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

Fibromyalgia Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05933486
• Other study ID #: 2022013P7A02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Quan Jiang
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quan Jiang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual Analogue Score	8 weeks
Secondary	MFI-20	Multidimensional Fatigue Inventory	8 weeks
Secondary	BDI	Beck Depression Inventory	8 weeks
Secondary	PSQI	Pittsburgh Sleep Quality Index	8 weeks
Secondary	WPI	Widespread Pain Index	8 weeks