Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia

NCT07578857 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0811
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Keywords

Withania somnifera, Syzygium cumini, hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Improvement in Lipid Profile

  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 effectiveness of the individual and combined treatment

  3 months

Secondary Outcomes (3)

• Improvement in Body Weight

  3 months

• Improvement in Body Mass Index (BMI)

  3 months

• Improvement in Blood Pressure

  3 months

Study Arms (4)

Group A (control group)

ACTIVE COMPARATOR

Participants in the control group (A) were instructed to take Atorvastatin 10 mg HS, their usual medication for hyperlipidemia.

Drug: Atorvastatin 10mg

Group B (treatment group 1)

EXPERIMENTAL

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

Dietary Supplement: Group B (treatment group 1)

Group C (treatment group 2)

EXPERIMENTAL

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

Dietary Supplement: Group C (treatment group 2)

Group D (treatment group 3)

EXPERIMENTAL

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

Combination Product: Group D (treatment group 3)

Interventions

Atorvastatin 10mg DRUG

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

Also known as: Group A (control group)

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 B (treatment group 1)

Group C (treatment group 2) DIETARY_SUPPLEMENT

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

Group C (treatment group 2)

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).

Group D (treatment group 3)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Dr. Imran Hussain

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Tambe, B. D., et al. (2021).

  BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin; Control Groups

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Prof Dr. Muhammad Imran Hussain

  Rashid Latif Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 24, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 25, 2023
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)