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

13. juli 2026 opdateret af: Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Aktiv komparator: 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.
Medicin: Pregabalin kapsel
Pregabalin er en af ​​de tre lægemidler (pregabalin, duloxetin og milnacipran), der er godkendt af Food and Drug Administration (FDA) til behandling af fibromyalgi i USA, og den eneste medicin, der er godkendt i Kina.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Tidsramme: Baseline, week 4, and week 8
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
Baseline, week 4, and week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Tidsramme: Baseline, week 4, and week 8.
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.
Tidsramme: Baseline, week 4, and week 8.
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.
Tidsramme: Baseline, week 4, and week 8.
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)
Tidsramme: Baseline, week 4, and week 8.
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.
Tidsramme: Baseline, week 4, and week 8.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Faktiske)

31. oktober 2025

Studieafslutning (Faktiske)

1. marts 2026

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2022013P7A03

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Fibromyalgi syndrom

Kliniske forsøg med Pregabalin kapsel

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