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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05851040
• Other study ID #: swalife001
• Status: Not yet recruiting
• Start date: May 10, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2023
• Source: Swalife Biotech
• Contact: Pravin Badhe, PhD
• Phone: 7038248513
• Email: drpravinbadhe[@]swalifebiotech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Blood Pressure, High
• Blood Sugar; High
• Hyperglycemia
• Hypertension
• Smoking

Intervention

Other:
• Observation study
Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug

Locations

Country	Name	City	State
India	Sinhgad college of Pharmacy	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Swalife Biotech

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Effect of wheat grass and tulsi in combination on weight	Weight is measure in Kg every four week.	Every four week till 6 months
Primary	Effect of wheat grass and tulsi in combination on smoking	questionnaire assesment for "Smoking habits"	Every four week till 6 months
Secondary	Effect of wheat grass and tulsi separately on blood pressure	Blood Pressure measured in mmHg every four week.	Every four week till 6 months
Secondary	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
Secondary	Effect of wheat grass and tulsi separately on weight	Weight is measure in Kg every four week.	Every four week till 6 months
Secondary	Effect of wheat grass and tulsi separately on smoking	questionnaire assesment for "Smoking habits"	Every four week till 6 months
Secondary	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
Secondary	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
Secondary	Effect of wheat grass, tulsi and allopathic drug on weight	Weight is measure in Kg every four week.	Every four week till 6 months
Secondary	Effect of wheat grass, tulsi and allopathic drug on smoking	questionnaire assesment for "Smoking habits"	Every four week till 6 months

External Links

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