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

Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Drug: Pregabalin capsule; Drug: Tongluo Kaibi Tablet

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 75 years at the time of informed consent acquisition, regardless of gender;
• Meet the 2016 fibromyalgia classification criteria established by the American College of Rheumatology;
• Score ≥4 on the Visual Analogue Scale for Pain (Pain VAS) at screening;
• Agree to receive 8 weeks of treatment and related examinations, and sign the informed consent form;
• No medication for fibromyalgia, or the types and dosages of medications for fibromyalgia have remained stable for at least 2 weeks.

Exclusion Criteria:

• Have a medical history or confirmed diagnosis of any of the following conditions during screening: severe cardiovascular and cerebrovascular diseases; combined diabetes, malignant tumors, hematological diseases, inflammatory arthritis or other severe progressive systemic diseases; other psychiatric disorders leading to inability or unwillingness to cooperate with the trial;
• Any laboratory test result before screening meets the following criteria: liver and renal function tests show ALT or AST > 2 times the upper limit of normal (ULN), or creatinine (Cr) > 1.2 times ULN (refer to the normal reference range of the laboratory at each study center); other clinically significant abnormal laboratory parameters judged by investigators to disqualify subjects from enrollment;
• Allergic constitution, or hypersensitivity to the investigational product Tongluo Kaibi Tablets, pregabalin capsules, excipients or similar ingredients; Suspected or confirmed history of alcohol or substance abuse;
• Pregnant or lactating women, women planning pregnancy in the near future, or those unwilling to adopt contraceptive measures;
• Receiving Tongluo Kaibi Tablets at enrollment;
• Participation in any other clinical trial within 3 months prior to enrollment;
• Any other conditions judged by investigators to render the subject unsuitable for this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tongluo Kaibi Tablet group; Tongluo Kaibi Tablets, 0.9 g per dose, once daily; pregabalin matching placebo, 150 mg per dose, once daily. After one week, the dose of pregabalin matching placebo will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks.	Drug: Tongluo Kaibi Tablet; Tongluo Kaibi Tablet is composed of eight Chinese herbal medicines: Nux Vomica Powder, Radix Cyathulae, Radix Angelicae Sinensis, Flos Carthami, Fructus Chaenomelis, Herba Schizonepetae, Radix Saposhnikoviae and Scorpio. It dispels wind and unblocks collaterals, activates blood circulation and dissipates stagnation. It is indicated for joint pain and swelling caused by intermingled cold-heat complicated with blood stasis obstructing collaterals. Since its launch, it has been widely used in the treatment of rheumatic diseases.
Active Comparator: Pregabalin Capsule Group; Tongluo Kaibi Tablet matching placebo, 0.9 g per dose, once daily; pregabalin capsules, 150 mg per dose, once daily. After one week, the dose of pregabalin capsules will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks.	Drug: Pregabalin capsule; Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the Visual Analogue Scale (VAS) for pain from baseline.	Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.	Baseline, week 4, and week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.	A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.	Baseline, week 4, and week 8.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.	The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.	Baseline, week 4, and week 8.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	Baseline, week 4, and week 8.
The Beck II Depression Inventory (BDI)	The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.	Baseline, week 4, and week 8.
The change of the revised Widespread Pain Index(WPI)from baseline.	The total score of the Widespread Pain Index (WPI) ranges from 0 to 19, corresponding to 19 standard pain sites all over the body. One point is assigned if pain is present at a site within the past week, and zero point if no pain occurs. A higher total score indicates a wider distribution of pain across the body.	Baseline, week 4, and week 8.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Amino Acids, Peptides, and Proteins; Organic Chemicals; Acids, Acyclic; Carboxylic Acids; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Pregabalin
• Other Study ID Numbers: 2022013P7A03

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