HypertensionPhase 3NCT06852079
Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan
A Phase 3 study testing Qurs e Fishar in people with Hypertension, run by Abdul Bari at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Qurs e Fishar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Dec 2023to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Taj Medical Complex, Hamdard University Hospital
Karachi, Sindh
Zeenat Bukhari Study Coordinator, +923363725023, zeebukhari11@gmail.com
dradilfaraz@hotmail.com
About this study
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).
Read more
Primary End Points:
- 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.
- Type, frequency and severity of ADRs during the study period.
Secondary End Points:
- Compliance of the prescribed study medication.
- Conditions
- Hypertension
- Being tested
- Qurs e Fishar
- Keywords
- HTN, Hypertension, Qurs e Fishar
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qurs e FisharOther
Qurs e Fishar is a herbal remedy for Hypertension
| Study group | Role | What they receive |
|---|---|---|
| Effect of Qurs e Fishar on Hypertension | Experimental | Not described Receives: Other: Qurs e Fishar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start23 Dec 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdul Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Hamdard University
- Responsible party
- Sponsor-investigator, Abdul Bari, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852079
- Sponsor's protocol ID
- QF-HLWP
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hypertensive Patients in Pakistan
- ClinicalTrials.gov ID
- NCT06852079
- Acronym / sponsor ID
- QF-HLWP
- Conditions
- Hypertension
- Keywords
- HTN, Hypertension, Qurs e Fishar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Abdul BariUniversity, hospital or other
- Collaborators
- Hamdard University
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Type, frequency and severity of ADRs during the study period.
Secondary End Points:
- Compliance of the prescribed study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of Qurs e Fishar on Hypertension | Experimental | Other: Qurs e Fishar |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- Patients with recent history of following will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qurs e FisharQurs e Fishar is a herbal remedy for Hypertension | Other | Effect of Qurs e Fishar on Hypertension |
Primary outcome
Blood Pressure
Time frame: 12 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taj Medical Complex, Hamdard University Hospital
Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Qurs e Fishar in people with Hypertension, run by Abdul Bari at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.