Treatment of chronic fatigue syndrome by a Chinese herbal formula Sijunzi decoction

Sijunzi decoction for chronic fatigue syndrome with spleen deficiency pattern: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23930966

Enrollment

212

Registered

2019-05-28

Start date

2019-07-31

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Chronic fatigue syndrome with spleen deficiency pattern Nervous System Diseases Postviral fatigue syndrome

Interventions

Participants will be allocated to experimental or placebo arm based on the random number generated by SPSS 22.0 for Windows. Participants will be required to take the medicine twice daily for two cons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18-80 years old, both genders 2. Meet the American CDC diagnostic criteria of chronic fatigue syndrome 3. Meet the TCM criteria of spleen deficiency pattern 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Combine with mental disorders 2. Secondary fatigue due to medications or other diseases 3. Combine with severe cardiovascular diseases, cerebrovascular diseases, hepatic diseases, renal diseases, hematological disease, cancer, or other severe primary diseases 4. Pregnant or lactating women 5. Known allergy to ingredients or allergic constitution 6. Mental or legal disability 7. History of antibiotics administration in recent 1 month 8. Drug abuse or others

Design outcomes

Primary

Measure	Time frame
Severity of fatigue symptoms measured using Chalder fatigue questionnaire at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint)	—

Secondary

Measure	Time frame
1. Impact of fatigue on physical function measured using SF-36 physical function at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 2. Quality of life measured using Euroqol Questionnaire at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 3. Severity of TCM spleen deficiency pattern measured using spleen deficiency scale at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 4. Overall health measured using clinical global impression scale at baseline, 2 months (treatment endpoint) and 3 months (follow-up endpoint)	—

Measure

Time frame

1. Impact of fatigue on physical function measured using SF-36 physical function at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 2. Quality of life measured using Euroqol Questionnaire at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 3. Severity of TCM spleen deficiency pattern measured using spleen deficiency scale at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint) 4. Overall health measured using clinical global impression scale at baseline, 2 months (treatment endpoint) and 3 months (follow-up endpoint)

—

Countries

China

Contacts

Public ContactWenjun Zhou

wjzhou678@163.com+86 (0)212164385700

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026