Fibromyalgia SyndromeNCT07736144
Mechanism Study of Yangyin Roujin Formula in the Treatment of Fibromyalgia Syndrome
A study testing Yangyin Roujin Decoction in people with Fibromyalgia Syndrome, run by Juan Jiao at 1 site in China.
Trial summary
This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Yangyin Roujin Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 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
- Healthy volunteers accepted
- 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 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 ； Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning.
- Patients who received antibiotics, probiotics, prebiotics, synbiotics, laxatives, or glucocorticoids within 3 months prior to enrollment; Patients with a history of severe gastrointestinal organic diseases, including inflammatory bowel disease, gastric ulcer, duodenal ulcer, intestinal polyposis, intestinal resection, chronic diarrhea or chronic constipation;
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: Efficacy and Mechanism of Yangyin Roujin Formula in Fibromyalgia Syndrome: A Randomized Controlled Trial
This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Yangyin Roujin Decoction, placebo
- Keywords
- Fibromyalgia Syndrome, Yangyin Roujin Formula, Randomized Controlled Trial, Herbal Medicine, Pain, Gut Microbiota, Magnetic Resonance Imaging
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangyin Roujin DecoctionDrug
YangyinRoujin Formula, a Chinese herbal compound formula.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 YangyinRoujin 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 YangyinRoujin Decoction group | Experimental | Patients in the group received YangyinRoujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks. Receives: Drug: Yangyin Roujin Decoction |
| 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 YangyinRoujin 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the Pain VAS score from baseline.
The 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, and week 12.
Secondary outcomes (10)
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, and week 12.
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, and week 12.
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, and week 12.
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, and week 12.
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, and week 12.
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, and week 12.
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
Analysis of serological indicators
A total of 10 mL fasting peripheral venous blood will be collected from subjects before and after treatment. After standing for serum separation, serum samples will be aliquoted and stored in a -80°C ultra-low temperature freezer for unified laboratory testing of serological indicators.
Measured: 0, 12 weeks
Gut microbiota analysis
Approximately 50 mL fresh fecal samples will be collected before and after treatment, transferred into sterile enzyme-free sampling tubes, snap-frozen in liquid nitrogen, and preserved at -80°C. Subsequent 16S rRNA sequencing analysis of gut microbiota will be performed uniformly.
Measured: 0, 12 weeks
Brain imaging analysis
Standardized brain magnetic resonance imaging (MRI) scans will be performed on all subjects before and after treatment with consistent scanner models and scanning parameters. Raw DICOM imaging data will be archived for subsequent structural and functional brain analysis.
Measured: 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 posted30 Jul 2026
- Study start1 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 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
- 60 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
- NCT07736144
- Sponsor's protocol ID
- 20260708
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2026
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Yangyin Roujin Formula in Fibromyalgia Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07736144
- Acronym / sponsor ID
- 20260708
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome, Yangyin Roujin Formula, Randomized Controlled Trial, Herbal Medicine, Pain, Gut Microbiota, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Juan JiaoUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Jul 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 prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.
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 YangyinRoujin Decoction group | Experimental | Drug: Yangyin Roujin DecoctionPatients in the group received YangyinRoujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks. |
| 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 YangyinRoujin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- 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 (2 listed)
- 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 ； Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning.
- Patients who received antibiotics, probiotics, prebiotics, synbiotics, laxatives, or glucocorticoids within 3 months prior to enrollment; Patients with a history of severe gastrointestinal organic diseases, including inflammatory bowel disease, gastric ulcer, duodenal ulcer, intestinal polyposis, intestinal resection, chronic diarrhea or chronic constipation;
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 |
|---|---|---|
| Yangyin Roujin DecoctionYangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks. | Drug | the YangyinRoujin 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 YangyinRoujin 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 Pain VAS score from baseline.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
10 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, and week 12.
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Beck II Depression Inventory（BDI） from baseline.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Perceived Stress Scale (PSS) from baseline.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Time frame: Week 12
Analysis of serological indicators
Time frame: 0, 12 weeks
Gut microbiota analysis
Time frame: 0, 12 weeks
Brain imaging analysis
Time frame: 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 14 Sep 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 Yangyin Roujin 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 2 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 14 Sep 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 Pain VAS score from baseline. (time frame: Baseline, week 2, week 4, week 8, and week 12.). 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 14 Sep 2026.