Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
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ClinicalTrials.gov Identifier: NCT05933486 |
Recruitment Status :
Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia Syndrome | Drug: Tongluo-Kaibi tablet plus placebo of pregabalin Drug: placebo of Tongluo-Kaibi tablet plus pregabalin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome |
Estimated Study Start Date : | September 2023 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Tongluo-Kaibi tablet plus placebo of pregabalin |
Drug: 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. |
Active Comparator: placebo of Tongluo-Kaibi tablet plus pregabalin |
Drug: 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. |
- VAS [ Time Frame: 8 weeks ]Visual Analogue Score
- MFI-20 [ Time Frame: 8 weeks ]Multidimensional Fatigue Inventory
- BDI [ Time Frame: 8 weeks ]Beck Depression Inventory
- PSQI [ Time Frame: 8 weeks ]Pittsburgh Sleep Quality Index
- WPI [ Time Frame: 8 weeks ]Widespread Pain Index
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933486
Contact: Quan Jiang | +8613901081632 | doctorjq@126.com |
Responsible Party: | Quan Jiang, chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
ClinicalTrials.gov Identifier: | NCT05933486 |
Other Study ID Numbers: |
2022013P7A02 |
First Posted: | July 6, 2023 Key Record Dates |
Last Update Posted: | July 6, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tongluo-Kaibi Tablet Traditional Chinese Medicine Fibromyalgia Syndrome |
Fibromyalgia Myofascial Pain Syndromes Syndrome Disease Pathologic Processes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pregabalin Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |