Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02924831
Other study ID # XTCX2016-QXZ
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received September 27, 2016
Last updated October 3, 2016
Start date November 2016
Est. completion date July 2018

Study information

Verified date July 2016
Source Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
Contact Liang feng xia, Doctor
Phone +86 18971371818
Email 315938821@qq.com
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Hubei Province
Study type Interventional

Clinical Trial Summary

1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).

2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 210
Est. completion date July 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. The patients meeting criteria of CFS;

2. Aged from 18-65;

3. With no skin lesions for the acupuncture area;

4. Sign on the Informed Consent Form;

Exclusion Criteria:

1. Patients who can't accept and are afraid of acupuncture in the acupuncture group.

2. Patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system.

3. Persons suffering from a mental disease, Alzheimer's disease or cancer.

4. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation.

5. Pregnant women and nursing mothers.

6. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function.

7. Persons with alcohol and drug abuse history.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Acupuncture
Stimulating acupoints by using stainless steel needles with manual manipulation.
moxibustion
Stimulating acupoints by using burned moxa
placebo
Stimulating acupoints by using stainless steel needles without manual manipulation.

Locations

Country Name City State
China Hubei university of TCM Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chalder's Fatigue Scale Score(CFSS) In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3. Two years No
Secondary Numeric Rating Scale(NRS) NRC is a 10cm scale to assess the fatigue degree ranging from 0 to 10, the score of 0 stands for 'no fatigue' and 10 for 'serious'. Two years No
Secondary 36-item Short-Form Health Survey (SF-36) SF-36 consists of 36 items categorized as 8 dimensions: social functioning (2 items), role limitation-emotion (3 items), mental health (5 items), physical functioning (10 items), role limitation-physical (4 items), bodily pain (2 items), vitality (4 items), general health (5 items) and 1 question of health change in recent one year. Two years No
Secondary Deficiency of Qi Scale Score (DQSS) In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'. Two years No
Secondary Total Power(TP) Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device. Two years No
Secondary Low frequency(LF) Low frequency band (ms²/Hz, %), detected by portable HRV device. Two years No
Secondary High frequency (HF) High frequency band (ms²/Hz, %), detected by portable HRV device. Two years No
Secondary LF/HF Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results. Two years No
Secondary Ultra-low frequency(ULF) Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device. Two years No
Secondary Very low frequency Very low frequency band (ms²/Hz, %),,detected by portable HRV device. Two years No
See also
  Status Clinical Trial Phase
Recruiting NCT05454683 - Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome N/A
Completed NCT01686074 - Motor Control in Chronic Fatigue Syndrome and Fibromyalgia N/A
Completed NCT02075489 - Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans N/A
Completed NCT01651754 - Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome N/A
Completed NCT00540254 - Behavioral Insomnia Therapy With Chronic Fatigue Syndrome Phase 1/Phase 2
Active, not recruiting NCT00071162 - Genetics of Fibromyalgia N/A
Withdrawn NCT04870476 - Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Recruiting NCT04542161 - Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Recruiting NCT03807973 - Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. Phase 1
Recruiting NCT05719493 - Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +) N/A
Recruiting NCT05967052 - Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation Phase 2
Terminated NCT01730495 - Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome Phase 2
Completed NCT01650636 - Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process N/A
Completed NCT01156909 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Phase 2
Completed NCT01046370 - A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia N/A
Completed NCT00100412 - Hyporeactivity and Gulf War Illness N/A
Recruiting NCT06128967 - A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial Phase 3
Completed NCT02669212 - Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health N/A
Not yet recruiting NCT06011135 - Exploring Worry in CFS/ME