Colon CancerABSNCT05438771
The Effects of Ankaferd Blood Stopper
A study testing Ankaferd Blood Stopper and Bicarbonate in people with Colon Cancer and Oral Mucositis, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, Oral Mucositis, Nurse's Role
- What is being tested?
- Ankaferd Blood Stopper and Bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18-75
- At least primary school graduate
- No communication problems
- No mouth sores/mucositis (Mucositis stage=0)
- Having been diagnosed with colorectal cancer
- To receive Folfox (5-Fluorouracil, oxalplatin, folinic acid) combination therapy as first-line therapy Not having received chemotherapy or radiotherapy with any other diagnosis before
- Agreeing to participate in the study
- ECOG performance status 0-2
Who cannot join
- Don't be a denture
- Having an oral herpes simplex lesion
- Smoking
- Using Glutemine Research
- Receiving G-CSF support
- Having a physical disability that prevents them from using the right brushing technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy
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.
Read the 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
- Colon Cancer, Oral Mucositis, Nurse's Role, Chemotherapy Effect
- Being tested
- Ankaferd Blood Stopper, Bicarbonate
- Keywords
- Colorectal cancer,, Oral Mukozit, Ankaferd Blood Stopper
- Medical subject headings
- Colonic Neoplasms, Stomatitis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankaferd Blood StopperCombination product
Also called brushing teeth
mouth wash
BicarbonateOther
Also called brushing teeth
mouth wash
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonate | Active comparator | 1.Correct method of brush Platelet value suitable for tooth brushing Feature of toothbrush (soft, nylon bristled, rounded tip, standard size) Fluoride toothpaste, its amount and use in dry brushes In toothbrush 45 degree, the contact of the bristles with the gums, 4 times contact with the inner, outer, chewing surface, tongue cleaning The benefits of correct brushing (preventing dental plaque and gingival recession, etc.) Importance of brushing teeth twice a day (breakfast and after dinner) Preparation of mouth wash Boiled and cooled water at 100°C Putting 5 measures of boiled and cooled water in a teacup with the 20 ml measuring cup provided.
Adding 1 teaspoon (6 g) of sodium bicarbonate to water Making a mouthwash Teaching how to gargle with 20 ml of bicarbonate 4 times a day at 6-hour intervals and being asked to spit it out without swallowing, Receives: Other: Bicarbonate |
| Ankaferd Blood Stopper | Experimental | Correct method of brush Preparation of the mouthwash Boiled and cooled water at 100°C Putting 4 ml of water in the 5 ml measuring cup given to the patient Putting Ankaferd Blood Stopper on the remaining 1 ml portion of the 5 ml beaker Giving information about making and using mouthwash Use on an empty stomach 2 hours before meals in the morning and at least 2 hours after dinner After rinsing your mouth thoroughly with a mouthwash containing 5 ml of Ankaferd Blood Stopper prepared 2 times a day, you can swallow the solution in your mouth.
It is said that there is a solution-related discoloration in the mouth and teeth, but that it will return to its original state after tooth brushing. Receives: Combination Product: Ankaferd Blood Stopper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form, which was created as a result of literature review by the researchers at the beginning of the study, was prepared for both the study and control group patients included in the sample. It consists of 12 questions including brushing habits and the person responsible for its care) and health status and habits (having another chronic disease, smoking and alcohol use).
Measured: day 1
ECOG Performance Score (Eastern Cooperative Oncology Group)
The Eastern Cooperative Oncology Group (ECOG) performance scale, also known as the WHO or Zubrod performance score, was developed in 1960. On the ECOG Performance scale, 0 means normal health and 5 means death. Low scores indicate good general condition, while high scores indicate poor prognosis. '0' Normal. Can maintain normal activity before the disease, '1' Can continue his daily life with bearable tumor findings, '2', Has disturbing tumor findings but spends more than 50% of his time out of bed, '3' Is severely disturbed and spends % of his time It is evaluated as '4' Being in a very uncomfortable condition and spending all his time tied to the bed, '5' Dead, who had to stay more than 50 of them tied to the bed.
Measured: Up to Day 15
Oral Care Control Chart
This form was developed by the researchers in order to ensure that patients' oral care intervals, tooth brushing and mouthwash are made and to prevent them from being forgotten. It was used to record the oral care performed by the patients in the intervention and control groups during the follow-up period. The form is a checklist to be filled by clicking after oral care.
Measured: Up to Day 15
Secondary outcomes (1)
Number of participants with abnormal laboratory test results
hemoglobin, hematocrit, neutrofil, body mass index
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jun 2021
- Primary completion2 Jun 2023 (estimated)
- Study completion2 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a randomized controlled experimental study on patients newly diagnosed with colorectal cancer who would receive the first course of FOLFOX combination chemotherapy.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Karacan, Uludag University
- Investigators
- Hicran Yıldız, Study director, Hicran Yıldız
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438771
- Sponsor's protocol ID
- Bursa Uludag University
- Acronym
- ABS
- Status last verified
- May 2023
- First submitted
- 9 Aug 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share after the work is done
Publications
Elad S. The MASCC/ISOO Mucositis Guidelines 2019 Update: introduction to the first set of articles. Support Care Cancer. 2019 Oct;27(10):3929-3931. doi: 10.1007/s00520-019-04895-x. Epub 2019 Jul 8. No abstract available.
PubMed 31286226Djuric M, Hillier-Kolarov V, Belic A, Jankovic L. Mucositis prevention by improved dental care in acute leukemia patients. Support Care Cancer. 2006 Feb;14(2):137-46. doi: 10.1007/s00520-005-0867-7. Epub 2005 Jul 22.
PubMed 16041502Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
PubMed 31631858Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
PubMed 18304416Orhan I, Dogan R, Soylu E, Aksoy F, Veyseller B, Ozturan O, Esrefoglu M, Aydin MS. Histopathological evaluation of Ankaferd blood stopper use in the rabbit septoplasty model. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):305-9. doi: 10.1016/j.ijporl.2014.11.015. Epub 2014 Dec 15.
PubMed 25596649Saito H, Watanabe Y, Sato K, Ikawa H, Yoshida Y, Katakura A, Takayama S, Sato M. Effects of professional oral health care on reducing the risk of chemotherapy-induced oral mucositis. Support Care Cancer. 2014 Nov;22(11):2935-40. doi: 10.1007/s00520-014-2282-4. Epub 2014 May 23.
PubMed 24854326Sonis ST. Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomatotoxicity. Oral Oncol. 1998 Jan;34(1):39-43. doi: 10.1016/s1368-8375(97)00053-5.
PubMed 9659518Karacan Y, Yildiz H, Evrensel T, Haznedaroglu IC. The effects of Ankaferd hemostat on preventing oral mucositis in colorectal cancer patients receiving chemotherapy. Support Care Cancer. 2023 Jun 8;31(7):385. doi: 10.1007/s00520-023-07856-7.
PubMed 37289263
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05438771
- Acronym / sponsor ID
- ABS / Bursa Uludag University
- Conditions
- Colon Cancer, Oral Mucositis, Nurse's Role, Chemotherapy Effect
- Keywords
- Colorectal cancer,, Oral Mukozit, Ankaferd Blood Stopper
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 2 Jun 2023 (estimated)
- Study completion
- 2 Jun 2023 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was designed as a randomized controlled experimental study on patients newly diagnosed with colorectal cancer who would receive the first course of FOLFOX combination chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate | Active comparator | Other: Bicarbonate1.Correct method of brush Platelet value suitable for tooth brushing Feature of toothbrush (soft, nylon bristled, rounded tip, standard size) Fluoride toothpaste, its amount and use in dry brushes In toothbrush 45 degree, the contact of the bristles with the gums, 4 times contact with the inner, outer, chewing surface, tongue cleaning The benefits of correct brushing (preventing dental plaque and gingival recession, etc.) Importance of brushing teeth twice a day (breakfast and after dinner) Preparation of mouth wash Boiled and cooled water at 100°C Putting 5 measures of boiled and cooled water in a teacup with the 20 ml measuring cup provided. Adding 1 teaspoon (6 g) of sodium bicarbonate to water Making a mouthwash Teaching how to gargle with 20 ml of bicarbonate 4 times a day at 6-hour intervals and being asked to spit it out without swallowing, |
| Ankaferd Blood Stopper | Experimental | Combination Product: Ankaferd Blood StopperCorrect method of brush Preparation of the mouthwash Boiled and cooled water at 100°C Putting 4 ml of water in the 5 ml measuring cup given to the patient Putting Ankaferd Blood Stopper on the remaining 1 ml portion of the 5 ml beaker Giving information about making and using mouthwash Use on an empty stomach 2 hours before meals in the morning and at least 2 hours after dinner After rinsing your mouth thoroughly with a mouthwash containing 5 ml of Ankaferd Blood Stopper prepared 2 times a day, you can swallow the solution in your mouth. It is said that there is a solution-related discoloration in the mouth and teeth, but that it will return to its original state after tooth brushing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- between the ages of 18-75
- At least primary school graduate
- No communication problems
- No mouth sores/mucositis (Mucositis stage=0)
- Having been diagnosed with colorectal cancer
Key exclusion criteria (6 listed)
- Don't be a denture
- Having an oral herpes simplex lesion
- Smoking
- Using Glutemine Research
- Receiving G-CSF support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankaferd Blood StopperAlso: brushing teethmouth wash | Combination product | Ankaferd Blood Stopper |
| BicarbonateAlso: brushing teethmouth wash | Other | Bicarbonate |
Primary outcome
Personal Information Form
Time frame: day 1
This form, which was created as a result of literature review by the researchers at the beginning of the study, was prepared for both the study and control group patients included in the sample. It consists of 12 questions including brushing habits and the person responsible for its care) and health status and habits (having another chronic disease, smoking and alcohol use).
ECOG Performance Score (Eastern Cooperative Oncology Group)
Time frame: Up to Day 15
The Eastern Cooperative Oncology Group (ECOG) performance scale, also known as the WHO or Zubrod performance score, was developed in 1960. On the ECOG Performance scale, 0 means normal health and 5 means death. Low scores indicate good general condition, while high scores indicate poor prognosis. '0' Normal. Can maintain normal activity before the disease, '1' Can continue his daily life with bearable tumor findings, '2', Has disturbing tumor findings but spends more than 50% of his time out of bed, '3' Is severely disturbed and spends % of his time It is evaluated as '4' Being in a very uncomfortable condition and spending all his time tied to the bed, '5' Dead, who had to stay more than 50 of them tied to the bed.
Oral Care Control Chart
Time frame: Up to Day 15
This form was developed by the researchers in order to ensure that patients' oral care intervals, tooth brushing and mouthwash are made and to prevent them from being forgotten. It was used to record the oral care performed by the patients in the intervention and control groups during the follow-up period. The form is a checklist to be filled by clicking after oral care.
1 secondary outcome
Number of participants with abnormal laboratory test results
Time frame: Up to Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 31286226Elad S. The MASCC/ISOO Mucositis Guidelines 2019 Update: introduction to the first set of articles. Support Care Cancer. 2019 Oct;27(10):3929-3931. doi: 10.1007/s00520-019-04895-x. Epub 2019 Jul 8. No abstract available.
- Results publication: PubMed 16041502Djuric M, Hillier-Kolarov V, Belic A, Jankovic L. Mucositis prevention by improved dental care in acute leukemia patients. Support Care Cancer. 2006 Feb;14(2):137-46. doi: 10.1007/s00520-005-0867-7. Epub 2005 Jul 22.
- Results publication: PubMed 31631858Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
- Results publication: PubMed 18304416Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
- Results publication: PubMed 25596649Orhan I, Dogan R, Soylu E, Aksoy F, Veyseller B, Ozturan O, Esrefoglu M, Aydin MS. Histopathological evaluation of Ankaferd blood stopper use in the rabbit septoplasty model. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):305-9. doi: 10.1016/j.ijporl.2014.11.015. Epub 2014 Dec 15.
- Results publication: PubMed 24854326Saito H, Watanabe Y, Sato K, Ikawa H, Yoshida Y, Katakura A, Takayama S, Sato M. Effects of professional oral health care on reducing the risk of chemotherapy-induced oral mucositis. Support Care Cancer. 2014 Nov;22(11):2935-40. doi: 10.1007/s00520-014-2282-4. Epub 2014 May 23.
- Results publication: PubMed 9659518Sonis ST. Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomatotoxicity. Oral Oncol. 1998 Jan;34(1):39-43. doi: 10.1016/s1368-8375(97)00053-5.
- Derived from this study: PubMed 37289263Karacan Y, Yildiz H, Evrensel T, Haznedaroglu IC. The effects of Ankaferd hemostat on preventing oral mucositis in colorectal cancer patients receiving chemotherapy. Support Care Cancer. 2023 Jun 8;31(7):385. doi: 10.1007/s00520-023-07856-7.
- Individual participant dataSharing planned: No. I can share after the work is done
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicran Yıldız study director
Hicran Yıldız
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankaferd Blood Stopper and Bicarbonate in people with Colon Cancer and Oral Mucositis, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438771, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.