Influence of Herbal Infusion of Cumin Seed, Ginger Root and Lemon Peel on Clinical Outcomes Among Patients With Hyperuricemia Associated Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Waist Circumference
研究概览
简要总结
After taking written informed consent patients, the selected participants were divided into control and experimental group randomly.
详细描述
Phase II: RCT Double- Blinded After the approval from the relevant authorities from The University of Lahore and Hospital, individuals meeting the ATP III criteria for metabolic syndrome (n = 330) will be selected for inclusion after taking consent. The selected participants will be randomly divided into control and experimental groups. Anthropometric measurements, socio-economic status, nutrient intake and biochemical tests as fasting blood sugar level, triglyceride and cholesterol levels were taken at beginning (0 day) and 60 days.
The study was conducted in three steps respectively I: Baseline Data II: Intervention III: Follow Up I: Baseline Data
Interview technique accompanied with questionnaire was used to get following information. Before intervention metabolic syndrome patients were assessed for:
Demographic Data:
The basic information based on demographic data such as age, gender, marital status, education, was taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double- Blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome patients either gender of 18 to 60 years will be included.
- •Patients will be recruited on the basis of ATP III criteria
- •Patients having any body mass index with confirmed diagnosis of Metabolic Syndrome and no use of any dietary supplement or no adherence to special diets at least one month prior to baseline
排除标准
- •Individuals with the following conditions will not be included as participants
- •Genetically obese individuals
- •Patients already on lipid lower drugs according to recommendation of physicians
- •Patients taking any nutritional supplement
- •Allergy to any drugs or specific foods
- •Breastfeeding mothers
- •Pregnant females
- •Patients with any other medical history (renal diseases, infections, liver disorders, cardiovascular diseases)
- •Patients receiving weight loss drugs or supplements, receiving any changes in diet or daily exercise programs
研究组 & 干预措施
Conventional therapy group
Control group on Carbohydrate Controlled Diet with conventional therapy
干预措施: Conventional therapy (Dietary Supplement)
Cumin tea group
Intervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea
干预措施: Cumin tea (Dietary Supplement)
Ginger Tea Group
Intervention with Carbohydrate Controlled Diet along with Ginger Tea
干预措施: Ginger Tea (Dietary Supplement)
Lemon Peel Tea Group
Intervention with Carbohydrate Controlled Diet along with Lemon Peel Tea
干预措施: Lemon Peel Tea (Dietary Supplement)
Functional tea Group
: Intervention with Carbohydrate Controlled Diet along with Functional Tea
干预措施: Functional Tea (Dietary Supplement)
结局指标
主要结局
Waist Circumference
时间窗: 60 days
Normal range of waist circumference in men should be less than 40 inches and in women it should be less than 35 inches. Change in the waist circumference will be monitored during the trial. \>102 cm ( \>40 in ) \>88 cm ( \>35 in )
Serum Triglyceride Level
时间窗: 60 days
Change in serum Triglyceride Level were monitored before and after the trial
Serum HDL- Cholesterol Level
时间窗: 60 days
Change in Levels were monitored before and after the trial
Blood Pressure (Systolic and Diastolic)
时间窗: 60 days
Change in readings were monitored before and after the trial
Fasting Glucose Level
时间窗: 60 days
Change in readings were monitored before and after the trial
次要结局
未报告次要终点
研究者
Maria Aslam
Maria Aslam
University of Lahore