Study of Hachimijiogan for patients with "jinkyo"

JRCT ID: jRCTs031240056

Registered date:26/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: jinkyo
• Date of first enrollment: 12/06/2024
• Target sample size: 12
• Study type: Interventional
• Intervention(s): EK-700 dosage should start at 60 pills per day, divided into three doses and administered orally before each meal. Continuous administration for 8 weeks.

Outcome(s)

• Primary Outcome: Change from baseline to 8 weeks in jinkyo score (total)

Secondary Outcome

1.Change from baseline to 4 weeks in jinkyo score (total).
2.Change from baseline to 4 and 8 weeks for the following items;
a)Lower body muscle mass (lean body mass).
b)Advanced Glycation End Products
c)Serum dehydroepiandrosterone-sulfate
d)HbA1c
e)GA
f)Body Mass Index
3.The following blood test items
a)Red blood cell count
b)Haemoglobin level
c)Haematocrit level
d)White blood cell count
e)White blood cell fractions [neutrophils, lymphocytes, monocytes, eosinophils, basophils].
f)Platelet count
4.Blood biochemical tests for the following
a)Aspartate aminotransferase
b)Alanine aminotransferase
c)Alkaline phosphatase
d)Lactate dehydrogenase
e)Gamma-glutamyltransferase
f)Total bilirubin
g)Total protein
h)Albumin
i)Urea nitrogen
j)Creatinine
k)Cystatin C
l)Total cholesterol
m)Triglycerides
n)C-reactive protein
o)Electrolytes [sodium, potassium, chlorine, calcium, magnesium].

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with various symptoms of jinkyo.
2. Patients with one or more symptoms corresponding to the indications for the study drug.
(corresponding to the indications:Lower limb pain, hip pain, numbness, blurred vision, itching, dysuria, frequent urination, swelling)
3.Patients aged 65 years and over on the date consent is obtained.
4.Patients who are judged by the doctor to have obtained written consent from the individual, to comply with the compliance requirements during participation in the research, to undergo the medical examination and tests stipulated in the research protocol, and to be able to report symptoms and other information.

Exclude criteria

1.Patients with a confirmed or suspected active malignancy or with a confirmed malignancy within 5 years prior to screening.
2.Patients with concomitant diabetes mellitus and patients receiving SGLT2 inhibitors, including for conditions other than diabetes.
3.Patients with a history of gastrectomy.
4.Patients with gastrointestinal disorders with unstable symptoms.
5.Patients with a history of hypersensitivity to study drug components.
6.Patients with a history of taking herbal preparations within 2 weeks prior to the date of enrolment.
7.Patients with implanted medical devices such as cardiac pacemakers.
8.Patients who are using oral steroids, inhalants, injections or topical and who have used them within the last three months.
9.Patients deemed ineligible at the discretion of the doctor.

Related Information

• Primary Sponsor: Hirasaki Yoshiro
• Secondary Sponsor: Namiki Takao
• Source(s) of Monetary Support: Kracie, Ltd.