NCT06852079

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. 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. 2.Type, frequency and severity of ADRs during the study period.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
119

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Dec 2023

Typical duration for phase_3 hypertension

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 Start

First participant enrolled

December 23, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

February 24, 2025

Last Update Submit

February 24, 2025

Conditions

Keywords

HTNHypertensionQurs e Fishar

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

EXPERIMENTAL
Other: Qurs e Fishar

Interventions

Qurs e Fishar is a herbal remedy for Hypertension

Effect of Qurs e Fishar on Hypertension

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Taj Medical Complex, Hamdard University Hospital

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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

Locations