Study on the Effects of Rikkunshito on Functional Dyspepsia in Primary Care Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Rikkunshito (also known by its code name TJ-43) on a condition known as Functional Dyspepsia. Functional Dyspepsia is a common digestive disorder that causes discomfort or pain in the upper abdomen, often after eating. The trial aims to understand how Rikkunshito can help alleviate the symptoms associated with this condition.

Participants in the study will receive either Rikkunshito or a matching placebo, which looks like the treatment but does not contain the active substance. The treatment is administered in the form of granules taken orally. The study will last for a period of up to 16 weeks, during which participants will be monitored to assess the impact of the treatment on their symptoms. The primary focus is to evaluate the therapeutic effect of Rikkunshito on the symptoms of Functional Dyspepsia.

Throughout the study, participants will be asked to keep a daily diary using the Leuven Postprandial Distress Scale (LPDS) to record their symptoms. This will help researchers determine the effectiveness of Rikkunshito compared to the placebo. Additionally, the study will explore how the treatment affects other aspects such as quality of life, anxiety, and depression, using various questionnaires. The goal is to gather comprehensive data on the potential benefits of Rikkunshito for individuals with Functional Dyspepsia.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of symptoms related to functional dyspepsia and ensuring no structural disease is present.

Eligibility is determined based on criteria such as age (18 years or older), a new diagnosis of functional dyspepsia, and the ability to comply with study requirements.

2 run-in period

A two-week run-in period is required, during which symptoms are monitored using the Leuven Postprandial Distress Scale (LPDS) diary.

This period helps establish a baseline for symptoms like postprandial fullness and early satiation.

3 randomization and treatment

Participants are randomly assigned to receive either Rikkunshito or a matching placebo. Both are administered in the form of granules taken orally.

The treatment lasts for eight weeks, with daily monitoring of symptoms using the LPDS diary.

4 symptom evaluation

Throughout the treatment, symptoms are evaluated using the LPDS diary to assess the therapeutic effect of Rikkunshito compared to placebo.

A responder is identified by a clinically relevant improvement in the LPDS score.

5 secondary assessments

Additional assessments include the effect of Rikkunshito on duodenal mucosal parameters, quality of life, and psychological factors such as depression and anxiety.

These are evaluated using questionnaires like the PAGI-Qol and PHQ.

6 end of study

The study concludes with a final evaluation of symptoms and overall health.

The primary endpoint is to determine the therapeutic effect of Rikkunshito on functional dyspepsia symptoms.

Who Can Join the Study?

Participants must provide voluntary written consent before any screening procedures begin.
Participants should be able to understand and follow the study requirements.
Participants must use highly effective birth control methods. These methods have a very low chance of failure (less than 1% per year) when used correctly. Examples include implants, injections, combined oral contraceptives, certain IUDs, complete sexual abstinence, or having a partner who has had a vasectomy.
Both males and females can participate.
Participants must be 18 years old or older.
Participants should have a new diagnosis of Functional Dyspepsia (FD). This is determined by the Rome Criteria, which includes symptoms like bothersome fullness after eating, feeling full quickly, pain in the upper stomach area, or burning in the upper stomach area. There should be no structural disease found that explains these symptoms. These criteria should have been met for the last 3 months, with symptoms starting at least 6 months before diagnosis.
Participants should have moderate bothersome fullness after eating or feeling full quickly for 2 to 5 days a week. This will be evaluated using a diary during a 2-week period before the study starts.

Who Cannot Join the Study?

Patients who are not experiencing Functional Dyspepsia. This is a condition where people have stomach discomfort or pain without a clear cause.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning those who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	02.12.2024

Trial locations

Investigated drugs:

RIKKUNSHITO

Rikkunshito (TJ-43) is a traditional Japanese herbal medicine used in this trial to help manage symptoms of functional dyspepsia, a condition characterized by discomfort or pain in the upper abdomen. The trial aims to evaluate how effective Rikkunshito is in reducing these symptoms in patients who have been recruited from primary care settings.

Functional Dyspepsia – Functional dyspepsia is a common digestive disorder characterized by persistent or recurring pain or discomfort in the upper abdomen. It often involves symptoms such as bloating, nausea, and feeling full quickly after starting to eat. Unlike other digestive conditions, functional dyspepsia does not have an identifiable structural or biochemical cause. The symptoms can vary in intensity and may be triggered by eating certain foods or stress. It is a chronic condition that can fluctuate over time, with periods of symptom relief and exacerbation. The exact cause is not well understood, but it may involve abnormal motility or sensitivity of the stomach.

Trial ID:

2024-515756-20-00

NCT ID:

NCT06482671

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Rikkunshito on Functional Dyspepsia in Primary Care Patients

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