Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan

NCT ID: NCT06852079

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-23

Study Completion Date

2025-12-31

Brief Summary

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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.

Secondary End Points:

1\. Compliance of the prescribed study medication.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Effect of Qurs e Fishar on Hypertension

Group Type EXPERIMENTAL

Qurs e Fishar

Intervention Type OTHER

Qurs e Fishar is a herbal remedy for Hypertension

Interventions

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Qurs e Fishar

Qurs e Fishar is a herbal remedy for Hypertension

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with recent history of following will be excluded:

* Severe hypertension,
* Congestive cardiac failure,
* Left ventricular failure,
* Myocardial ischemia,
* Renal failure or
* Cerebrovascular accidents
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamdard University

OTHER

Sponsor Role collaborator

Abdul Bari

OTHER

Sponsor Role lead

Responsible Party

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Abdul Bari

Co-Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Taj Medical Complex, Hamdard University Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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Zeenat Bukhari Study Coordinator

Role: primary

+923363725023

Role: backup

Other Identifiers

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QF-HLWP

Identifier Type: -

Identifier Source: org_study_id

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