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Trials / Unknown

UnknownNCT05438771

The Effects of Ankaferd Blood Stopper

The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
Uludag University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of oral care is to reduce the effect of oral pathological microbial flora and to prevent infection, pain, and bleeding associated with cancer treatment. New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd Hemostat. Ankaferd Hemostat has pleiotropic effects and anti-infective characteristics in tissue healing. The aim of this study is to evaluate the effectiveness of the Ankaferd Hemostat in the prevention of oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer. The study was designed as a randomized controlled experimental study to be conducted with patients who are recently diagnosed with colorectal cancer and will receive the first course of chemotherapyd. The data were collected using the Performance Score and the Oral Mucositis Evaluation Scale.

Detailed description

In patients with colorectal cancer, it is important to perform symptom management dynamically as well as specific treatments for cancer. It is extremely important for healthcare professionals to know the approaches that can be recommended to patients in the management of treatment and disease-related symptoms, in order to prevent problems that may develop in patients due to the severity of symptoms. Controlling the symptoms will increase the patient's functional capacity and quality of life. Oral mucositis is one of the common toxic effects of chemotherapy. Pain due to mucositis causes anorexia-dysphagia development and malnutrition. As a result, systemic infections can develop, dose reduction in chemotherapy courses, increase in cost and prolongation of hospital stay. Looking at the literature, chloroxidine, glutamine, palifermin was used to prevent the development of mucositis during 5-Fu-based therapy for colon cancer. Solutions such as bicarbonate were used. Although it was determined in these studies to prevent the development of oral mucositis, the incidence of mucositis is still high. Therefore, the search for new treatments and applications to prevent mucositis continues. Ankaferd Hemostat is a herbal product used as a hemostatic agent in traditional Turkish medicine. Ankaferd Hemostat affects endothelium, blood cells, angiogenesis, cellular reproduction and vascular dynamics and stimulates mediators that lead to rapidly progressive wound healing. In addition to these, the anti-inflammatory, antimicrobial, antifungal and antioxidative effects of Ankaferd Hemostat are mentioned in the literature. In order to determine the effectiveness of Ankaferd Hemostat application in chemotherapy-induced oral mucositis in adult patients, there is a single study conducted on 20 patients with mucositis grade 2-3 with hematological malignancy. While it is stated in the literature that the healing time of mucositis is the week after 7-14 days, it was seen that this decreased to 6.6 (3-10) days in the study conducted by Atay. In another study conducted in the field of dentistry, the effectiveness of Ankaferd Hemostat in preventing the development of oroantral fistula was evaluated. In a study comparing the use of Platelet Rich Plasma (PRP) in one arm and Ankaferd Hemostat in the other arm, it was found that the antibacterial effect was more prominent in the Ankaferd Hemostat arm and the results of edema, bleeding and infection were similar in both arms .

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTAnkaferd Blood Stoppermouth wash
OTHERBicarbonatemouth wash

Timeline

Start date
2021-06-01
Primary completion
2023-06-02
Completion
2023-06-02
First posted
2022-06-30
Last updated
2023-06-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05438771. Inclusion in this directory is not an endorsement.