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

Abdul Bari

Status and phase: Enrolling; Phase 3

Conditions: Hypertension

Treatments: Other: Qurs e Fishar

Study type: Interventional

Funder types: Other

Identifiers

NCT06852079

QF-HLWP

Details and patient eligibility

About

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.

Enrollment: 119 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Effect of Qurs e Fishar on Hypertension

Experimental group

Treatment:

Other: Qurs e Fishar