A clinical trial of Hochuekkito for patients with Long COVID

JRCT ID: jRCTs061240010

Registered date:15/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Long COVID
• Date of first enrollment: 15/05/2024
• Target sample size: 156
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Fatigue Assessment Scale

Secondary Outcome

1. Quality of life scale: Euro-QOL
2. Self-rating depression scale (SDS)
3. Anxiety scale: STAI from JYZ
4. Fatigue level assessed by performance status
5. Short Qi deficiency scale
6.Long COVID associated symptoms
7.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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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, poorly controlled diabetes (blood glucose level shows more than 300 mg/dL at any time))
Hypoglycemia (serum K = 3.2 mEq/L or less), hyponatremia (serum Na = 125mmol/L or less), hypernatraemia (serum Na = 150 mmol/L or less), hypercalcemia (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

• Primary Sponsor: Tokumasu Kazuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development