HyperlipidemiasNCT07578857
Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia
A study testing Atorvastatin 10mg, Group B (treatment group 1) and Group C (treatment group 2) in people with Hyperlipidemias, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Atorvastatin 10mg, Group B (treatment group 1) and Group C (treatment group 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 24 May 2023to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperlipidemias
- Being tested
- Atorvastatin 10mg, Group B (treatment group 1), Group C (treatment group 2), Group D (treatment group 3)
- Keywords
- Withania somnifera, Syzygium cumini, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10mgOther
Also called Group A (control group)
In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Atorvastatin 10mg |
| Group B (treatment group 1) | Experimental | This group received Withania somnifera (500mg capsule BD). Receives: Dietary Supplement: Group B (treatment group 1) |
| Group C (treatment group 2) | Experimental | This group received Syzygium cumini (500mg capsule BD). Receives: 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). Receives: Combination Product: Group D (treatment group 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Levels of 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 effects of the individual and combined treatment.
Measured: 3 months
Secondary outcomes (3)
Change in Body Weight
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.
Measured: 3 months
Change in Body Mass Index (BMI)
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.
Measured: 3 months
Change in Blood Pressure
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start24 May 2023
- Primary completion10 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Dr. Muhammad Imran Hussain, Study director, Rashid Latif Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578857
- Sponsor's protocol ID
- REC/RCR&AHS/23/0811
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Withania Somnifera and Syzygium Cumini on Hyperlipidemic Patients
- ClinicalTrials.gov ID
- NCT07578857
- Acronym / sponsor ID
- REC/RCR&AHS/23/0811
- Conditions
- Hyperlipidemias
- Keywords
- Withania somnifera, Syzygium cumini, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A (control group) | Active comparator | Other: Atorvastatin 10mgParticipants in the control group (A) were instructed to take Atorvastatin 10 mg HS, their usual medication for hyperlipidemia. |
| Group B (treatment group 1) | Experimental | Dietary Supplement: Group B (treatment group 1)This group received Withania somnifera (500mg capsule BD). |
| Group C (treatment group 2) | Experimental | Dietary Supplement: Group C (treatment group 2)This group received Syzygium cumini (500mg capsule BD). |
| Group D (treatment group 3) | Experimental | Combination Product: Group D (treatment group 3)This group received a combination of Withania somnifera and Syzygium cumini (1000 mg QD each). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Pregnant and lactating women.
- Patients with chronic diseases or illness.
- Individuals with any food allergies.
- Individuals with congenital abnormalities.
- Individuals with psychological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 10mgAlso: Group A (control group)In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before. | Other | Group A (control group) |
| Group B (treatment group 1)In this intervention, participants were instructed to take Withania somnifera (500mg) twice a day (BD). | Dietary supplement | Group B (treatment group 1) |
| Group C (treatment group 2)In this intervention, participants were instructed to take Syzgium cumini (500mg) twice a day (BD). | Dietary supplement | Group C (treatment group 2) |
| 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). | Combination product | Group D (treatment group 3) |
Primary outcome
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 secondary outcomes
Change in Body Weight
Time frame: 3 months
Change in Body Mass Index (BMI)
Time frame: 3 months
Change in Blood Pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Hypercholesterolemia, Atherosclerosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Dr. Muhammad Imran Hussain study director
Rashid Latif Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 10mg, Group B (treatment group 1) and Group C (treatment group 2) in people with Hyperlipidemias, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Levels of Lipid Profile (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.