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Yi'anning pill is a randomized, double-blind, positive drug parallel control and multi-center clinical trial for the protection of traditional Chinese medicine varieties for the efficacy and safety of the treatment of chronic fatigue syndrome (qi and blood deficiency and liver and kidney deficiency)

Yi'anning pill is a randomized, double-blind, positive drug parallel control and multi-center clinical trial for the protection of traditional Chinese medicine varieties for the efficacy and safety of the treatment of chronic fatigue syndrome (qi and blood deficiency and liver and kidney deficiency)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061653
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-16
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Chronic fatigue syndrome

Interventions

Experimental group:Yi'anning pills, specifications: 3.1g/18 pills, oral, 18 pills each time, 2 times a day, fatigue granule simulater, specifications 6g/bag, boiled water, 2 bags each time, 2 times a
The control group:Yi'anning pill simulating agent, specifications: 3.1g/18 pills, oral, 18 pills each time, 2 times a day, fatigue granules, specifications 6g/bag, boiled water, 2 bags each time, 2 ti

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for chronic fatigue syndrome in Western medicine; 2. Meet the dialectical criteria for the evidence of qi and blood deficiency and liver and kidney deficiency in traditional Chinese medicine; 3. Aged 18 - 65 years; 4. The subject's informed consent, voluntary subjecting and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have the primary disease that causes chronic fatigue, internal medicine diseases such as myocardial infarction, heart failure, emphysema, cirrhosis, chronic renal failure, etc.; rheumatic immune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.; infectious diseases such as AIDS, viral hepatitis B, syphilis, etc.; neurological diseases such as multiple sclerosis, epilepsy, stroke, nerve function damage caused by drug side effects, etc.; endocrine diseases such as adrenal insufficiency, pituitary dysfunction, hypothyroidism, hypothyroidism, untreated or unstable diabetes mellitus; severe cerebral organic disease; severe mental illness or affective disorder; severe primary heart, liver, lung, kidney, blood, or serious disease affecting their survival, such as tumors or AIDS; abnormal liver and kidney function ALT, AST >= upper limit of 1.5 times the normal value, Cr > upper limit of normal value; 2. BMI >= 35 kg/m2; 3. Use Chinese medicines and proprietary Chinese medicines or health care products with the effect of tonifying qi and invigorating blood, benefiting liver and kidneys, nourishing the heart and calming the mind within one week; 4. Pregnant, lactating women or those who are unwilling to take contraception during the trial period and within 1 month after the end of the trial; 5. Suspected or indeed have a history of alcohol or drug abuse; 6. Poor compliance cannot cooperate to complete the test; 7. Allergic constitution, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the drugs used in this test; 8. Those who have participated in clinical trials of other drugs in the past 1 month; 9. Other factors that the investigator or assistant investigator determines are not appropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Fatigue Scale -14 score;

Secondary

MeasureTime frame
Physical and mental health reports;Depression self-assessment scale;Anxiety self-assessment scale;TCM Symptom Score;

Countries

China

Contacts

Public ContactLi Bin

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

ybkj345@126.com+86 18910781852

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026