NCT05851040

Brief Summary

Antioxidant qualities have been attributed to wheatgrass and tulsi formulation. Free radicals are unstable molecules created by the body during metabolism and exposure to environmental pollutants. Antioxidants are chemicals that can help stop or reduce cell damage caused by these unstable molecules. Oxidative stress, which is brought on by free radicals, has been connected to a number of health issues, including chronic inflammation, cardiovascular disease, cancer, and ageing. Wheatgrass is a rich source of vitamins, minerals, amino acids, and chlorophyll, which have been shown to have antioxidant and anti-inflammatory effects. Tulsi, also known as holy basil, is an herb that has been used in Ayurvedic medicine for centuries and has been found to have antioxidant, anti-inflammatory, and immunomodulatory properties. Several studies have investigated the antioxidant properties of wheatgrass and tulsi formulation. For instance, a study published in the Journal of Food Science and Technology in 2015 found that wheatgrass extract had significant antioxidant activity, as measured by its ability to scavenge free radicals and reduce lipid peroxidation in vitro.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 25, 2023

Last Update Submit

May 5, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Effect of wheat grass and tulsi in combination on blood pressure

    Blood Pressure measured in mmHg every four week.

    Every four week till 6 months

  • Effect of wheat grass and tulsi in combination on blood sugar

    Blood Sugar measured in mmol/L every four week

    Every four week till 6 months

  • Effect of wheat grass and tulsi in combination on weight

    Weight is measure in Kg every four week.

    Every four week till 6 months

  • Effect of wheat grass and tulsi in combination on smoking

    questionnaire assesment for "Smoking habits"

    Every four week till 6 months

Secondary Outcomes (8)

  • Effect of wheat grass and tulsi separately on blood pressure

    Every four week till 6 months

  • Effect of wheat grass and tulsi separately on blood sugar

    Every four week till 6 months

  • Effect of wheat grass and tulsi separately on weight

    Every four week till 6 months

  • Effect of wheat grass and tulsi separately on smoking

    Every four week till 6 months

  • Effect of wheat grass, tulsi and allopathic drug on blood pressure

    Every four week till 6 months

  • +3 more secondary outcomes

Study Arms (3)

With Wheatgrass, tulsi formulation

People using Wheatgrass and Tulsi formulation or individual

Other: Observation study

With Wheatgrass, tulsi formulation and allopathic drugs

People using Wheatgrass and Tulsi formulations or individuals with chronic disease medicine.

Other: Observation study

Same age group not using any medication

Other: Observation study

Interventions

Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug

Same age group not using any medicationWith Wheatgrass, tulsi formulationWith Wheatgrass, tulsi formulation and allopathic drugs

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of age group 30 to 65 is targeted who have chronic disease and are taking wheat grass and tulsi formulation.

You may qualify if:

  • Patients who are having a chronic disease and taking formulation wheat grass and tulsi.
  • Patients who are taking wheatgrass and tulsi separately.
  • Patients who are taking wheatgrass, tulsi and regular medicine. -

You may not qualify if:

  • Patients below 30 years.
  • Patients who are having a chronic disease but not using formulations of wheatgrass and tulsi.
  • Patients who are not taking wheatgrass and tulsi separately.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinhgad college of Pharmacy

Pune, Maharashtra, 411041, India

Location

MeSH Terms

Conditions

HypertensionHyperglycemiaBirth WeightSmoking

Interventions

Observational Studies as Topic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 9, 2023

Study Start

May 10, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations