Randomized clinical trial: how a plant called Eclipta prostrata (commonly known as false daisy) can help people with Obesity

Randomized clinical trial: effect of the herbal medicine from Eclipta prostrata (L.) L. (Asteraceae) on phase angle in adults with grade I Obesity

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-5wy4vhx

Enrollment

Unknown

Registered

2023-07-28

Start date

2023-10-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition disorders

Interventions

This is a phase II placebo controlled randomized clinical trial, triple-blind, with two parallel arms allocated in a 1:1 ratio. A total of 74 research participants with grade I obesity will be randoml

B01.875.800.575.912.250.100.337

N02.421.726.407.579.650.500

MT3.465.763

Eligibility

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: Adults of both genders; aged 18 to 59; with grade I obesity; monitored in primary healthcare unities

Exclusion criteria

Exclusion criteria: Participants with comorbidities characterized by low-grade chronic inflammation, except for those associated with obesity and metabolic syndrome; history of chronic use of corticosteroids, immunosuppressants, or nonsteroidal anti-inflammatory drugs; health conditions that may interfere with the parameters measured by bioelectrical impedance analysis, such as edema, chronic kidney disease, end-stage organ failure, or amputated limbs; implanted cardiac devices; chronic diarrhea; ethical restrictions that prevent proper consent for study participation; women who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
We expect to observe an increase of 0.28º in the phase angle from bioelectrical impedance analysis in the intervention group compared to the placebo group	—

Secondary

Measure	Time frame
We expect to find an inverse correlation between the variation of the phase angle and serum C-reactive protein;We expect to observe a statistically significant improvement in clinical and laboratory parameters associated with low-grade chronic inflammation, such as a reduction in fasting plasma glucose, blood pressure, total serum cholesterol, triglycerides, and LDL cholesterol, as well as an increase in serum HDL cholesterol;We expect to observe a statistically significant improvement in the score results of the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Depression, Anxiety and Stress Scales - 21 (DASS-21), and Binge Eating Scale;We expect to observe a reduction in the hepatorenal echointensity gradient measured by histogram analysis of ultrasound images of the hepatic and right renal parenchyma	—

Measure

Time frame

We expect to find an inverse correlation between the variation of the phase angle and serum C-reactive protein;We expect to observe a statistically significant improvement in clinical and laboratory parameters associated with low-grade chronic inflammation, such as a reduction in fasting plasma glucose, blood pressure, total serum cholesterol, triglycerides, and LDL cholesterol, as well as an increase in serum HDL cholesterol;We expect to observe a statistically significant improvement in the score results of the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Depression, Anxiety and Stress Scales - 21 (DASS-21), and Binge Eating Scale;We expect to observe a reduction in the hepatorenal echointensity gradient measured by histogram analysis of ultrasound images of the hepatic and right renal parenchyma

—

Countries

Brazil

Contacts

Public ContactGustavo Moura

Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

gsplmoura@usp.br+551636022366

Outcome results

None listed

Source: REBEC (via WHO ICTRP)