NIPH Clinical Trials Search

JRCT ID: jRCTs061240010

Registered date:15/05/2024

A clinical trial of Hochuekkito for patients with Long COVID

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedLong COVID
Date of first enrollment15/05/2024
Target sample size156
Countries of recruitment
Study typeInterventional
Intervention(s)Tsumura Hochuekkito Extract Granules 2.5 g or Placebo Granules 2.5 g should be administered orally three times daily before or between meals. Dosage and frequency of administration may be adjusted according to age, weight and symptoms. The dose should be administered for 42 consecutive days.


Primary OutcomeFatigue Assessment Scale
Secondary Outcome1. Quality of life scale: Euro-QOL 2. Self-rating depression scale (SDS) 3. Anxiety scale: STAI from JYZ 4. Long COVID associated symptoms 5. Adverse events (side effects) attributable to Hochuekkito from the start of the intervention to 6 weeks post-intervention.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1. patients with COVID-19 confirmed by PCR or other tests 2. outpatients (patients with mild COVID-19 disease) 3. patients with COVID-19 onset of more than 4 weeks but less than 24 weeks 4. those with a FAS (Fatigue Assessment Scale) score of 22 or more 5. who are able to complete the questionnaire online, e.g. by smartphone or computer 6. patients aged 18 years or older (regardless of sex) at the time consent is obtained 7. patients who have given a full explanation of their participation in the study, and who have given their free and voluntary written consent based on a full understanding of the study. For *1, 2 and 3, patients who have been affected by COVID-19 more than once, the criteria are for the COVID-19 in which the sequelae appeared.
Exclude criteria1. patients with any of the following diseases or laboratory abnormalities that cause general malaise on examination at the time of admission Active infectious diseases (active pulmonary tuberculosis, active infections such as hepatitis B and C viruses) Endocrine and metabolic disorders (adrenal insufficiency, thyroid dysfunction, diabetes mellitus) Hypoklycaemia (serum K = 3.2 mEq/L or less), hyponatraemia (serum Na = 125mmol/L or less), hypernatraemia (serum Na = 150 mmol/L or less), hypercalcaemia (corrected serum Ca = 12 mg/dL or more), Severe anemia (Hb 9g/dL or less: women, Hb10g/dL or less: men) 2. patients who had taken Chinese herbal medicines up to 4 weeks prior to inclusion in the study 3. patients with a history of adverse reactions such as allergy to Ho-Chung Ki-To 4. women who are pregnant or may become pregnant 5. patients with a history or comorbidities such as myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia, rheumatic diseases, adrenal insufficiency or growth hormone deficiency that may cause chronic fatigue 6. patients who, at the time of presentation, are attending a psychiatric department and are being treated for an ICD-10 (International Classification of Diseases) Chapter 5 mental and behavioural disorder (see separate document: ICD-10 (International Classification of Diseases) Chapter 5 Mental and Behavioural Disorders) 7. other patients who are judged to be inappropriate as research subjects by the principal investigator and the sub-investigators.

Related Information


Public contact
Name Kazuki Tokumasu
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7342
Affiliation Okayama University Hospital
Scientific contact
Name Kazuki Tokumasu
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7342
Affiliation Okayama University Hospital