Condition category
Nervous System Diseases
Date applied
23/05/2019
Date assigned
28/05/2019
Last edited
28/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Chronic fatigue syndrome (CFS), also known as idiopathic chronic fatigue (ICF), is characterized by chronic disabling fatigue in the absence of an alternative diagnosis. Recent studies reported that the prevalence in UK and US fluctuates from 0.2% to 2.6%. Although not life-threatening, CFS severely impacts quality of life. Currently, there is no drug treatment approved for CFS. Therefore, complementary and alternative medicine has been considered for clinicians and patients, among which Chinese Herbal Medicine (CHM) is one of the main therapies. In Traditional Chinese Medicine (TCM), spleen deficiency is most related to lack of energy, and Sijunzi Decoction is the fundamental prescription for spleen deficiency pattern. The aim of this study is to evaluate the efficacy and safety of Sijunzi Decoction for the treatment of CFS.

Who can participate?
CFS patients aged 18-80 who meet the diagnostic criteria developed by American CDC

What does the study involve?
Participants are randomly allocated to either the Sijunzi group or the placebo group, receiving either Sijunzi Decoction or placebo (dummy treatment) twice a day for two consecutive months. The severity of fatigue symptoms is measured using a questionnaire at the start of the study, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint). Blood and fecal samples are also collected at the start and the end of treatment to further explore the potential mechanism.

What are the possible benefits and risks of participating?
The potential benefit is that CFS patients with spleen deficiency pattern may have improved symptoms and quality of life from Sijunzi Decoction treatment. Sijunzi Decoction has been widely used in China from ancient times. No obvious side effects were documented. Considering that Ginseng Radix et Rhizoma (renshen) is a principal ingredient, possible side effects may include high blood pressure, insomnia and hyperactivity.

Where is the study run from?
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (China)

When is the study starting and how long is it expected to run for?
January 2019 to January 2021

Who is funding the study?
Shanghai Three-year Action Plan for Accelerating the Development of Traditional Chinese Medicine

Who is the main contact?
1. Mr Liang Dai
yajlzs123@163.com
2. Ms Wenjun Zhou
wjzhou678@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Liang Dai

ORCID ID

Contact details

725 South Wanping Road
Xuhui District
Shanghai
200032
China
+86 (0)2164385700
yajlzs123@163.com

Type

Public

Additional contact

Ms Wenjun Zhou

ORCID ID

Contact details

725 South Wanping Road
Xuhui District
Shanghai
200032
China
+86 (0)212164385700
wjzhou678@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PZYH-DL-1.1

Study information

Scientific title

Sijunzi decoction for chronic fatigue syndrome with spleen deficiency pattern: a randomized controlled trial

Acronym

Study hypothesis

To evaluate the efficacy and safety of Sijunzi decoction for chronic fatigue syndrome with spleen deficiency pattern by comparing with placebo.

Ethics approval

Approved 25/04/2019, Ethics Committee of Longhua Hospital Affiliated Shanghai University of Traditional Chinese Medicine (3rd Floor, Building 2, 725 South Wanping Road, Xuhui District, Shanghai 200032, China; Tel: +86 (0)21 64385700 1318; Email: lhtcmirb@sina.cn), approval No. 2019LCSY020

Study design

Single-centre double-blinded randomized placebo-controlled parallel clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Chronic fatigue syndrome with spleen deficiency pattern

Intervention

Participants will be allocated to experimental or placebo arm based on the random number generated by SPSS 22.0 for Windows. Participants will be required to take the medicine twice daily for two consecutive months.

The experimental intervention is Sijunzi Decoction granules composed of four TCM herbs. One daily dosage contains 9 g Ginseng Radix et Rhizoma (Renshen), 9 g Atractylodis Macrocephalae Rhizoma (Baizhu), 9 g Poria (Fulin) and 6 g Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle. The control intervention is placebo, which is comparable with Sijunzi Decoction granules in color, smell and taste.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Severity of fatigue symptoms measured using Chalder fatigue questionnaire at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint)

Secondary outcome measures

1. Impact of fatigue on physical function measured using SF-36 physical function at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint)
2. Quality of life measured using Euroqol Questionnaire at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint)
3. Severity of TCM spleen deficiency pattern measured using spleen deficiency scale at baseline, 1 month, 2 months (treatment endpoint) and 3 months (follow-up endpoint)
4. Overall health measured using clinical global impression scale at baseline, 2 months (treatment endpoint) and 3 months (follow-up endpoint)

Overall trial start date

24/01/2019

Overall trial end date

31/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18-80 years old, both genders
2. Meet the American CDC diagnostic criteria of chronic fatigue syndrome
3. Meet the TCM criteria of spleen deficiency pattern
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

212

Participant exclusion criteria

1. Combine with mental disorders
2. Secondary fatigue due to medications or other diseases
3. Combine with severe cardiovascular diseases, cerebrovascular diseases, hepatic diseases, renal diseases, hematological disease, cancer, or other severe primary diseases
4. Pregnant or lactating women
5. Known allergy to ingredients or allergic constitution
6. Mental or legal disability
7. History of antibiotics administration in recent 1 month
8. Drug abuse or others

Recruitment start date

31/07/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

China

Trial participating centre

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
725 South Wanping Road Xuhui District
Shanghai
200032
China

Sponsor information

Organisation

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Sponsor details

725 South Wanping Road
Xuhui District
Shanghai
200032
China
+86 (0)2164385700-1318
lhtcmirb@sina.cn

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Shanghai Municipal Health Bureau

Alternative name(s)

Shanghai Municipal Public Health Bureau

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

China

Results and Publications

Publication and dissemination plan

The progress of the trial will be updated in the registry website in time. The final results are planned to be published in international academic journal after completing the trial.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from principal investigator Prof. Guang Ji. Individual participant data that underlie the results reported in the final report will become available for sharing after deidentification. Data will be available beginning 6 months and ending 36 months following the final report publication. Researchers should provide a methodologically sound proposal to get data access. And researchers will only be allowed to use the data for the prescribed aims documented in the proposal. Proposals should be directed to Liang Dai (yajlzs123@163.com). To gain access, data requestors will need to sign a data access agreement. Further informed consent may be considered according to the study aims. The shared data will only be allowed to be used by the applicant for scientific studies. No commercial activities are allowed.

Intention to publish date

31/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/05/2019: Trial's existence confirmed by ethics committee.