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临床试验/CTRI/2025/01/078859
CTRI/2025/01/078859尚未招募2/3 期

Efficacy of Arq-e-Zeera and Qurs-e-Tabasheer in the Secondary Prevention of Metabolic Syndrome: An Open Intervention Study

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年4月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
46
试验地点
1
主要终点
Improvement in symptoms and investigations

研究概览

简要总结

The metabolic syndrome (MetS) consists of a constellation of metabolic abnormalities that confer an increased risk of cardiovascular disease (CVD) and diabetes mellitus and it has gained significant interest worldwide due to its escalating prevalence, which places a heavy burden on the global healthcare system. According to IDF & AHA/NHLBI (2009) criteria, A person to be diagnosed with MetS, he/she should have 3 or more of the 5 components of MetS. They are: central obesity, hypertriglyceridemia, low HDL-C, hypertension and hyperglycemia.

The MetS hasn’t been described in Unani classical literature. But, according to Unani physicians, the key risk factors of MetS i.e. diabetes mellitus, obesity, high blood pressure and abnormal blood lipids have been described separately as different disease conditions. There are several single and compound drugs have been mentioned in Unani classical texts to treat each component of MetS separately. But as a syndrome its components vary from person to person. Therefore it is aimed to select Arq- e-Zeera and Qurs-e- Tabasheer in combination to evaluate their combined effect in the secondary prevention of Metabolic syndrome.

Clinically knownand newlydiagnosed cases of MetS, if fulfilling selection criteria will be selected and enrolled after obtaining written informed consent. Subjects will be administered with  75 ml of Arq-e-Zeera twice a day before meals and 3 Tablets of Qurs-e-Tabasheer twice a day after meals for 60 days. Followup will be done on 0th, 15th, 30th, 45th and 60th days. Baseline examination and 60th day examination will be analyzed statistically. The data on objective parameters will be recorded in a specialized case report form (CRF). Outcome of the study will be compared with the findings of baseline and after completion of the study.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • All gender Patients between 20 to 60 years of age BMI of 18.50 to 34.99 kg/m2 Patients with three or more out of the five components of Metabolic syndrome by IDF & AHA/NHLBI (2009) criteria Patients having normal to moderate degrees of those morbidities or co-morbidities Patients on medications for Diabetes mellitus Type 2 Patients on medications for Hypertension.

排除标准

  • Unstable, bedridden, mentally retarded, and with serious illness Pregnant and lactating mothers Uncontrolled Diabetes Mellitus Type 2 (FBG more or equal 200mmHG, PPBS more or equal 300mmHG ) Uncontrolled Hypertension (SBP more than 159 mmHg and DBP more than 99 mmHg) Patients not willing to give written consent.

结局指标

主要结局

Improvement in symptoms and investigations

时间窗: Intervention Period 60 days and outcome will be assessed on 60th day. Baseline and 60th day examinations will be analyzed. | Enrolment Period 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other [National Institute for Researches, Prevention and Cure in Unani System of Medicine]
责任方
Principal Investigator
主要研究者

Ahamed Shifak Fathima Shifra

National Institute of Unani Medicine

研究点 (1)

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