Treatment of chronic fatigue syndrome by a Chinese herbal formula Sijunzi decoction
| ISRCTN | ISRCTN23930966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23930966 |
| Secondary identifying numbers | PZYH-DL-1.1 |
- Submission date
- 23/05/2019
- Registration date
- 28/05/2019
- Last edited
- 22/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 August 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
Contact information
Scientific
725 South Wanping Road
Xuhui District
Shanghai
200032
China
| Phone | +86 (0)2164385700 |
|---|---|
| yajlzs123@163.com |
Public
725 South Wanping Road
Xuhui District
Shanghai
200032
China
| Phone | +86 (0)212164385700 |
|---|---|
| wjzhou678@163.com |
Study information
| Study design | Multi-centre double-blinded randomized placebo-controlled parallel clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Sijunzi decoction for chronic fatigue syndrome with spleen deficiency pattern: a randomized controlled trial |
| 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(s) | 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 |
| 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 |
| 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 study start date | 24/01/2019 |
| Overall study end date | 11/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 212 |
| Total final enrolment | 127 |
| 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 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 | 30/11/2020 |
Locations
Countries of recruitment
- China
Study participating centres
Xuhui District
Shanghai
200032
China
Hongkou District
Shanghai
200437
China
Xuhui District
Shanghai
200233
China
Changning District
Shanghai
200051
China
Jiangyin
214400
China
Sponsor information
Hospital/treatment centre
725 South Wanping Road
Xuhui District
Shanghai
200032
China
| Phone | +86 (0)2164385700-1318 |
|---|---|
| lhtcmirb@sina.cn | |
"ROR" |
https://ror.org/016yezh07 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Shanghai Municipal Public Health Bureau
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2019 | 09/12/2019 | Yes | No |
| Results article | 13/04/2024 | 22/04/2024 | Yes | No |
Editorial Notes
22/04/2024: Publication reference added.
16/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2021 to 11/08/2021.
2. The intention to publish date was changed from 31/12/2021 to 31/12/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
18/05/2021: The intention to publish date was changed from 31/07/2021 to 31/12/2021.
07/10/2020: The following additional changes have been made:
1. The recruitment end date has been changed from 30/09/2020 to 30/11/2020.
2. The overall trial end date has been changed from 30/04/2021 to 31/05/2021.
3. The intention to publish date has been changed from 31/05/2021 to 31/07/2021.
16/06/2020: The following changes were made to the trial record:
1. Trial participating centres were added
2. Recruitment resumed from 22/06/2020.
03/04/2020: Due to current public health guidance, recruitment for this study has been paused. The following additional changes have been made:
1. The recruitment end date has been changed from 31/03/2020 to 30/09/2020.
2. The overall trial end date has been changed from 31/01/2021 to 30/04/2021.
3. The intention to publish date has been changed from 31/01/2021 to 31/05/2021.
09/12/2019: The recruitment end date was changed from 30/11/2019 to 31/03/2020.
09/12/2019: Publication reference added.
24/05/2019: Trial's existence confirmed by ethics committee.
