MeSHNCT06520527
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients
A study testing Andrographis paniculata, Brisk Walking Exercise and Combination in people with MeSH, run by Universitas Palangka Raya at 1 site in Indonesia.
Trial summary
Problem Formulation 1. Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District? 2. Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District? 3. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- MeSH
- What is being tested?
- Andrographis paniculata, Brisk Walking Exercise and Combination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jul 2024to Sep 2024
- Phase
- Interventional
- 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 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) ≥ 25 kg/m2 (Obesity 1) Blood pressure does not exceed 139/89 mmHg (High Normal) Adult age (19-39 years) Willing to be a respondent with informed consent Have health insurance coverage
Who cannot join
- Not in place or out of town during the study Experiencing illness that cannot carry out research interventions and data collection Resign during the study Routine exercise (Exercise every day less than 6000 steps). Taking anti-hypertensive drugs regularly Pregnant and breastfeeding mothers Routinely consume jamu sambiloto History of bone and joint disease that prevents physical activity History of cardiovascular or kidney disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Sports Facilities
Palangkaraya, Central Kalimantan, 73111
Muhammad Revo Andaluzio Sazly Revo Sazly, +6281808154654, revosazly1@gmail.com
Muhammad Revo Andaluzio Sazly Revo Sazly
About this study
Problem Formulation
- Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
- Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?
- Is there an effect of brisk walking exercise and combined administration of jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
- Is there a difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in Jekan Raya District?
Read more
Research Objectives
General Objective:
This study aims to determine the difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise on blood pressure in obese people in Jekan Raya District.
Specific Objectives:
This study specifically aims to:
- Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).
- Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.
- Knowing the effect before and after giving Jamu Sambiloto (Andrographis paniculata) and Brisk Walking Exercise on Blood Pressure in obese people in Jekan Raya District.
Read the detailed description
This type of research uses the Quasi Experimental method type Non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. The intervention group is divided into two groups, namely the group given the sambiloto herbal medicine, and the group given the Brisk Walking Exercise treatment. Quasi-experimental research design with research design in the form of two group pre test and post test design.
- Conditions
- MeSH
- Being tested
- Andrographis paniculata, Brisk Walking Exercise, Combination
- Keywords
- Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrographis paniculataDietary supplement
Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.
Brisk Walking ExerciseBehavioural
Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.
CombinationOther
Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.
Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Brisk Walking Exercise | Experimental | Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a Receives: Behavioral: Brisk Walking Exercise |
| Andrographis Paniculata | Experimental | Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. Receives: Dietary Supplement: Andrographis paniculata |
| Combination | Experimental | Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a
Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. Receives: Other: Combination |
| Control | No intervention | Obese with no intervention |
| Normal | No intervention | Normal with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systole and Diastole Differences
Difference in Systole and Diastole before and after treatment
Measured: 7 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start21 Jul 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeSHStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Palangka Raya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Veronica Agustin, Universitas Palangka Raya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520527
- Sponsor's protocol ID
- 2504031945
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients
- ClinicalTrials.gov ID
- NCT06520527
- Acronym / sponsor ID
- 2504031945
- Conditions
- MeSH
- Keywords
- Obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas Palangka RayaUniversity, hospital or other
- Study start
- 21 Jul 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Jul 2024 (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.
Problem Formulation
- Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
- Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?
- Is there an effect of brisk walking exercise and combined administration of jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
- Is there a difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in Jekan Raya District?
Research Objectives
General Objective:
This study aims to determine the difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise on blood pressure in obese people in Jekan Raya District.
Specific Objectives:
This study specifically aims to:
- Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).
- Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.
- Knowing the effect before and after giving Jamu Sambiloto (Andrographis paniculata) and Brisk Walking Exercise on Blood Pressure in obese people in Jekan Raya District.
Detailed description
This type of research uses the Quasi Experimental method type Non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. The intervention group is divided into two groups, namely the group given the sambiloto herbal medicine, and the group given the Brisk Walking Exercise treatment. Quasi-experimental research design with research design in the form of two group pre test and post test design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Brisk Walking Exercise | Experimental | Behavioral: Brisk Walking ExerciseModerate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a |
| Andrographis Paniculata | Experimental | Dietary Supplement: Andrographis paniculataJamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. |
| Combination | Experimental | Other: CombinationModerate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. |
| Control | No intervention | –Obese with no intervention |
| Normal | No intervention | –Normal with no intervention |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) ≥ 25 kg/m2 (Obesity 1) Blood pressure does not exceed 139/89 mmHg (High Normal) Adult age (19-39 years) Willing to be a respondent with informed consent Have health insurance coverage
Key exclusion criteria (1 listed)
- Not in place or out of town during the study Experiencing illness that cannot carry out research interventions and data collection Resign during the study Routine exercise (Exercise every day less than 6000 steps). Taking anti-hypertensive drugs regularly Pregnant and breastfeeding mothers Routinely consume jamu sambiloto History of bone and joint disease that prevents physical activity History of cardiovascular or kidney disease
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 |
|---|---|---|
| Andrographis paniculataJamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. | Dietary supplement | Andrographis Paniculata |
| Brisk Walking ExerciseModerate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute. | Behavioural | Brisk Walking Exercise |
| CombinationModerate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute. Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days. | Other | Combination |
Primary outcome
Systole and Diastole Differences
Time frame: 7 consecutive days
Difference in Systole and Diastole before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Andrographis paniculata, Brisk Walking Exercise and Combination in people with MeSH, run by Universitas Palangka Raya at 1 site in Indonesia.
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 1 inclusion and 1 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 25 Jul 2024. 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 Indonesia. 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 Muhammad Revo Andaluzio Sazly Revo Sazly (+6281808154654, revosazly1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systole and Diastole Differences (time frame: 7 consecutive days). 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 25 Jul 2024.