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

NCT05933486 | Unknown Phase 4

• 1 other identifier: 2022013P7A02
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia Syndrome

Keywords

Tongluo-Kaibi Tablet; Traditional Chinese Medicine; Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual Analogue Score

  8 weeks

Secondary Outcomes (4)

• MFI-20

  8 weeks

• BDI

  8 weeks

• PSQI

  8 weeks

• WPI

  8 weeks

Study Arms (2)

Tongluo-Kaibi tablet plus placebo of pregabalin

EXPERIMENTAL

Drug: Tongluo-Kaibi tablet plus placebo of pregabalin

placebo of Tongluo-Kaibi tablet plus pregabalin

ACTIVE COMPARATOR

Drug: placebo of Tongluo-Kaibi tablet plus pregabalin

Interventions

Tongluo-Kaibi tablet plus placebo of pregabalin DRUG

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.

Tongluo-Kaibi tablet plus placebo of pregabalin

placebo of Tongluo-Kaibi tablet plus pregabalin DRUG

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.

placebo of Tongluo-Kaibi tablet plus pregabalin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quan Jiang: lead

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Quan Jiang

CONTACT

+8613901081632; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: September 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share