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

Not Applicable

• Conditions: Chronic Fatigue Syndrome

• Registration Number: ITMCTR2200005499
• Lead Sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Checklist Individual Strength;

Secondary Outcome Measures

Name	Time	Method
Post-Exertional Malaise;