RecruitingPhase 3NCT06852079

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


Sponsor

Abdul Bari

Enrollment

119 participants

Start Date

Dec 23, 2023

Study Type

INTERVENTIONAL

Conditions

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. Secondary End Points: 1\. Compliance of the prescribed study medication.


Eligibility

Min Age: 30 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria7

  • Patients with recent history of following will be excluded:
  • Severe hypertension,
  • Congestive cardiac failure,
  • Left ventricular failure,
  • Myocardial ischemia,
  • Renal failure or
  • Cerebrovascular accidents

Interventions

OTHERQurs e Fishar

Qurs e Fishar is a herbal remedy for Hypertension


Locations(1)

Taj Medical Complex, Hamdard University Hospital

Karachi, Sindh, Pakistan

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NCT06852079


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