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Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05933486
Recruitment Status : Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description
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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.

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. VAS [ Time Frame: 8 weeks ]
    Visual Analogue Score


Secondary Outcome Measures :
  1. MFI-20 [ Time Frame: 8 weeks ]
    Multidimensional Fatigue Inventory

  2. BDI [ Time Frame: 8 weeks ]
    Beck Depression Inventory

  3. PSQI [ Time Frame: 8 weeks ]
    Pittsburgh Sleep Quality Index

  4. WPI [ Time Frame: 8 weeks ]
    Widespread Pain Index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Quan Jiang +8613901081632 doctorjq@126.com

Sponsors and Collaborators
Quan Jiang
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Tongluo-Kaibi Tablet
Traditional Chinese Medicine
Fibromyalgia Syndrome
Additional relevant MeSH terms:
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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