A clinical trial to compare the effects coded Unani drug UNIM-904 with allopathic drug Amlodipine in patients with Essential Hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: null- Zaghtuddam Qawi Lazmi (Essential Hypertension)
- Registration Number
- CTRI/2013/10/004091
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 480
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction in Systolic and Diastolic BP <br/ ><br>2.Improvements in signs and symptoms of Hypertension <br/ ><br>3.Hematological and biochemical assessments for safety <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Hematological and biochemical assessments for safety <br/ ><br>Timepoint: 12 weeks