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

Phase 2

Recruiting

• Conditions: Essential (primary) hypertension, Zaghtuddam Qawi Lazmi (Essential Hypertension) ,

• Registration Number: CTRI/2013/10/004091
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-25
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Improvements in signs and symptoms of Hypertension	12 weeks
3.Hematological and biochemical assessments for safety	12 weeks
1.Reduction in Systolic and Diastolic BP	12 weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety

Trial Locations

Locations (4)

Central Research Institute of Unani Medicine (CRIUM), Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE; 🇮🇳 JAMMU, & KASHMIR, India

Regional Research Institute of Unani Medicine(RRIUM), Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, NEW DELHI; 🇮🇳 South, DELHI, India

Central Research Institute of Unani Medicine (CRIUM), Hyderabad

🇮🇳Hyderabad, ANDHRA PRADESH, India

DR MANZOOR AHMAD

Principal investigator

040-23810246

drsmanzoor@gmail.com