Clinical trial NCT05851040: Observe the Effect of Wheatgrass and Tulsi Formulation or Individuals Taken With Other Allopathic Drugs
Official title: Observation of Wheatgrass and Tulsi Formulation or Its Effect With Allopathic Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure, High
Blood Sugar; High
Weight, Birth
Smoking
Lead sponsor: Swalife Biotech
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of wheat grass and tulsi in combination on blood pressure
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi in combination on blood sugar
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi in combination on weight
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi in combination on smoking
timeFrame: Every four week till 6 months
Secondary outcomes:
measure: Effect of wheat grass and tulsi separately on blood pressure
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi separately on blood sugar
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi separately on weight
timeFrame: Every four week till 6 months
measure: Effect of wheat grass and tulsi separately on smoking
timeFrame: Every four week till 6 months
measure: Effect of wheat grass, tulsi and allopathic drug on blood pressure
timeFrame: Every four week till 6 months
measure: Effect of wheat grass, tulsi and allopathic drug on blood sugar
timeFrame: Every four week till 6 months
measure: Effect of wheat grass, tulsi and allopathic drug on weight
timeFrame: Every four week till 6 months
measure: Effect of wheat grass, tulsi and allopathic drug on smoking
timeFrame: Every four week till 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Sinhgad college of Pharmacy
state: Maharashtra
Study officials:
References: