- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444515
Prospective AnalysiS of Self medIcation With phytOtherapy in Nephropatic Patients. (PASSION)
We propose the following hypotheses:
- The use of herbal medicine is common among patients with chronic kidney disease in Réunion island.
- This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center.
The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year.
We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hospital promotion
- Phone Number: 0262359000
- Email: promotion.drci@chu-reunion.fr
Study Locations
-
-
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Saint-Denis, France, 97400
- Investigator Coordinator
-
Contact:
- Ludovic DI ASCIA
- Phone Number: 0262359000
- Email: ludovic.diascia@chu-reunion.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Individual:
- Adult
- Resident of Réunion Island and planning to remain on the island for the year following enrollment
- Chronic Kidney Disease Stage 3, 4, or 5, not on dialysis
- Under the care of a nephrologist
- Able to complete a questionnaire
- Registered with social security
Exclusion Criteria:
Individual:
- Kidney transplant recipient
- Adult under guardianship or legal protection
- Pregnant or breastfeeding women, or women planning a pregnancy during the enrollment period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All patient with kidney chronic disease
|
Series of question are about self medication with plants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- 2025/RUN/0033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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