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临床试验/NCT07578857
NCT07578857已完成不适用

Combined Effect of Withania Somnifera and Syzygium Cumini on Hyperlipidemic Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1

研究概览

简要总结

Withania somnifera and Syzygium cumini are known for their potential therapeutic effects, particularly in managing lipid disorders. This study was aimed to provide valuable insights into their separate and synergistic effect of Withania somnifera (Ashwagandha) and Syzygium cumini (Jamun) on hyperlipidemic patients. The study included 60 patients, equally divided into four groups. Pre- and post-treatment assessments were conducted over 3 months. Each group recieved different treatment. Data was analyzed using SPSS version 21 through paired sample t-test. The findings of the research showed that Withania somnifera showed significant improvement in improving lipid profile and associated factors and concluded that the combination may be an effective and safe approach for managing hyperlipidaemia due to its beneficial impact on lipid profile.

详细描述

Hyperlipidemia is a defect of lipid metabolism with high levels of total cholesterol, triglycerides and low-density lipoprotein and reduced high-density lipoprotein levels. In Pakistan, the overall prevalence of dyslipidemia was determined to be 96%. Diabetes, obesity and hypertension were discovered as important risk factors. According to WHO, around 80% of population globally believes in botanical drugs and for many years they are using plants extract and their components for managing dyslipidemia. Withania somnifera, popularly known as "Ashwagandha" is rich in phytochemicals and terpenoids. Its root powder has been effective in decreasing total lipids, cholesterol and triglycerides and can increase high-density cholesterol levels. In addition, Syzgium cumini, commonly known as "Jamun". Its seeds possess lipid lowering properties and are able to reduce ratio of total serum cholesterol and high-density lipoprotein cholesterol, serum low density lipoproteins and triglycerides level. This study was therefore aimed to provide valuable insights into their separate and synergistic effect of Withania somnifera (Ashwagandha) and Syzygium cumini (Jamun) on lipid profile and associated factors including body weight, body mass index (BMI) and blood pressure.

The study design was a Randomized Controlled Trial. The data was collected from Mukhtiar Munir Hospital. Patients that were selected were given Withania somnifera and Syzgium cumini capsules (500mg BD) daily separately and in combination (1000 mg QD) for a duration of 3 months. Before intervention patients were assessed and then after 6 weeks reassessment was done. After the completion of 12 weeks patients' weight, BMI, lipid profile and blood pressure were assessed again. Data was recorded using Excel and IBM-SPSS statistical software version 21.0. Frequencies and percentages were recorded for baseline characteristics on SPSS descriptive scale. The means of two measurements (pre- and post-intervention) of each variable made of the same person were compared using the paired sample T-Test. Statistics were considered significant for p-values less than 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This was a randomized controlled trial. Participants were divided into four groups. One group was the "control group". They were instructed to take their usual medication for hyperlipidemia. While, participants in the experimental group (B, C and D) were asked to take Withania somnifera and Syzgium cumini separately and in combination.

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female participants.
  • Age group 25 - 65 years.
  • Participants with at least one of the given factors (cholesterol more than 200 mg/dl, LDL more than 130mg/dl, HDL less than 40 mg/dl, triglycerides more than 200 mg/dl, VLDL more than 30mg/dl and non-HDL cholesterol more than 160mg/dl)

排除标准

  • Pregnant and lactating women.
  • Patients with chronic diseases or illness.
  • Individuals with any food allergies.
  • Individuals with congenital abnormalities.
  • Individuals with psychological disorder.
  • Individuals with history of moderate to severe intensity of gastrointestinal issues.
  • Participants of treatment group must not be taking anti-hyperlipidemic medicines.

研究组 & 干预措施

Group B (treatment group 1)

Experimental

This group received Withania somnifera (500mg capsule BD).

干预措施: Group B (treatment group 1) (Dietary Supplement)

Group C (treatment group 2)

Experimental

This group received Syzygium cumini (500mg capsule BD).

干预措施: Group C (treatment group 2) (Dietary Supplement)

Group D (treatment group 3)

Experimental

This group received a combination of Withania somnifera and Syzygium cumini (1000 mg QD each).

干预措施: Group D (treatment group 3) (Combination Product)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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