Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial

Chronic Fatigue Syndrome Clinical Trial

Official title:

Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964533
• Other study ID #: 20161120
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2016
• Last updated: November 15, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Guangzhou University of Chinese Medicine
• Contact: Haili Luo
• Phone: 13825017002
• Email: 839601539[@]qq.com
• Is FDA regulated: No
• Health authority: China:Guangdong province bureau of traditional Chinese medicine
• Study type: Interventional

Clinical Trial Summary

Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves

Exclusion Criteria:

• 1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease

Study Design

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Other:
• thunder-fire moxibustion therapy
burn moxa stick and heat shenque acupoint
• common moxa-stick moxibustion
burn moxa stick and heat shenque acupoint

Locations

Country	Name	City	State
China	The Second Clinical Medical College of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Tian L, Wang J, Luo C, Sun R, Zhang X, Yuan B, Du XZ. [Moxibustion at Gaohuang (BL 43) for chronic fatigue syndrome: a randomized controlled trial]. Zhongguo Zhen Jiu. 2015 Nov;35(11):1127-30. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue rating scale score		5 minutes	No
Secondary	content of peripheral t-lymphocyte subsets		3 minutes	No