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

Intervention / Treatment

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

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
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.

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

Quan Jiang

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

Keywords

Additional Relevant MeSH Terms

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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