FibromyalgiaEarly Phase 1NCT05508516
Shugan Dingtong Decoction in the Treatment of Fibromyalgia
A Early Phase 1 study testing Shugan Dingtong decoction and Duloxetine Hydrochloride in people with Fibromyalgia, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Shugan Dingtong decoction and Duloxetine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 18 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-70 years old.
- patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
- patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
- pain scores between3 and 7 on visual analogue scale.
- patients sign the informed consent forms.
Who cannot join
- pregnant and lactating women.
- patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
- patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
- patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
- patients with severe pain resulted from diabetic and postherpetic neuralgia.
- patients who are allergic to the drugs used in this study.
- patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.
- Conditions
- Fibromyalgia
- Being tested
- Shugan Dingtong decoction, Duloxetine Hydrochloride
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shugan Dingtong decoctionDrug
Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
Duloxetine HydrochlorideDrug
Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Shugan Dingtong decoction | Experimental | Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. Receives: Drug: Shugan Dingtong decoction |
| duloxetine hydrochloride | Active comparator | Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. Receives: Drug: Duloxetine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale pain scores
The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain.
Measured: 12 Weeks
Secondary outcomes (4)
Fibromyalgia impact questionnaire
The fibromyalgia impact questionnaire will be used to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. This score ranges from 0 to 100 and high scores are related to greater impact on life quality.
Measured: 12 Weeks
Fatigue scale-14
The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue.
Measured: 12 Weeks
Pittsburgh sleep quality index
Pittsburgh sleep quality index will be used to assess the sleep quality within the past month. The higher the score, the worse sleep quality. A total of PSQI score greater than five yielded a diagnostic sensitivity of 89.6% and specificity of 86.5%
Measured: 12 Weeks
Traditional Chinses medicine symptom score
Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Sep 2022
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Xu, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508516
- Sponsor's protocol ID
- LZhang
- Status last verified
- Nov 2024
- First submitted
- 18 Aug 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Z, Lan T, Zhang Y, Guo Z, Yu H, Sun G, Wang Z, Yan Z, Tao Q, Xu Y. Osteoarthritis and Degree of Fatigue are Associated with Pain Levels in Patients with Fibromyalgia Syndrome: A Cross-Sectional Study of 394 Patients. Int J Gen Med. 2025 Jan 31;18:497-507. doi: 10.2147/IJGM.S503902. eCollection 2025.
PubMed 39906173
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT05508516
- Acronym / sponsor ID
- LZhang
- Conditions
- Fibromyalgia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 19 Aug 2022 (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.
Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shugan Dingtong decoction | Experimental | Drug: Shugan Dingtong decoctionPatients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. |
| duloxetine hydrochloride | Active comparator | Drug: Duloxetine HydrochloridePatients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients aged 18-70 years old.
- patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
- patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
- pain scores between3 and 7 on visual analogue scale.
- patients sign the informed consent forms.
Key exclusion criteria (7 listed)
- pregnant and lactating women.
- patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
- patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
- patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
- patients with severe pain resulted from diabetic and 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 |
|---|---|---|
| Shugan Dingtong decoctionPatients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. | Drug | Shugan Dingtong decoction |
| Duloxetine HydrochloridePatients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. | Drug | duloxetine hydrochloride |
Primary outcome
Visual analogue scale pain scores
Time frame: 12 Weeks
The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain.
4 secondary outcomes
Fibromyalgia impact questionnaire
Time frame: 12 Weeks
Fatigue scale-14
Time frame: 12 Weeks
Pittsburgh sleep quality index
Time frame: 12 Weeks
Traditional Chinses medicine symptom score
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 39906173Wang Z, Lan T, Zhang Y, Guo Z, Yu H, Sun G, Wang Z, Yan Z, Tao Q, Xu Y. Osteoarthritis and Degree of Fatigue are Associated with Pain Levels in Patients with Fibromyalgia Syndrome: A Cross-Sectional Study of 394 Patients. Int J Gen Med. 2025 Jan 31;18:497-507. doi: 10.2147/IJGM.S503902. eCollection 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Shugan Dingtong decoction and Duloxetine Hydrochloride in people with Fibromyalgia, run by China-Japan Friendship Hospital 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 19 Nov 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale pain scores (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508516, which also lists 1 linked publication.
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 19 Nov 2024.