A clinical trial to compare the effects coded Unani drug UNIM-904 with allopathic drug Amlodipine in patients with Essential Hypertension.

A Multi centric, Single Blind, Randomized, parallel group study to compare efficacy and safety of coded unani formulation UNIM-904 with Amlodipine in patients with Zaghtuddam Qawi Lazmi (Essential Hypertension)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004091

Enrollment

480

Registered

2013-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Health Condition 2: null- Zaghtuddam Qawi Lazmi (Essential Hypertension)

Interventions

Intervention1: UNIM-904: Formulation: UNIM-904 (Sachets containing 5 g granules) Route of administration: Oral Dose regimen: 1 Sachet (5 g) BD Â½ hr before breakfast and dinner D

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex in the age group of 18-65 years. 2. Patients of Hypertension with SBP 160-179 mmHg and DBP 90-100 mmHg and/or 3.Presence of any of the following signs and symptoms: •Suda (Headache) •Duwar (Vertigo) •Khafaqan (Palpitation) •Kasal (Laziness) •Qalaq (Anxiety) •Usr al-Tanaffus (Breathlessness) • Takaddur fiâ??l Hawas (Diminished Alertness) •Jiryan al-Dam zer Multahima (Subconjunctival Haemorrhage) •Ruâ??af (Epistaxis) •Nabz Mumtali (Pulsus plenus)

Exclusion criteria

Exclusion criteria: 1.Patient with SBP >=180 mmHg and DBP 100 mmHg 2.Patients of Secondary Hypertension 3.Pregnant and lactating women 4.Females using oral contraceptive pills 5.Patients taking any other medication affecting blood pressure like NSAIDs. 6.Abnormality in investigations done at baseline (SGPT 105 IU) 7.Obese subjects â?? BMI 30 8.Disorders requiring long term-treatment, e.g, diabetes mellitus 9.Drug addicts, Alcoholics /Malignancy /Epilepsy /CAD/CKD 10.Patients with Sinus Bradycardia, i.e., pulse rate less than 60/min

Design outcomes

Primary

Measure	Time frame
1.Reduction in Systolic and Diastolic BP 2.Improvements in signs and symptoms of Hypertension 3.Hematological and biochemical assessments for safety Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Hematological and biochemical assessments for safety Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Abdul Hannan

in Unani Medicine (CCRUM

ccrum605@gmail.com011-28521981

Outcome results

None listed

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