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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group B (treatment group 1) | Experimental | This group received Withania somnifera (500mg capsule BD). |
|
| Group C (treatment group 2) | Experimental | This group received Syzygium cumini (500mg capsule BD). |
|
| Group D (treatment group 3) | Experimental | This group received a combination of Withania somnifera and Syzygium cumini (1000 mg QD each). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10mg | Other | In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Change in Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Dr. Muhammad Imran Hussain | Rashid Latif Khan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Imran Hussain | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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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.
|
| 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). |
|
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 | 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 |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |