NCT06520501

Brief Summary

Problem Formulation

  1. 1.Does herbal medicine sambiloto affect the blood glucose levels of obese sufferers?
  2. 2.Does brisk walking affect blood glucose levels in obese sufferers?
  3. 3.Does the combination of bitter herbal medicine and brisk walking have an effect on blood glucose levels in obese sufferers?
  4. 4.Is there a difference in the effectiveness between herbal bitter and brisk walking and the combination on blood glucose levels in obese sufferers?
  5. 5.Knowing the effect of herbal medicine Sambiloto on blood glucose in obese sufferers.
  6. 6.Knowing the effect of brisk walking on blood glucose in obese sufferers.
  7. 7.To determine the effect of the combination of herbal medicine Sambiloto and brisk walking on blood glucose levels in obese sufferers.

Trial Health

35
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 Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 days

First QC Date

July 21, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

Obese

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose Differences

    Difference in blood glucose before and after treatment

    7 consecutive day

Study Arms (5)

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.

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.

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.

Combination Product: Brisk Walking and Herbal Medicine Sambiloto

Control Obese

NO INTERVENTION

Obese with no intervention

Control Normal

NO INTERVENTION

Normal with no intervention

Interventions

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.

Herbal Medicine Sambiloto
Brisk WalkingBEHAVIORAL

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

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:

  • 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)

You may not qualify if:

  • 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
  • Have a history of cardiovascular disease, kidney disease or stomach ulcers
  • Have a history of bloody stools
  • Are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Agnes Veronica Agustin

    Universitas Palangka Raya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Ketua Komite Etik

Study Record Dates

First Submitted

July 21, 2024

First Posted

July 25, 2024

Study Start

September 4, 2024

Primary Completion

September 14, 2024

Study Completion

October 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09