Hematologic DiseasesNCT05982262
Naturopathic-pharmacological Consultation in Hematology
A study testing Naturopathic-pharmacological consultation in people with Hematologic Diseases, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The goal of this cross-sectional study is to learn about the effect of a naturopathic-pharmacologic consultation in patients with hematologic conditions. The main question it aims to answer is whether such consultation can improve the safety of dietary and herbal supplements' use among these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Naturopathic-pharmacological consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2023to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Followed up for a hematological condition
- Ability to fill simple questionnaires in Hebrew, Russian or Arabic
- Indication for consultation:
- Patient's request to expand knowledge about the use of DHS
- Patient using DHS
- Patient's desire to start using DHS
- Patient that is interested in hearing about the use of DHS for his/her health condition
- Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
The goal of this cross-sectional study is to learn about the effect of a naturopathic-pharmacologic consultation in patients with hematologic conditions. The main question it aims to answer is whether such consultation can improve the safety of dietary and herbal supplements' use among these patients.
Participants will be asked to answer basic questions and fill-out questionnaire before and after meeting the consultation team. Some patients will be prescribed dietary and herbal supplements that may help relief some of the symptoms they describe, in a safe way and without interacting with the drugs they are taking.
- Conditions
- Hematologic Diseases
- Being tested
- Naturopathic-pharmacological consultation
- Keywords
- Dietary supplements, Herbal supplements, Hematology, Safety, Consultation, Naturopath, Clinical pharmacist
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturopathic-pharmacological consultationOther
The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematological conditions | Experimental | Patients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria Receives: Other: Naturopathic-pharmacological consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the use of DHS in patients with a hematological disease through naturopathic counseling
Number of potential interactions with moderate to major level of significance prevented by the naturopathic consultation in each patient, as well as the incidence of DHS-related safety events. The Naranjo and modified Food and Drug Administration algorithm will be used to assess the causality of such events with the specific dietary supplements, and only side effects at least possibly caused by the DHS according to these scales will be considered.
Measured: From enrollment to the end of intervention, up to 1 year
Secondary outcomes (5)
Efficacy of prescribed dietary and herbal supplements (DHS)
Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing.
Measured: From enrollment to the end of intervention, up to 1 year
Patient-physician communication around the use of DHS
Asking the patient whether the topic has been brought up with the treating hematologist and checking the documentation of the use of DHS in the medical charts
Measured: From enrollment to the end of intervention, up to 1 year
Patient satisfaction
Direct question asked after each meeting ranking in a 1-5 Likert scale the satisfaction of the patient from the consultation: from 1 (not satisfied at all) to 5 (maximal satisfaction)
Measured: From enrollment to the end of intervention, up to 1 year
Compliance with hematological treatment
Relative dose intensity (RDI) of the prescribed hematological drugs both before and after intervention: The term of dose intensity (DI) is used to define the drug dose delivered per time unit and is expressed as mg/m2 per week. A delay in the sequence of treatment cycles decreases the DI in the same proportion as a reduction of dose. Average relative DI corresponds to the mean DI of combined agents and is expressed as a fraction of a similar combination selected as a standard
Measured: From enrollment to the end of intervention, up to 1 year
Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling
Semi-structured in-depth interviews will be conducted with patients who are interested in participating in the qualitative arm (10-15 patients) and the staff members involved (medical staff, nursing staff, naturopath, clinical pharmacist). The goal is to describe the process of building the naturopathic-pharmacological consultation and evaluate the satisfaction of the staff and patients
Measured: From enrollment to the end of intervention, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Jun 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilana Levy Yurkovski, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982262
- Sponsor's protocol ID
- 0149-20-BNZ
- Status last verified
- Sep 2024
- First submitted
- 16 Jul 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
- ClinicalTrials.gov ID
- NCT05982262
- Acronym / sponsor ID
- 0149-20-BNZ
- Conditions
- Hematologic Diseases
- Keywords
- Dietary supplements, Herbal supplements, Hematology, Safety, Consultation, Naturopath, Clinical pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Aug 2023 (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 goal of this cross-sectional study is to learn about the effect of a naturopathic-pharmacologic consultation in patients with hematologic conditions. The main question it aims to answer is whether such consultation can improve the safety of dietary and herbal supplements' use among these patients.
Participants will be asked to answer basic questions and fill-out questionnaire before and after meeting the consultation team. Some patients will be prescribed dietary and herbal supplements that may help relief some of the symptoms they describe, in a safe way and without interacting with the drugs they are taking.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hematological conditions | Experimental | Other: Naturopathic-pharmacological consultationPatients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Followed up for a hematological condition
- Ability to fill simple questionnaires in Hebrew, Russian or Arabic
- Indication for consultation:
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Naturopathic-pharmacological consultationThe naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings. | Other | Patients with hematological conditions |
Primary outcome
Safety of the use of DHS in patients with a hematological disease through naturopathic counseling
Time frame: From enrollment to the end of intervention, up to 1 year
Number of potential interactions with moderate to major level of significance prevented by the naturopathic consultation in each patient, as well as the incidence of DHS-related safety events. The Naranjo and modified Food and Drug Administration algorithm will be used to assess the causality of such events with the specific dietary supplements, and only side effects at least possibly caused by the DHS according to these scales will be considered.
5 secondary outcomes
Efficacy of prescribed dietary and herbal supplements (DHS)
Time frame: From enrollment to the end of intervention, up to 1 year
Patient-physician communication around the use of DHS
Time frame: From enrollment to the end of intervention, up to 1 year
Patient satisfaction
Time frame: From enrollment to the end of intervention, up to 1 year
Compliance with hematological treatment
Time frame: From enrollment to the end of intervention, up to 1 year
Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling
Time frame: From enrollment to the end of intervention, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hematologic Diseases
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
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.
Ilana Levy Yurkovski, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naturopathic-pharmacological consultation in people with Hematologic Diseases, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of the use of DHS in patients with a hematological disease through naturopathic counseling (time frame: From enrollment to the end of intervention, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.