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Not yet recruitingNCT05933486Updated Jul 6, 2023

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

A Phase 4 interventional study of Tongluo-Kaibi tablet plus placebo of pregabalin and placebo of Tongluo-Kaibi tablet plus pregabalin in Fibromyalgia Syndrome, sponsored by Quan Jiang. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-06.

Sponsored by Quan Jiang · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fibromyalgia Syndrome

Keywords

  • Tongluo-Kaibi Tablet
  • Traditional Chinese Medicine
  • Fibromyalgia Syndrome
03

In context

Fibromyalgia

1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Quan Jiang is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Tongluo-Kaibi tablet plus placebo of pregabalin

    Drug: Tongluo-Kaibi tablet plus placebo of pregabalin

  • Active comparator
    placebo of Tongluo-Kaibi tablet plus pregabalin

    Drug: placebo of Tongluo-Kaibi tablet plus pregabalin

Interventions

  • DrugTongluo-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.

  • Drugplacebo 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.

06

What researchers measure

Primary outcomes

  1. VAS

    Visual Analogue Score

    Time frame: 8 weeks

Secondary outcomes

  1. MFI-20

    Multidimensional Fatigue Inventory

    Time frame: 8 weeks

  2. BDI

    Beck Depression Inventory

    Time frame: 8 weeks

  3. PSQI

    Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

  4. WPI

    Widespread Pain Index

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05933486
Lead sponsor
Quan Jiang
Responsible party
Quan Jiang (chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Sponsor-investigator
First posted
Jul 6, 2023
Start date
Sep 2023 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jul 6, 2023

Study contacts

Quan Jiang
Contact
doctorjq@126.com
+8613901081632

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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