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Evaluation of Clinical Efficacy and Mechanism of Yanling Yishou Decoction on Intervention of Chronic Fatigue Syndrome with Deficiency of Heart and Spleen

Evaluation of Clinical Efficacy and Mechanism of Yanling Yishou Decoction on Intervention of Chronic Fatigue Syndrome with Deficiency of Heart and Spleen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005499
Enrollment
Unknown
Registered
2022-01-05
Start date
2022-01-05
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Chronic Fatigue Syndrome

Interventions

1:Yan-Ling-Yi-Shou Decoction
2:Yan-Ling-Yi-Shou Decoction+Graded Exercise Therapy

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1).Meet the CDC criteria, revised in 2003, for CFS. (2).Meet the judgment standard of TCM diagnosis of deficiency of heart and spleen syndrome (3).Age 18 to 65. (4).A score of =35 on the Checklist Individual Strength Scale. (5).Participant signed the informed consent form. (6).Participant agreed to avoid other CFS medications during the trial.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will be excluded: (1).Participant had limited physical function and cannot perform moderate exercise. (2).Participant is currently pregnant or breastfeeding (3).Participant had one of these following diseases that may cause chronic fatigue: a history of cancer, sleep apnea, narcolepsy, hepatitis B or C virus infection, anemia, tuberculosis, endocrine/metabolic diseases (diabetes, hyperthyroidism, hypothyroidism, severe obesity (body mass index (BMI) = 35), autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis). (4).Participant had one of these following psychosocial diseases that may cause chronic fatigue: severe depression, anxiety neurosis, schizophrenia, bipolar disorder, alcohol or other forms of substance abuse. (5).Participant had take one of these following drugs within the first 2 weeks: antidepressants, anxiolytics, sleeping pills or antihistamines. (6).Participant will purchase or take vitamin or mineral supplements during this study period. (7).Participant undertake too much workload (for example, undertake multiple tasks); (8).Participant had a history of surgery within six months. (9).Participant had accompanied by severe heart, kidney, lung, liver, brain diseases, or severe physical dysfunction. Clinical drug intervention are not available. (10) Participant 's vital signs are not stable; (11).Participant will have a frequent changes in the working environment or other situations that are likely to cause loss to follow-up. (12).Participant had participated in other clinical trials at present.

Design outcomes

Primary

MeasureTime frame
Checklist Individual Strength;

Secondary

MeasureTime frame
Post-Exertional Malaise;

Countries

china

Contacts

Public Contactzhou qing
13601401869@163.com13601401869

Outcome results

None listed

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