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Clinical study to evaluate the efficacy and safety of a unani drug in the management of hypertension.

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Unani Pharmacopoeial Formulation â?? Asrin in the Management of á¸?aght al-Dam Qawá¿? LÄ?zimá¿? (Essential Hypertension)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050259
Enrollment
62
Registered
2023-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: Asrin: Dosage Form: Qurs (Tablet), Dosage: Two Tablets (500 mg each) twice a day after meals, Route of Administration: Oral, Composition: 1. Bekh-e-Asrol (Rauwolfia serpentina) 2.5 K

Sponsors

National Research Institute of Unani Medicine for Skin Disorders.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of any sex aged 35-65 years 2. Stage-I Hypertension according to JNC 7 (Systolic BP 140-159 & Diastolic BP 90-99 mmHg) 3. Participants willing to sign the informed consent form and to comply with the protocol

Exclusion criteria

Exclusion criteria: 1. Participants aged 65 years 2. Participants with SBP >=160 mmHg and DBP >=100 mmHg 3. Participants with Secondary Hypertension and Type 2 DM 4. Known cases of significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc. 5. Pregnancy and Lactation 6. Known allergy, sensitivity or intolerance to the study drug or any of its ingredients 7. Any other clinical condition that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the trial

Design outcomes

Primary

MeasureTime frame
Reduction in SBP â?¥ 20 mmHg and diastolic blood pressure â?¥ 10 mmHg from baseline.Timepoint: 4 Weeks

Secondary

MeasureTime frame
Systemic safety assessmentTimepoint: 4 Weeks

Countries

India

Contacts

Public ContactDr Mohammad Mubashshir Arfee

National Research Institute of Unani Medicine for Skin Disorders.

ccrumnawab@gmail.com8100992044

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026