NCT05982262

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jun 2023Jun 2028

Study Start

First participant enrolled

June 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 16, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 7, 2024

Status Verified

April 1, 2024

Enrollment Period

4.5 years

First QC Date

July 16, 2023

Last Update Submit

May 5, 2024

Conditions

Hematologic Diseases

Keywords

Dietary supplementsHerbal supplementsHematologySafetyConsultationNaturopathClinical pharmacist

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of intervention, up to 1 year

Secondary Outcomes (5)

  • Efficacy of prescribed dietary and herbal supplements (DHS)

    From enrollment to the end of intervention, up to 1 year

  • Patient-physician communication around the use of DHS

    From enrollment to the end of intervention, up to 1 year

  • Patient satisfaction

    From enrollment to the end of intervention, up to 1 year

  • Compliance with hematological treatment

    From enrollment to the end of intervention, up to 1 year

  • Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling

    From enrollment to the end of intervention, up to 1 year

Study Arms (1)

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

Other: Naturopathic-pharmacological consultation

Interventions

Naturopathic-pharmacological consultationOTHER

The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.

Patients with hematological conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3339419, Israel

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Ilana Levy Yurkovski, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Weizer

CONTACT

972543295952dana.weizer@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2023

First Posted

August 8, 2023

Study Start

June 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 7, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)