MeSHNCT06520501
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Glucose of Obese Patients
A study testing Herbal Medicine Sambiloto, Brisk Walking and Brisk Walking and Herbal Medicine Sambiloto in people with MeSH, run by Universitas Palangka Raya.
Trial summary
Problem Formulation 1. Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers? 2. Does brisk walking affect blood glucose levels in obese sufferers? 3. Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers? 4. 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?
- Herbal Medicine Sambiloto, Brisk Walking and Brisk Walking and Herbal Medicine Sambiloto
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2024to 1 Oct 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
- Willing to be a respondent with informed consent
- Obesity sufferers in the Jekan Raya District area
- Have a BMI ≥ 25 kg/m2 (Obesity I)
- Adult age (19-39 years)
Who cannot join
- Not being present or out of town during the research
- Unable to continue research due to serious illness or death
- Withdraw while participating in the research
- Have a history of drug allergies
- Experiencing decreased consciousness
- Experiencing an extremity injury
Show all 9Show fewer
- Have a history of cardiovascular disease, kidney disease or stomach ulcers
- Have a history of bloody stools
- Are pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Problem Formulation
- Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers?
- Does brisk walking affect blood glucose levels in obese sufferers?
- Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers?
- Is there a difference in the effectiveness between herbal bitter and brisk walking and the combination on blood glucose levels in obese sufferers?
Read more
Research Objectives
General Objectives :
The general aim of this research is to determine the difference in effectiveness between the herbal medicine Sambiloto and brisk walking as well as the combination on the blood glucose levels of obese sufferers.
Specific Objective :
- Knowing the effect of herbal medicine Sambiloto on blood glucose in obese sufferers.
- Knowing the effect of brisk walking on blood glucose in obese sufferers.
- To determine the effect of the combination of herbal medicine Sambiloto and brisk walking on blood glucose levels in obese sufferers.
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 herbal medicine sambiloto, 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
- Herbal Medicine Sambiloto, Brisk Walking, Brisk Walking and Herbal Medicine Sambiloto
- 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.
Herbal Medicine SambilotoDietary 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 WalkingBehavioural
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.
Brisk Walking and Herbal Medicine SambilotoCombination product
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 | 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. Receives: Behavioral: Brisk Walking |
| Herbal Medicine Sambiloto | 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: Herbal Medicine Sambiloto |
| 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.
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: Combination Product: Brisk Walking and Herbal Medicine Sambiloto |
| Control Obese | No intervention | Obese with no intervention |
| Control Normal | No intervention | Normal with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Differences
Difference in blood glucose before and after treatment
Measured: 7 consecutive day
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 start4 Sep 2024 (estimated)
- Primary completion14 Sep 2024 (estimated)
- Study completion1 Oct 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
- Investigators
- Agnes Veronica Agustin, Principal investigator, Universitas Palangka Raya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520501
- Sponsor's protocol ID
- 2504031946
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2024
- Last updated
- 19 Sep 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 19 Sep 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 Glucose of Obese Patients
- ClinicalTrials.gov ID
- NCT06520501
- Acronym / sponsor ID
- 2504031946
- 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
- 4 Sep 2024 (estimated)
- Primary completion
- 14 Sep 2024 (estimated)
- Study completion
- 1 Oct 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
- Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers?
- Does brisk walking affect blood glucose levels in obese sufferers?
- Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers?
- Is there a difference in the effectiveness between herbal bitter and brisk walking and the combination on blood glucose levels in obese sufferers?
Research Objectives
General Objectives :
The general aim of this research is to determine the difference in effectiveness between the herbal medicine Sambiloto and brisk walking as well as the combination on the blood glucose levels of obese sufferers.
Specific Objective :
- Knowing the effect of herbal medicine Sambiloto on blood glucose in obese sufferers.
- Knowing the effect of brisk walking on blood glucose in obese sufferers.
- To determine the effect of the combination of herbal medicine Sambiloto and brisk walking on blood glucose levels in obese sufferers.
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 herbal medicine sambiloto, 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 | Experimental | Behavioral: Brisk WalkingModerate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute. |
| Herbal Medicine Sambiloto | Experimental | Dietary Supplement: Herbal Medicine SambilotoJamu 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 | Combination Product: Brisk Walking and Herbal Medicine SambilotoModerate 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. |
| Control Obese | No intervention | –Obese with no intervention |
| Control 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 (4 listed)
- Willing to be a respondent with informed consent
- Obesity sufferers in the Jekan Raya District area
- Have a BMI ≥ 25 kg/m2 (Obesity I)
- Adult age (19-39 years)
Key exclusion criteria (9 listed)
- Not being present or out of town during the research
- Unable to continue research due to serious illness or death
- Withdraw while participating in the research
- Have a history of drug allergies
- Experiencing decreased consciousness
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 |
|---|---|---|
| Herbal Medicine SambilotoJamu 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 | Herbal Medicine Sambiloto |
| Brisk WalkingModerate 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 |
| Brisk Walking and Herbal Medicine SambilotoModerate 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 | Combination product | Combination |
Primary outcome
Blood Glucose Differences
Time frame: 7 consecutive day
Difference in blood glucose 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 19 Sep 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.
Agnes Veronica Agustin principal investigator
Universitas Palangka Raya
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Medicine Sambiloto, Brisk Walking and Brisk Walking and Herbal Medicine Sambiloto in people with MeSH, run by Universitas Palangka Raya.
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 4 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Agnes Veronica Agustin (+6285249596617, agnesveronicaagustini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Differences (time frame: 7 consecutive day). 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 19 Sep 2024.