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Completed

NCT Number: NCT07578857

Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Imran Hussain

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Atorvastatin 10mg

Other

In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before.

Other names: Group A (control group)

Group B (treatment group 1)

Dietary Supplement

In this intervention, participants were instructed to take Withania somnifera (500mg) twice a day (BD).

Group C (treatment group 2)

Dietary Supplement

In this intervention, participants were instructed to take Syzgium cumini (500mg) twice a day (BD).

Group D (treatment group 3)

Combination Product

In this intervention, participants were instructed to take both Withania somnifera and Syzgium cumini (1000 mg) once a day (QD).

Primary outcomes

  1. Change in the Levels of Lipid Profile

    Time frame: 3 months

    Lipid profile was measured using a RX Daytona+ machine on the fasting for 9-12 hours. The difference between the before and after values was calculated to assess the effects of the individual and combined treatment.

Secondary outcomes

  1. Change in Body Weight

    Time frame: 3 months

    Body weight was measured using both digital and mechanical weight scale. The difference between the before and after values was calculated to assess the effects of the individual and combined treatment.

  2. Change in Body Mass Index (BMI)

    Time frame: 3 months

    Body mass index was calculated by using its standard formula in which weight in kilogram is divided by height in meter per square (weight (kg) / height (m2)). The difference between the before and after values was calculated to assess the effects of the individual and combined treatment.

  3. Change in Blood Pressure

    Time frame: 3 months

    Blood Pressure was measured by a sphygmomanometer. The difference between the before and after values was calculated to assess the effects of the individual and combined treatment.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effect of Withania Somnifera and Syzygium Cumini on Hyperlipidemic Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 11, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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