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Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia

Combined Effect of Withania Somnifera and Syzygium Cumini on Hyperlipidemic Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07578857
Enrollment
60
Registered
2026-05-11
Start date
2023-05-24
Completion date
2023-10-25
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias

Keywords

Withania somnifera, Syzygium cumini, hyperlipidemia

Brief summary

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.

Detailed description

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.

Interventions

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

DIETARY_SUPPLEMENTGroup B (treatment group 1)

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

DIETARY_SUPPLEMENTGroup C (treatment group 2)

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

COMBINATION_PRODUCTGroup D (treatment group 3)

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Lipid Profile3 monthsLipid 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 effectiveness of the individual and combined treatment

Secondary

MeasureTime frameDescription
Improvement in Body Weight3 monthsBody weight was measured using both digital and mechanical weight scale. The difference between the before and after values was calculated to assess the effectiveness of the individual and combined treatment.
Improvement in Body Mass Index (BMI)3 monthsBody 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 effectiveness of the individual and combined treatment.
Improvement in Blood Pressure3 monthsBlood Pressure was measured by a sphygmomanometer. The difference between the before and after values was calculated to assess the effectiveness of the individual and combined treatment.

Countries

Pakistan

Contacts

STUDY_DIRECTORProf Dr. Muhammad Imran Hussain

Rashid Latif Khan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026