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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tongluo-Kaibi tablet plus placebo of pregabalin | Experimental |
| |
| placebo of Tongluo-Kaibi tablet plus pregabalin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongluo-Kaibi tablet plus placebo of pregabalin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Visual Analogue Score | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MFI-20 | Multidimensional Fatigue Inventory | 8 weeks |
| BDI | Beck Depression Inventory | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Jiang | Contact | +8613901081632 | doctorjq@126.com |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| placebo of Tongluo-Kaibi tablet plus pregabalin | Drug | 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. |
|
| PSQI | Pittsburgh Sleep Quality Index | 8 weeks |
| WPI | Widespread Pain Index | 8 weeks |
| D009422 |
| Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |