Blood Pressure, HighNCT05851040
Observe the Effect of Wheatgrass and Tulsi Formulation or Individuals Taken With Other Allopathic Drugs
An observational study of Blood Pressure, High and Blood Sugar; High, run by Swalife Biotech at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Blood Pressure, High, Blood Sugar; High, Weight, Birth
- What is being tested?
- Observation study
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 10 May 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of age group 30 to 65 is targeted who have chronic disease and are taking wheat grass and tulsi formulation.
Who may be able to join
- Patients who are having a chronic disease and taking formulation wheat grass and tulsi.
- Patients who are taking wheatgrass and tulsi separately.
- Patients who are taking wheatgrass, tulsi and regular medicine. -
Who cannot join
- Patients below 30 years.
- Patients who are having a chronic disease but not using formulations of wheatgrass and tulsi.
- Patients who are not taking wheatgrass and tulsi separately.
Trial locations and contacts
1 site in 1 country.
India1 site
Sinhgad college of Pharmacy
Pune, Maharashtra, 411041
Pravin Badhe, PhD, 7038248513 ext. 91, drpravinbadhe@swalifebiotech.com
Pravin Badhe, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Pressure, High, Blood Sugar; High, Weight, Birth, Smoking
- Being tested
- Observation study
- Medical subject headings
- Hypertension, Hyperglycemia, Birth Weight, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation studyOther
Looking to find the role of wheatgrass and tulsi give separately or with allopathic drug
| Study group | Role | What they receive |
|---|---|---|
| With Wheatgrass, tulsi formulation | People using Wheatgrass and Tulsi formulation or individual Receives: Other: Observation study | |
| With Wheatgrass, tulsi formulation and allopathic drugs | People using Wheatgrass and Tulsi formulations or individuals with chronic disease medicine. Receives: Other: Observation study | |
| Same age group not using any medication | Not described Receives: Other: Observation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of wheat grass and tulsi in combination on blood pressure
Blood Pressure measured in mmHg every four week.
Measured: 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
Measured: Every four week till 6 months
Effect of wheat grass and tulsi in combination on weight
Weight is measure in Kg every four week.
Measured: Every four week till 6 months
Effect of wheat grass and tulsi in combination on smoking
questionnaire assesment for "Smoking habits"
Measured: Every four week till 6 months
Secondary outcomes (8)
Effect of wheat grass and tulsi separately on blood pressure
Blood Pressure measured in mmHg every four week.
Measured: 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.
Measured: Every four week till 6 months
Effect of wheat grass and tulsi separately on weight
Weight is measure in Kg every four week.
Measured: Every four week till 6 months
Effect of wheat grass and tulsi separately on smoking
questionnaire assesment for "Smoking habits"
Measured: 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.
Measured: 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.
Measured: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on weight
Weight is measure in Kg every four week.
Measured: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on smoking
questionnaire assesment for "Smoking habits"
Measured: Every four week till 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 May 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure, HighStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swalife Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851040
- Sponsor's protocol ID
- swalife001
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will be sharing the Protocol of the study and the execution.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Wheatgrass and Tulsi Formulation or Its Effect With Allopathic Drugs
- ClinicalTrials.gov ID
- NCT05851040
- Acronym / sponsor ID
- swalife001
- Conditions
- Blood Pressure, High, Blood Sugar; High, Weight, Birth, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Swalife BiotechIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| With Wheatgrass, tulsi formulation | – | Other: Observation studyPeople using Wheatgrass and Tulsi formulation or individual |
| With Wheatgrass, tulsi formulation and allopathic drugs | – | Other: Observation studyPeople using Wheatgrass and Tulsi formulations or individuals with chronic disease medicine. |
| Same age group not using any medication | – | Other: Observation study |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of age group 30 to 65 is targeted who have chronic disease and are taking wheat grass and tulsi formulation.
Key inclusion criteria (3 listed)
- Patients who are having a chronic disease and taking formulation wheat grass and tulsi.
- Patients who are taking wheatgrass and tulsi separately.
- Patients who are taking wheatgrass, tulsi and regular medicine. -
Key exclusion criteria (3 listed)
- Patients below 30 years.
- Patients who are having a chronic disease but not using formulations of wheatgrass and tulsi.
- Patients who are not taking wheatgrass and tulsi separately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation studyLooking to find the role of wheatgrass and tulsi give separately or with allopathic drug | Other | Same age group not using any medication, With Wheatgrass, tulsi formulation, With Wheatgrass, tulsi formulation and allopathic drugs |
Primary outcome
Effect of wheat grass and tulsi in combination on blood pressure
Time frame: Every four week till 6 months
Blood Pressure measured in mmHg every four week.
Effect of wheat grass and tulsi in combination on blood sugar
Time frame: Every four week till 6 months
Blood Sugar measured in mmol/L every four week
Effect of wheat grass and tulsi in combination on weight
Time frame: Every four week till 6 months
Weight is measure in Kg every four week.
Effect of wheat grass and tulsi in combination on smoking
Time frame: Every four week till 6 months
questionnaire assesment for "Smoking habits"
8 secondary outcomes
Effect of wheat grass and tulsi separately on blood pressure
Time frame: Every four week till 6 months
Effect of wheat grass and tulsi separately on blood sugar
Time frame: Every four week till 6 months
Effect of wheat grass and tulsi separately on weight
Time frame: Every four week till 6 months
Effect of wheat grass and tulsi separately on smoking
Time frame: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on blood pressure
Time frame: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on blood sugar
Time frame: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on weight
Time frame: Every four week till 6 months
Effect of wheat grass, tulsi and allopathic drug on smoking
Time frame: Every four week till 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided. We will be sharing the Protocol of the study and the execution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, High and Blood Sugar; High, run by Swalife Biotech at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pravin Badhe, PhD (7038248513 ext. 91, drpravinbadhe@swalifebiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of wheat grass and tulsi in combination on blood pressure (time frame: Every four week till 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.