- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05933486
Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
June 28, 2023 updated by: Quan Jiang
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Quan Jiang
- Phone Number: +8613901081632
- Email: doctorjq@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: 8 weeks
|
Visual Analogue Score
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MFI-20
Time Frame: 8 weeks
|
Multidimensional Fatigue Inventory
|
8 weeks
|
BDI
Time Frame: 8 weeks
|
Beck Depression Inventory
|
8 weeks
|
PSQI
Time Frame: 8 weeks
|
Pittsburgh Sleep Quality Index
|
8 weeks
|
WPI
Time Frame: 8 weeks
|
Widespread Pain Index
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Syndrome
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 2022013P7A02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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