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

Sponsor
Swalife Biotech (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05851040
Collaborator
(none)
100
1
5.7
17.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Observation of Wheatgrass and Tulsi Formulation or Its Effect With Allopathic Drugs
Anticipated Study Start Date :
May 10, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Effect of wheat grass and tulsi in combination on blood pressure [Every four week till 6 months]

    Blood Pressure measured in mmHg every four week.

  2. Effect of wheat grass and tulsi in combination on blood sugar [Every four week till 6 months]

    Blood Sugar measured in mmol/L every four week

  3. Effect of wheat grass and tulsi in combination on weight [Every four week till 6 months]

    Weight is measure in Kg every four week.

  4. Effect of wheat grass and tulsi in combination on smoking [Every four week till 6 months]

    questionnaire assesment for "Smoking habits"

Secondary Outcome Measures

  1. Effect of wheat grass and tulsi separately on blood pressure [Every four week till 6 months]

    Blood Pressure measured in mmHg every four week.

  2. Effect of wheat grass and tulsi separately on blood sugar [Every four week till 6 months]

    Blood Sugar measured in mmol/L every four week.

  3. Effect of wheat grass and tulsi separately on weight [Every four week till 6 months]

    Weight is measure in Kg every four week.

  4. Effect of wheat grass and tulsi separately on smoking [Every four week till 6 months]

    questionnaire assesment for "Smoking habits"

  5. Effect of wheat grass, tulsi and allopathic drug on blood pressure [Every four week till 6 months]

    Blood Pressure measured in mmHg every four week.

  6. Effect of wheat grass, tulsi and allopathic drug on blood sugar [Every four week till 6 months]

    Blood Sugar measured in mmol/L every four week.

  7. Effect of wheat grass, tulsi and allopathic drug on weight [Every four week till 6 months]

    Weight is measure in Kg every four week.

  8. Effect of wheat grass, tulsi and allopathic drug on smoking [Every four week till 6 months]

    questionnaire assesment for "Smoking habits"

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sinhgad college of Pharmacy Pune Maharashtra India 411041

Sponsors and Collaborators

  • Swalife Biotech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Swalife Biotech
ClinicalTrials.gov Identifier:
NCT05851040
Other Study ID Numbers:
  • swalife001
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023