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临床试验/CTRI/2023/07/055796
CTRI/2023/07/055796尚未招募2 期

Evaluation of safety and efficacy of Zaranbad (Curcuma zedoaria Rosc.) in Primary hypertension- a randomized standard control trial.

Luqman Unani Medical College Hospital and Research Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年7月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Change in systolic & diastolic blood pressure

研究概览

简要总结

Hypertension ischaracterized by persistently high blood pressure (BP) in the systemic arteries1,2. BP is commonly expressed as the ratio of thesystolic BP (that is, the pressure that the blood exerts on the arterial wallswhen the heart contracts) and the diastolic BP (the pressure when the heartrelaxes)1. According to AHA Hypertensionis diagnosed if, when it is measured on two different days, Hypertension is diagnosed when blood pressure isconsistently ≥130 and/or ≥80 mm Hg3. Hypertension is a serious medical conditionthat significantly raises the chances of heart, brain , kidney, and otherdiseases and is a leading cause of premature death globally, An estimated 1.28billion individuals aged 30-79 years worldwide have hypertension, most(two-thirds) living in low- and middle-income countries, An estimated 46 % ofadults with hypertension are unaware of the condition and 42  adultswith hypertention are diagnosed and treated1. Hypertension is classified as either primary (essential)or secondary hypertension, Primaryhypertension accounts for âˆ¼90% of cases of hypertension and has no detectable cause, whereassecondary hypertension  is caused by a specific underlying condition whichinclude renal, endocrine, and vascular diseases2,4 . Non-modifiable risk factors includes Age,gender, genetic factors and ethnicity ,Modifiable risk factors includesObesity,excessive salt intake, saturated fat, physical inactivity,  alcohol, environmental stress and otherfactors5. Early symptoms ofhypertension includes chest pain, shortness ofbreath, palpitations, claudication, peripheral edema, headaches, nocturia anddizziness**. Signs and symptoms suggestive of secondaryhypertension i.e, organ damage include** myocardialinfarction , renal artery stenosis, and stroke1,2,5,6. Hypertension is treated with antihypertensive medications either inmonotherapy or in Combination therapy, drugs include ACE inhibitors, thiazidediuretics, angiotensin II receptor blockers and calcium-channel blockers 2,5,7. These drugs areable to control the blood pressure but associated with serious side effects such as hyperglycemia, ,impotence, depression, vomiting, drowsiness, fatigue, dizziness, diarrhea, lossof taste ,cramps, dryness of mouth, leucopenia, and constipation8.Although hypertension has notspecifically described as such in the classical Unani text, it has beenidentified by virtue of its clinical symptoms, which primarily match those ofthe humoral disease “ImtilÄ ba hasbal-awiyyaâ€9. This condition can becharacterized as fullness of vessels with an abnormally high volume of blood7,9. The treatment of thiscondition is focused on the removal of excessive humour from the body;therefore, therapeutic interventions such as idrÄr (diuresis) and faá¹£d(venesection),which help to minimise excess humour, can be helpful 5,7, TaskÄ«n-i Qalb (Tonormalize the heart rate)10TafrÄ«h (Exhilaration) 10Tawsī‘-i UrÅ«q(Dilatation of blood vessels) in case of narrowing of vessels  TaqlÄ«l-i GhizÄ (To reduce the quantityof food)11,TahzÄ«l (To reduce thebody weight) 10, IslÄh-i NizÄm-i Hazm(To correct the digestive system)10.There are several single andcompound drugs advocated by renowned Unani scholars such as Tukhm-e-Kharpaza (Cucumis milo Linn.),Tukhm-e-Kheyarain (Cucumis sativa),Abresham (Silk coccoon), Sandal Sufaid(Santalum  album), Sankhaholi (Evolvulusalsinoides Linn.) ,Asrol (Rauwolfia serpentina), Ood e Saleeb (Poeniaofficinalis) etc. and compound drugssuch as Qurs Tabasheer Kafoori, Sharbat-e-Nilofar5. Zaranbad is repeatedly described in classical Unani text foreffective treatment of symptoms of hypertension which acts as Mufarriḥ (exhilarant)wa muqawwÄ« qalb(cardiac tonic)12–14, mufattiḥ sudad (deobstruent)13 and mudirr-i bawl(diuretic)14. After extensive search ofliterature sources on hypertension, it is concluded that safety and efficacy ofthe selected drug was not evaluated on scientific parameters. Thus, presentstudy has been designed to evaluate the safety and efficacy of Zaranbadin the treatment of hypertension titled “Evaluation of safety and efficacy of Zaranbad(Curcuma zedoaria Rosc.) in Primary hypertension- a randomized standardcontrol trial.â€

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of grade1 hypertension.

排除标准

  • Pregnant and lactating women.
  • Patients suffering from any other systemic diseases.
  • Patients suffering from secondary hypertension.

结局指标

主要结局

Change in systolic & diastolic blood pressure

时间窗: Change in systolic & diastolic blood pressure baseline to end of treatment & every followup

次要结局

  • Quality of life MINICHAL(baseline & after treatment)

研究者

发起方
Luqman Unani Medical College Hospital and Research Center
申办方类型
Research institution and hospital

研究点 (1)

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