Back to resultsEfficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia Syndrome
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tongluo-Kaibi tablet plus placebo of pregabalin
placebo of Tongluo-Kaibi tablet plus pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tongluo-Kaibi tablet plus placebo of pregabalin
placebo of Tongluo-Kaibi tablet plus pregabalin
Arm Description
Outcomes
Primary Outcome Measures
VAS
Visual Analogue Score
Secondary Outcome Measures
MFI-20
Multidimensional Fatigue Inventory
BDI
Beck Depression Inventory
PSQI
Pittsburgh Sleep Quality Index
WPI
Widespread Pain Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05933486
Brief Title
Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
Official Title
A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Quan Jiang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tongluo-Kaibi tablet plus placebo of pregabalin
Arm Type
Experimental
Arm Title
placebo of Tongluo-Kaibi tablet plus pregabalin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tongluo-Kaibi tablet plus placebo of pregabalin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo of Tongluo-Kaibi tablet plus pregabalin
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS
Description
Visual Analogue Score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
MFI-20
Description
Multidimensional Fatigue Inventory
Time Frame
8 weeks
Title
BDI
Description
Beck Depression Inventory
Time Frame
8 weeks
Title
PSQI
Description
Pittsburgh Sleep Quality Index
Time Frame
8 weeks
Title
WPI
Description
Widespread Pain Index
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Jiang
Phone
+8613901081632
Email
doctorjq@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
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