasil Utama
1. delta of time necessary for the disappearance of bleeding [3 months]
Ukuran Hasil Sekunder
1. delta of Visual Analog Scale for Pain (VAS Pain) [3 months]
2. delta of BMI (Body Mass Index). [3 months]
