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Tongluo Kaibi Tablets in Fibromyalgia Syndrome
NCT07708948Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2024
- Primary completion
- Oct 2025
- Countries
- 1
- Sponsor
- Guang'anmen Hospital
- Drugs
- tongluo kaibi
- Conditions
- fibromyalgia syndrome (FMS)
01
Overview
Phase 4, randomised, double-blind trial of tongluo kaibi in fibromyalgia syndrome (FMS) (2 arms), sponsored by Guang'anmen Hospital. Primary endpoint: Visual Analogue Scale for Pain at 8 weeks. Started Jan 2024; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tongluo Kaibi Tablet group
Tongluo Kaibi Tablets 0.9 g QD + pregabalin matching placebo (titrated up to BID after 1 week if tolerated) for 8 weeks.
Pregabalin Capsule Group
Pregabalin capsules 150 mg QD (titrated up to BID after 1 week if tolerated) + Tongluo Kaibi Tablet matching placebo 0.9 g QD for 8 weeks.
03
Who it enrols
Adults aged 18-75 with fibromyalgia syndrome (2016 ACR criteria) and Pain VAS >= 4, excluding those with severe cardiovascular, cerebrovascular, psychiatric diseases, diabetes, malignancies, or significant liver/renal impairment.
04
Endpoints
Primary
Visual Analogue Scale for Pain
Secondary
Revised Fibromyalgia Impact Questionnaire
Multidimensional Fatigue Inventory-20
Pittsburgh Sleep Quality Index
Beck II Depression Inventory
Revised Widespread Pain Index
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