NCT06520527

Brief Summary

Problem Formulation

  1. 1.Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?
  2. 2.Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?
  3. 3.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?
  4. 4.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?
  5. 5.Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).
  6. 6.Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.
  7. 7.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

11 days

First QC Date

July 21, 2024

Last Update Submit

July 21, 2024

Conditions

Keywords

Obese

Outcome Measures

Primary Outcomes (1)

  • Systole and Diastole Differences

    Difference in Systole and Diastole before and after treatment

    7 consecutive days

Study Arms (5)

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

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.

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.

Other: Combination

Control

NO INTERVENTION

Obese with no intervention

Normal

NO INTERVENTION

Normal with no intervention

Interventions

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.

Andrographis Paniculata

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 Exercise

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.

Combination

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Facilities

Palangkaraya, Central Kalimantan, 73111, Indonesia

Location

MeSH Terms

Conditions

Obesity

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Muhammad Revo Andaluzio Sazly Revo Sazly

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Agnes Veronica Agustin

Study Record Dates

First Submitted

July 21, 2024

First Posted

July 25, 2024

Study Start

July 21, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations