Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia

June 8, 2026 updated by: Riphah International University

Combined Effect of Withania Somnifera and Syzygium Cumini on Hyperlipidemic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Dr. Imran Hussain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (control group)
Participants in the control group (A) were instructed to take Atorvastatin 10 mg HS, their usual medication for hyperlipidemia.
Other: Atorvastatin 10mg
In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before.
Other Names:
  • Group A (control group)
Experimental: Group B (treatment group 1)
This group received Withania somnifera (500mg capsule BD).
Dietary supplement: Group B (treatment group 1)
In this intervention, participants were instructed to take Withania somnifera (500mg) twice a day (BD).
Experimental: Group C (treatment group 2)
This group received Syzygium cumini (500mg capsule BD).
Dietary supplement: Group C (treatment group 2)
In this intervention, participants were instructed to take Syzgium cumini (500mg) twice a day (BD).
Experimental: Group D (treatment group 3)
This group received a combination of Withania somnifera and Syzygium cumini (1000 mg QD each).
Combination product: Group D (treatment group 3)
In this intervention, participants were instructed to take both Withania somnifera and Syzgium cumini (1000 mg) once a day (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Director: Prof Dr. Muhammad Imran Hussain, Rashid Latif Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Tambe, B. D., et al. (2021).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 25, 2023

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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