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A open-label multicenter study on the effect of Jiegu capsule on Soft tissue injury and closed fractures of the four limbs

A open-label multicenter study on the effect of Jiegu capsule on Soft tissue injury and closed fractures of the four limbs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099886
Enrollment
Unknown
Registered
2025-03-31
Start date
2023-09-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue injury. closed fractures of the four limbs(Qi stagnation and blood stasis syndrome)

Interventions

Experimental group:Iegu capsule, oral administration, 2 tablets/time, 2 times/day.

Sponsors

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Soft tissue injury 1.Meet the diagnostic criteria for soft tissue injury; 2.Meet the standard of TCM syndrome differentiation of qi stagnation and blood stasis; 3.Age> 18 years old, male or female; 4.Before the first dose, the disease course was within 48h including the boundary value.; 5.They agreed to participate in this trial and signed the informed consent form. Closed fracture of the extremities: 1.Meet the diagnostic criteria for closed fracture of limbs; 2. Meet the standard of TCM syndrome differentiation of qi stagnation and blood stasis syndrome; 3.Age> 18 years old, male or female; 4. Fresh limb fractures with the course of the disease within 2 weeks; 5. Upper limb fracture such as ulna fracture, radius fracture, humerus fracture, etc.., lower limb fracture such as femur fracture, tibia fracture, fibula fracture, etc..; 6. Those who reach the standard of functional reduction by manual reduction or within 48h after internal fixation surgery; 7. They agreed to participate in this trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: Soft tissue injury: 1.known or suspected allergy to any component of the capsule. 2.Large area of soft tissue defect needs skin grafting or flap transplantation surgery, and soft tissue infected patients. 3.The spine, scapula, metacarpal finger, metatarsal, phalanges and other soft tissue injuries that are not easy to measure the site of limb swelling and ecchymosis. 4.Women in pregnancy and lactation. 5. Other circumstances that the investigator considers unsuitable to participate in the trial. Closed fracture of the extremities: 1.known or suspected allergy to any component of the capsule. 2.Pathological fracture caused by bone disease benign or malignant tumor, tuberculosis, osteomyelitis, endocrine metabolism and other factors.. 3.Women in pregnancy and lactation. 4.Other circumstances that the investigator considers unsuitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
/Primary indicator;Fracture healing rate;

Secondary

MeasureTime frame
Single symptom of TCM;VAS scores for pain;Fracture X-ray callus score;

Countries

China

Contacts

Public ContactXiaolong Lu

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

1730657921@qq.com+86 137 8721 3890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026