Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome

NCT07708948 | Completed Phase 4

• 1 other identifier: 2022013P7A03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.

  Baseline, week 4, and week 8.

• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.

  Baseline, week 4, and week 8.

• The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.

  Baseline, week 4, and week 8.

• The Beck II Depression Inventory (BDI)

  Baseline, week 4, and week 8.

• The change of the revised Widespread Pain Index(WPI)from baseline.

  Baseline, week 4, and week 8.

Study Arms (2)

Tongluo Kaibi Tablet group

EXPERIMENTAL

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

Pregabalin Capsule Group

ACTIVE COMPARATOR

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

Interventions

Tongluo Kaibi Tablet DRUG

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.

Tongluo Kaibi Tablet group

Pregabalin capsule DRUG

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.

Pregabalin Capsule Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: January 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: March 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)