Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan
1 other identifier
interventional
119
1 country
1
Brief Summary
The herbal medicine Qurs-e-Fishar to treat mild to moderate High blood pressure or hypertension comprises of Rauwolfia serpentina. A product of Hamdard Laboratories (Waqf) Pakistan. A Phase III Safety \& Efficacy Open-label, Single-Arm, Interventional, Multicenter, Study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days). Primary End Points:
- 1.Reduction in diastolic blood pressure less than 130 / 80 mmHg at the end of the study period (accepted by WHO) or if there was a fall of 20 / 10 mmHg or more in diastolic blood pressure as compared to baseline.
- 2.Type, frequency and severity of ADRs during the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Dec 2023
Typical duration for phase_3 hypertension
1 active site
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 Start
First participant enrolled
December 23, 2023
CompletedFirst Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 28, 2025
February 1, 2025
1.5 years
February 24, 2025
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure
Blood pressure (in mmHg) will be measure at baseline and again at first follow-up (4th week), than at second follow-up (at 8th week) the end of treatment (12th week).
12 weeks
Study Arms (1)
Effect of Qurs e Fishar on Hypertension
EXPERIMENTALInterventions
Qurs e Fishar is a herbal remedy for Hypertension
Eligibility Criteria
You may qualify if:
- Ability to sign ICD
- Participant(s) are willing and able to fulfill the requirements of the study protocol
- Mild to moderate hypertensive
- Mild hypertension range (140-159/90-99 mm Hg)
- Moderate hypertension range (160-179/100-109 mm Hg)
- Be between the age of 30 to 60 year
You may not qualify if:
- Patients with recent history of following will be excluded:
- Severe hypertension,
- Congestive cardiac failure,
- Left ventricular failure,
- Myocardial ischemia,
- Renal failure or
- Cerebrovascular accidents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abdul Barilead
- Hamdard Universitycollaborator
Study Sites (1)
Taj Medical Complex, Hamdard University Hospital
Karachi, Sindh, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
February 24, 2025
First Posted
February 28, 2025
Study Start
December 23, 2023
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share