Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
NCT ID: NCT05933486
Last Updated: 2023-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2023-09-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tongluo-Kaibi tablet plus placebo of pregabalin
Tongluo-Kaibi tablet plus placebo of pregabalin
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 pregabalin
placebo of Tongluo-Kaibi tablet plus pregabalin
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.
Interventions
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Tongluo-Kaibi tablet plus placebo of pregabalin
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 pregabalin
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Quan Jiang
OTHER
Responsible Party
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Quan Jiang
chief physician
Central Contacts
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Other Identifiers
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2022013P7A02
Identifier Type: -
Identifier Source: org_study_id
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