Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141200
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-15
Brief Title:
NW Roselle in Grade 1 Essential Hypertension Phase III Clinical Trial
Sponsor:
Natural Wellness Egypt
Organization:
Natural Wellness Egypt
Study Overview
Official Title:
Efficacy and Safety of Roselle in Patients With Grade 1 Essential Hypertension A Phase III Randomized Double-Blind Double-Dummy Active-Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this Phase III clinical trial researchers evaluate the efficacy and safety of NW Roselle a powdered medicinal product developed by Natural Wellness NW Roselle combines extracts from Hibiscus Sabdariffa HS flowers and Olea europaea OE leaves The trial aims to gather evidence on the efficacy and safety of NW Roselle as a potential treatment option for Grade 1 essential hypertension
Detailed Description:
Hypertension is a major risk factor for heart brain and kidney diseases and is a leading cause of death and illness globally Natural Wellness has developed NW Roselle a powdered medicinal product that combines extracts from Hibiscus Sabdariffa HS flowers and Olea europaea OE leaves
In this Phase III clinical trial researchers are evaluating the efficacy and safety of NW Roselle in the treatment of Grade 1 essential hypertension Eligible participants who meet the criteria will be enrolled and randomized in a 11 ratio They will be assigned to receive either NW Roselle or an active control Captopril 25 mg twice daily
Before the treatment begins participants will provide informed consent and undergo assessments to collect information about their medical history hypertension status lifestyle factors and demographics Throughout the trial the participants vital signs physical exams and laboratory tests will be conducted to monitor their health and response to the treatment Adherence to the assigned treatment will be monitored and any potential adverse events or side effects will be tracked
In this Phase III clinical trial researchers are evaluating the efficacy and safety of NW Roselle in the treatment of Grade 1 essential hypertension Eligible participants who meet the criteria will be enrolled and randomized in a 11 ratio They will be assigned to receive either NW Roselle or an active control Captopril 25 mg twice daily
Before the treatment begins participants will provide informed consent and undergo assessments to collect information about their medical history hypertension status lifestyle factors and demographics Throughout the trial the participants vital signs physical exams and laboratory tests will be conducted to monitor their health and response to the treatment Adherence to the assigned treatment will be monitored and any potential adverse events or side effects will be tracked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None