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Combined Effects of Withania Somnifera & Syzgium Cumini on Hyperlipidemia

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A (control group)
Participants in the control group (A) were instructed to take Atorvastatin 10 mg HS, their usual medication for hyperlipidemia.
Andet: Atorvastatin 10mg
In this intervention, participants were instructed to take their usual medication for hyperlipidemia they were taking before.
Andre navne:
  • Group A (control group)
Eksperimentel: Group B (treatment group 1)
This group received Withania somnifera (500mg capsule BD).
Kosttilskud: Group B (treatment group 1)
In this intervention, participants were instructed to take Withania somnifera (500mg) twice a day (BD).
Eksperimentel: Group C (treatment group 2)
This group received Syzygium cumini (500mg capsule BD).
Kosttilskud: Group C (treatment group 2)
In this intervention, participants were instructed to take Syzgium cumini (500mg) twice a day (BD).
Eksperimentel: Group D (treatment group 3)
This group received a combination of Withania somnifera and Syzygium cumini (1000 mg QD each).
Kombinationsprodukt: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Levels of Lipid Profile
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Riphah International University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • Tambe, B. D., et al. (2021).

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. maj 2023

Primær færdiggørelse (Faktiske)

10. oktober 2023

Studieafslutning (Faktiske)

25. oktober 2023

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REC/RCR&AHS/23/0811

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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