Observe the Effect of Wheatgrass and Tulsi Formulation or Individuals Taken With Other Allopathic Drugs

Observation of Wheatgrass and Tulsi Formulation or Its Effect With Allopathic Drugs

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking; Blood Sugar; High; Blood Pressure, High; Weight, Birth
• Intervention / Treatment: Other: Observation study

Detailed Description

Similarly, a study published in the Journal of Ethnopharmacology in 2001 found that tulsi extract had significant antioxidant activity, as measured by its ability to scavenge free radicals and inhibit lipid peroxidation in vitro. Moreover, a study published in the Journal of Medicinal Food in 2011 investigated the antioxidant and anti-inflammatory effects of a combination of wheatgrass and tulsi extracts in rats. The study found that the combination of wheatgrass and tulsi extracts had significant antioxidant and anti-inflammatory effects, as measured by reductions in oxidative stress markers and pro-inflammatory cytokines. Overall, the available evidence suggests that wheatgrass and tulsi formulations may have antioxidant properties, which could potentially help prevent or slow down oxidative stress-related health problems. However, more research is needed to confirm these findings and determine the optimal dosage and duration of wheatgrass and tulsi formulation use for maximum antioxidant benefits. There are several studies that suggest wheatgrass and tulsi formulations have antioxidant properties. A study evaluated the immunomodulatory and antioxidant properties of a traditional formulation containing Tulsi, ginger, and wheatgrass. Another study investigated the antioxidant potential of anthocyanin extracts from colored wheat flour and wheat-grass juice. Additionally, a synergistic effect of conventional medicinal herbs against oxidative stress was observed in another study that included tulsi and wheatgrass. While a study compared the chemical composition, sensory, phenolic, and antioxidant properties of juices from different wheatgrass and turfgrass species, it did not specifically investigate a formulation with tulsi. Another study found that vitamin C is present in wheatgrass which is also an antioxidant.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Pravin Badhe, PhD; Phone Number: 91 7038248513; Email: drpravinbadhe@swalifebiotech.com

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411041
      • Sinhgad college of Pharmacy
      • Contact: Pravin Badhe, PhD; Phone Number: 91 7038248513; Email: drpravinbadhe@swalifebiotech.com
      • Principal Investigator: Pravin Badhe, PhD
      • Sub-Investigator: Ashwini Badhe, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With Wheatgrass, tulsi formulation; People using Wheatgrass and Tulsi formulation or individual	Other: Observation study; Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug
With Wheatgrass, tulsi formulation and allopathic drugs; People using Wheatgrass and Tulsi formulations or individuals with chronic disease medicine.	Other: Observation study; Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug
Same age group not using any medication	Other: Observation study; Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of wheat grass and tulsi separately on blood pressure	Blood Pressure measured in mmHg every four week.	Every four week till 6 months
Effect of wheat grass and tulsi separately on blood sugar	Blood Sugar measured in mmol/L every four week.	Every four week till 6 months
Effect of wheat grass and tulsi separately on weight	Weight is measure in Kg every four week.	Every four week till 6 months
Effect of wheat grass and tulsi separately on smoking	questionnaire assesment for "Smoking habits"	Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on blood pressure	Blood Pressure measured in mmHg every four week.	Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on blood sugar	Blood Sugar measured in mmol/L every four week.	Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on weight	Weight is measure in Kg every four week.	Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on smoking	questionnaire assesment for "Smoking habits"	Every four week till 6 months

Collaborators and Investigators

• Sponsor: Swalife Biotech

Publications and helpful links

Helpful Links

• Inhibition of metastasis and angiogenesis in Hep-2 cells by wheatgrass extract - an in vitro and in silico approach
• Effect of Wheatgrass on DNA damage, oxidative stress index and histological findings in Diabetic Rats

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2023
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperglycemia; Hypertension; Birth Weight
• Other Study ID Numbers: swalife001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will be sharing the Protocol of the study and the execution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No