Fibromyalgia SyndromePhase 4NCT05933486
Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
A Phase 4 study of Fibromyalgia Syndrome, run by Quan Jiang.
Trial summary
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets in patients with Fibromyalgia Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia Syndrome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2024
- 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
- Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in 2016.
- Pain VAS score ≥ 4 points.
- The variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks.
Who cannot join
- Severe cardiovascular and cerebrovascular diseases.
- Malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases.
- ALT and AST are more than 2 times the upper limit of normal.
- Cr is more than 1.2 times the upper limit of normal.
- Allergic constitution or allergic to experimental drugs Tongluo-Kaibi tablet, pregabalin capsules, excipients or similar ingredients.
- Pregnant, lactating or recently planned pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets in patients with Fibromyalgia Syndrome.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Tongluo-Kaibi tablet plus placebo of pregabalin, placebo of Tongluo-Kaibi tablet plus pregabalin
- Keywords
- Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome
- 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 tablet plus placebo of pregabalinDrug
Tongluo-Kaibi Tablet 0.93g qd； Placebo of pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week.
placebo of Tongluo-Kaibi tablet plus pregabalinDrug
placebo of Tongluo-Kaibi Tablet 0.93g qd； Pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week.
| Study group | Role | What they receive |
|---|---|---|
| Tongluo-Kaibi tablet plus placebo of pregabalin | Experimental | Not described Receives: Drug: Tongluo-Kaibi tablet plus placebo of pregabalin |
| placebo of Tongluo-Kaibi tablet plus pregabalin | Active comparator | Not described Receives: Drug: placebo of Tongluo-Kaibi tablet plus pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analogue Score
Measured: 8 weeks
Secondary outcomes (4)
MFI-20
Multidimensional Fatigue Inventory
Measured: 8 weeks
BDI
Beck Depression Inventory
Measured: 8 weeks
PSQI
Pittsburgh Sleep Quality Index
Measured: 8 weeks
WPI
Widespread Pain Index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionSep 2024 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933486
- Sponsor's protocol ID
- 2022013P7A02
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. 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 Tablet in the Treatment of Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05933486
- Acronym / sponsor ID
- 2022013P7A02
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Quan JiangUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 6 Jul 2023 (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 study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets in patients with Fibromyalgia Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongluo-Kaibi tablet plus placebo of pregabalin | Experimental | Drug: Tongluo-Kaibi tablet plus placebo of pregabalin |
| placebo of Tongluo-Kaibi tablet plus pregabalin | Active comparator | Drug: placebo of Tongluo-Kaibi tablet plus pregabalin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in 2016.
- Pain VAS score ≥ 4 points.
- The variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks.
Key exclusion criteria (6 listed)
- Severe cardiovascular and cerebrovascular diseases.
- Malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases.
- ALT and AST are more than 2 times the upper limit of normal.
- Cr is more than 1.2 times the upper limit of normal.
- Allergic constitution or allergic to experimental drugs Tongluo-Kaibi tablet, pregabalin capsules, excipients or similar ingredients.
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 tablet plus placebo of pregabalinTongluo-Kaibi Tablet 0.93g qd； Placebo of pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week. | Drug | Tongluo-Kaibi tablet plus placebo of pregabalin |
| placebo of Tongluo-Kaibi tablet plus pregabalinplacebo of Tongluo-Kaibi Tablet 0.93g qd； Pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week. | Drug | placebo of Tongluo-Kaibi tablet plus pregabalin |
Primary outcome
VAS
Time frame: 8 weeks
Visual Analogue Score
4 secondary outcomes
MFI-20
Time frame: 8 weeks
BDI
Time frame: 8 weeks
PSQI
Time frame: 8 weeks
WPI
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Fibromyalgia Syndrome, run by Quan Jiang.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan Jiang (+8613901081632, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 8 weeks). 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 6 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.