A Clinical Study to Evaluate the Efficacy and Safety of Tukhm-i Kahu in the Management of Zaght al-Dam Qawi Lazimi (Essential Hypertension)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Systolic and Diastolic BP from baseline to last follow up
研究概览
简要总结
Hypertension is a common lifestyle disorder with a very strong risk factor predilection for cardiovascular diseases. Several surveys in the last two decades have reported a prevalence of 6.1% to 36.35% in men and 2%-39.4% in women in urban areas, and from 3%-36% in men and 5.8%-37.2% in women in rural areas respectively .The prevalence of hypertension increases with age and it is estimated that starting from around 15% -20% in early age, it increases to 75% -80% in individuals above 70 years of age.
In conventional medicine, certain classes of antihypertensive drugs such as diuretics, calcium channel blockers, ACE inhibitors and Beta-blockers etc are in vogue with certain degree of adverse effects including hyperkalaemia, metabolic acidosis, gynaecomastia, hypotension etc with some contraindications such as COPD, gout, heart block and renal artery stenosis. Furthermore, some of these medicines are much costly. Hence, the alternative therapies should be explored for the better and safe management of hypertension.
In Unani system of medicine, hypertension has been described under the term Imtila and various single and compound Unani drugs have been mentioned for its management such as Tukhm-i Kahu, Asrol, Parsiaoshan, Dawa-us-Shifa, Habb-e-Mudir, Sharbat-e-Buzoori, etc..
Tukhm-i Kahu is one among the best Mudir (Diuretic) Advia. Besides of being Mudir, it also reduces the Hiddat of Khun leading to reduction in Imtilaand signs and symptoms associated with hypertension.
Keeping the above facts inview, it has been planned to conduct a clinical trial entitled “A ClinicalStudy to Evaluate the Efficacy and Safety of Tukhm-i Kahu inthe Management of Zaghá¹ al-Dam Qawi Lazimi (EssentialHypertension)â€.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •All subjects will meet the following criteria: 1-Patients of any sex in the age group of 35 to 55 years 2-Patients having Stage-I Hypertension according to JNC-8 (Systolic BP 140-159 and Diastolic BP 90-99 mmHg) with or without the following symptoms: 3-Suda (Headache) 4-Khafaqan (Palpitation) 5-Kasal (Laziness) 6-Qalaq (Anxiety) 7-Usr al-Tanaffus (Breathlessness) 8-Nabz Mumtali (Pulsus plenus) 9-Clinically stable patients 10-Patients not taking any anti-hypertensive drugs 11-Patients willing to sign the informed consent form.
排除标准
- •Patients will be excluded if they meet any of the following criteria: 1-Patient with SBP ≥160 mmHg and DBP ≥100 mmHg 2-Patients of Secondary Hypertension 3-Pregnant and Lactating women 4-Obese subjects – BMI >30 5-Drug Addicts, Alcoholics 6-Patients not willing to give consent 7-Patients not willing to come for follow-up.
结局指标
主要结局
Reduction in Systolic and Diastolic BP from baseline to last follow up
时间窗: On 7th 14th 21st 28th 35th and 42nd day from baseline
次要结局
- 1-Improvement in Signs and Symptoms of Hypertension(2-Haematological and Biochemical Assessments for Safety)