A Multi centric, Single Blind, Randomized, parallel groupstudy to compare efficacy and safety of coded unaniformulation UNIM-904 with Amlodipine in patients withZaghtuddam Qawi Lazmi (Essential Hypertension)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 480
- Locations
- 4
- Primary Endpoint
- 1.Reduction in Systolic and Diastolic BP
Study Overview
Brief Summary
This study is designed as a multicentric controlled trial in patients with Zaghtuddam Qawi Lazmi (Essential Hypertension). The patient will be evaluated for hypertension at 3 consecutive visits at the same time & if blood pressure is found to be persistently high during rest (both mental and physical) the patient will be subjected to screening. After screening, participants will be divided into 2 arms. First arm will receive the study drug–UNIM-904 in the dose of 5 gm BD while the second arm will receive standard anti-hypertensive drug Amlodipine 5 mg OD.
The total duration of treatment will be 12 weeks and the follow-up for all clinical parameters will be conducted weekly for 4 weeks and once in 2 weeks thereafter. The laboratory tests will be conducted at baseline, 2 weeks and last follow-up.
Composition of UNIM 904
Ud Salib…….21/2 parts
KariPatta……2 ½ Parts
Bahman eSurkh..1 Part
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex in the age group of 18-65 years.
- •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 fi’l Hawas (Diminished Alertness) •Jiryan al-Dam zer Multahima (Subconjunctival Haemorrhage) •Ru’af (Epistaxis) •Nabz Mumtali (Pulsus plenus).
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 – 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.
Outcomes
Primary Outcomes
1.Reduction in Systolic and Diastolic BP
Time Frame: 12 weeks
2.Improvements in signs and symptoms of Hypertension
Time Frame: 12 weeks
3.Hematological and biochemical assessments for safety
Time Frame: 12 weeks
Secondary Outcomes
- Hematological and biochemical assessments for safety