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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05851040
Other study ID # swalife001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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