Safety & Efficacy of Qurs e Fishar in Mild to Moderate Hy... | NCT06852079

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

NCT06852079

Sponsor

Abdul Bari

Status

Recruiting

Last Update Posted

Feb 28, 2025Actual

Enrollment

119Estimated

Phase

Phase 3

Conditions

Hypertension

Interventions

Qurs e Fishar

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2023Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 24, 2025

First Submission Date that Met QC Criteria

Feb 24, 2025

First Posted Date

Feb 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 28, 2025Actual

Name	Class
Hamdard University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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:

1. Compliance of the prescribed study medication.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Effect of Qurs e Fishar on Hypertension	Experimental		Other: Qurs e Fishar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Qurs e Fishar	Other	Qurs e Fishar is a herbal remedy for Hypertension	Effect of Qurs e Fishar on Hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taj Medical Complex, Hamdard University Hospital	Recruiting	Karachi	Sindh		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided