Fibromyalgia SyndromeNCT07555691
Yishen Shujin Decoction for Fibromyalgia Syndrome
A study testing YishenShujin Decoction in people with Fibromyalgia Syndrome, run by Juan Jiao at 1 site in China.
Trial summary
This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- YishenShujin Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in 2016.
- TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency.
- aged 18 years old and above, 75 years old and below.
- pain VAS score ≥ 4.
- not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month.
- Sign the informed consent.
Who cannot join
- Patients with severe depression or anxiety ;
- patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ;
- Lactating or pregnant women ;
- patients with allergy to therapeutic ingredients ;
- patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ;
- patients who have recently participated in clinical trials of the same indications ；
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- Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning.
- Contraindications include:
- History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc.
- Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc.
- Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc.
- Claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Juan Jiao, 8618611511082, jiao.juan@hotmail.com
About this study
Official title: A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome
This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- YishenShujin Decoction, placebo
- Keywords
- MRI, RCT, Chinese medicine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YishenShujin DecoctionDrug
Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
placeboDrug
The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| the placebo group | Placebo comparator | The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks. Receives: Drug: placebo |
| the YishenShujin Decoction group | Experimental | Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks. Receives: Drug: YishenShujin Decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the Brief Pain Inventory (BPI) from baseline.
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
Secondary outcomes (11)
The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.
This scale consists of two subdomains to evaluate the overall severity of fibromyalgia according to the ACR fibromyalgia diagnostic criteria.
The Widespread Pain Index (WPI) assesses the extent and diffuseness of body pain, with scores ranging from 0 to 19. Higher scores indicate more widespread, diffuse pain distribution across the body.
The Symptom Severity Score (SSS) evaluates the severity of core accompanying fibromyalgia symptoms, with total scores ranging from 0 to 12. Higher scores represent greater severity of general somatic and associated symptomatic burden.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Beck II Depression Inventory（BDI） from baseline.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Measured: Baseline, week 2, week 4, week 8, week 12 and week 24
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Measured: Week 12.
Brain morphology measured by structural MRI
To compare the changes in brain structure and morphology in patients with fibromyalgia before and after treatment by structural MRI. The images were acquired by a Siemens 3.0T Skyra scanner (Siemens; Munich, Germany) using fast spoiled gradient-echo sequence. Images contain whole brain, grey matter, white matter, atlas-based regions of interest for the patient group and healthy controls. The structural MRI images were processed with CAT 12 software (Version12.7, r1700). In detail, the voxel-based morphometry pipeline includes initial and refined voxel-based processing.
Measured: Before and at the end of the study ( 0, 12 weeks ).
Brain functional connectivity measured by function MRI
To compare the changes in connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by function MRI. The scanning sequence is set up under the guidance of an imaging professional, while ensuring that the participants undergo the MRI scans with their eyes closed but awake; head movements do not exceed 1.5 mm in translation in any direction and 1.5° in rotation in any direction.
Measured: Before and at the end of the study ( 0, 12 weeks ).
Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids
Serum IL-6, TNF-α, HMGB1 were tested by ELISA; serum MDA, GSH were detected using biochemical colorimetric method; circulating bile acid components were quantified with liquid chromatography-mass spectrometry (LC-MS). All blood samples were collected at baseline (0 week) and study endpoint (12 weeks).
Measured: Before and at the end of the study ( 0, 12 weeks ).
Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration
Intestinal flora composition was profiled by 16S rRNA high-throughput sequencing; fecal bile acids and short-chain fatty acids were both determined via LC-MS/MS technology. Fecal specimens were collected at baseline (0 week) and study endpoint (12 weeks).
Measured: Before and at the end of the study ( 0, 12 weeks ).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Mar 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Jiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555691
- Sponsor's protocol ID
- 2023-QNQS-09
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT07555691
- Acronym / sponsor ID
- 2023-QNQS-09
- Conditions
- Fibromyalgia Syndrome
- Keywords
- MRI, RCT, Chinese medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Juan JiaoUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the placebo group | Placebo comparator | Drug: placeboThe placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks. |
| the YishenShujin Decoction group | Experimental | Drug: YishenShujin DecoctionPatients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in 2016.
- TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency.
- aged 18 years old and above, 75 years old and below.
- pain VAS score ≥ 4.
- not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month.
Key exclusion criteria (12 listed)
- Patients with severe depression or anxiety ;
- patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ;
- Lactating or pregnant women ;
- patients with allergy to therapeutic ingredients ;
- patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YishenShujin DecoctionPatients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks. | Drug | the YishenShujin Decoction group |
| placeboThe placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks. | Drug | the placebo group |
Primary outcome
The change of the Brief Pain Inventory (BPI) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
11 secondary outcomes
The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Beck II Depression Inventory（BDI） from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Perceived Stress Scale (PSS) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Time frame: Week 12.
Brain morphology measured by structural MRI
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Brain functional connectivity measured by function MRI
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YishenShujin Decoction in people with Fibromyalgia Syndrome, run by Juan Jiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Jiao (010-88001132, jiao.juan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the Brief Pain Inventory (BPI) from baseline. (time frame: Baseline, week 2, week 4, week 8, week 12 and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.