Fibromyalgia SyndromePhase 4NCT07708948
Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome
A Phase 4 study testing Tongluo Kaibi Tablet and Pregabalin capsule in people with Fibromyalgia Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential… 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?
- Tongluo Kaibi Tablet and Pregabalin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Mar 2026
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years at the time of informed consent acquisition, regardless of gender;
- Meet the 2016 fibromyalgia classification criteria established by the American College of Rheumatology;
- Score ≥4 on the Visual Analogue Scale for Pain (Pain VAS) at screening;
- Agree to receive 8 weeks of treatment and related examinations, and sign the informed consent form;
- No medication for fibromyalgia, or the types and dosages of medications for fibromyalgia have remained stable for at least 2 weeks.
Who cannot join
- Have a medical history or confirmed diagnosis of any of the following conditions during screening: severe cardiovascular and cerebrovascular diseases; combined diabetes, malignant tumors, hematological diseases, inflammatory arthritis or other severe progressive systemic diseases; other psychiatric disorders leading to inability or unwillingness to cooperate with the trial;
- Any laboratory test result before screening meets the following criteria: liver and renal function tests show ALT or AST > 2 times the upper limit of normal (ULN), or creatinine (Cr) > 1.2 times ULN (refer to the normal reference range of the laboratory at each study center); other clinically significant abnormal laboratory parameters judged by investigators to disqualify subjects from enrollment;
- Allergic constitution, or hypersensitivity to the investigational product Tongluo Kaibi Tablets, pregabalin capsules, excipients or similar ingredients; Suspected or confirmed history of alcohol or substance abuse;
- Pregnant or lactating women, women planning pregnancy in the near future, or those unwilling to adopt contraceptive measures;
- Receiving Tongluo Kaibi Tablets at enrollment;
- Participation in any other clinical trial within 3 months prior to enrollment;
- Any other conditions judged by investigators to render the subject unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: A Multicenter, Randomized, Double-Blind Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome
Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Tongluo Kaibi Tablet, Pregabalin capsule
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongluo Kaibi TabletDrug
Tongluo Kaibi Tablet is composed of eight Chinese herbal medicines: Nux Vomica Powder, Radix Cyathulae, Radix Angelicae Sinensis, Flos Carthami, Fructus Chaenomelis, Herba Schizonepetae, Radix Saposhnikoviae and Scorpio. It dispels wind and unblocks collaterals, activates blood circulation and dissipates stagnation. It is indicated for joint pain and swelling caused by intermingled cold-heat complicated with blood stasis obstructing collaterals. Since its launch, it has been widely used in the treatment of rheumatic diseases.
Pregabalin capsuleDrug
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
| Study group | Role | What they receive |
|---|---|---|
| Tongluo Kaibi Tablet group | Experimental | Tongluo Kaibi Tablets, 0.9 g per dose, once daily; pregabalin matching placebo, 150 mg per dose, once daily. After one week, the dose of pregabalin matching placebo will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks. Receives: Drug: Tongluo Kaibi Tablet |
| Pregabalin Capsule Group | Active comparator | Tongluo Kaibi Tablet matching placebo, 0.9 g per dose, once daily; pregabalin capsules, 150 mg per dose, once daily. After one week, the dose of pregabalin capsules will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks. Receives: Drug: Pregabalin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
Measured: Baseline, week 4, and week 8
Secondary outcomes (5)
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 4, and week 8.
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 4, and week 8.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, week 4, and week 8.
The Beck II Depression Inventory (BDI)
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 4, and week 8.
The change of the revised Widespread Pain Index(WPI)from baseline.
The total score of the Widespread Pain Index (WPI) ranges from 0 to 19, corresponding to 19 standard pain sites all over the body. One point is assigned if pain is present at a site within the past week, and zero point if no pain occurs. A higher total score indicates a wider distribution of pain across the body.
Measured: Baseline, week 4, and week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jan 2024
- Primary completion31 Oct 2025
- Study completion1 Mar 2026
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708948
- Sponsor's protocol ID
- 2022013P7A03
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT07708948
- Acronym / sponsor ID
- 2022013P7A03
- Conditions
- Fibromyalgia Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 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.
Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongluo Kaibi Tablet group | Experimental | Drug: Tongluo Kaibi TabletTongluo Kaibi Tablets, 0.9 g per dose, once daily; pregabalin matching placebo, 150 mg per dose, once daily. After one week, the dose of pregabalin matching placebo will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks. |
| Pregabalin Capsule Group | Active comparator | Drug: Pregabalin capsuleTongluo Kaibi Tablet matching placebo, 0.9 g per dose, once daily; pregabalin capsules, 150 mg per dose, once daily. After one week, the dose of pregabalin capsules will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 75 years at the time of informed consent acquisition, regardless of gender;
- Meet the 2016 fibromyalgia classification criteria established by the American College of Rheumatology;
- Score ≥4 on the Visual Analogue Scale for Pain (Pain VAS) at screening;
- Agree to receive 8 weeks of treatment and related examinations, and sign the informed consent form;
- No medication for fibromyalgia, or the types and dosages of medications for fibromyalgia have remained stable for at least 2 weeks.
Key exclusion criteria (7 listed)
- Have a medical history or confirmed diagnosis of any of the following conditions during screening: severe cardiovascular and cerebrovascular diseases; combined diabetes, malignant tumors, hematological diseases, inflammatory arthritis or other severe progressive systemic diseases; other psychiatric disorders leading to inability or unwillingness to cooperate with the trial;
- Any laboratory test result before screening meets the following criteria: liver and renal function tests show ALT or AST > 2 times the upper limit of normal (ULN), or creatinine (Cr) > 1.2 times ULN (refer to the normal reference range of the laboratory at each study center); other clinically significant abnormal laboratory parameters judged by investigators to disqualify subjects from enrollment;
- Allergic constitution, or hypersensitivity to the investigational product Tongluo Kaibi Tablets, pregabalin capsules, excipients or similar ingredients; Suspected or confirmed history of alcohol or substance abuse;
- Pregnant or lactating women, women planning pregnancy in the near future, or those unwilling to adopt contraceptive measures;
- Receiving Tongluo Kaibi Tablets at enrollment;
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 |
|---|---|---|
| Tongluo Kaibi TabletTongluo Kaibi Tablet is composed of eight Chinese herbal medicines: Nux Vomica Powder, Radix Cyathulae, Radix Angelicae Sinensis, Flos Carthami, Fructus Chaenomelis, Herba Schizonepetae, Radix Saposhnikoviae and Scorpio. It dispels wind and unblocks collaterals, activates blood circulation and dissipates stagnation. It is indicated for joint pain and swelling caused by intermingled cold-heat complicated with blood stasis obstructing collaterals. Since its launch, it has been widely used in the treatment of rheumatic diseases. | Drug | Tongluo Kaibi Tablet group |
| Pregabalin capsulePregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China. | Drug | Pregabalin Capsule Group |
Primary outcome
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Time frame: Baseline, week 4, and week 8
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
5 secondary outcomes
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Time frame: Baseline, week 4, and week 8.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time frame: Baseline, week 4, and week 8.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Time frame: Baseline, week 4, and week 8.
The Beck II Depression Inventory (BDI)
Time frame: Baseline, week 4, and week 8.
The change of the revised Widespread Pain Index(WPI)from baseline.
Time frame: Baseline, week 4, and week 8.
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 17 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. 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 Phase 4 study testing Tongluo Kaibi Tablet and Pregabalin capsule in people with Fibromyalgia Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 17 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The change of the Visual Analogue Scale (VAS) for pain from baseline. (time frame: Baseline, week 4, and week 8). 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 17 Jul 2026.