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A Phase IIa clinical trial for Xiaotong Aerosol in the treatment of acute soft tissue injury (ankle sprain)

A Randomized, multi-dose exploration, positive drug (original dosage form) parallel control, multicenter trial for the efficacy and safety of Xiaotong Aerosol in the treatment of Acute soft tissue injury (ankle sprain) (qi stagnation and blood stasis syndrome)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026496
Enrollment
Unknown
Registered
2019-10-12
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Acute soft tissue injury (ankle sprain) (qi stagnation and blood stasis syndrome)

Interventions

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Comply with the diagnostic criteria for ankle sprain, graded as type I or type II; (2) TCM syndrome differentiation is qi stagnation and blood stasis syndrome; (3) Aged 18 to 65 years old (including the boundary value); (4) The time from the onset to the first visit does not exceed 48 hours; (5) pain symptom VAS score >=40mm; (6) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients requiring orthopedic or surgical treatment; (2) Patients have suffered damage within 3 months of the same target target site; (3) Patients are 3 or more injuries in the same part within 12 months before the injury; (4) The sprained ankle joint has undergone surgery; (5) After the onset of the disease, the sprained ankle joint received acupuncture, physiotherapy, massage and other treatments; (6) Patients with skin trauma at the site of treatment, patients with poor skin condition, and patients with skin irritation; (7) Using anti-inflammatory and analgesic drugs such as non-steroidal anti-inflammatory drugs or traditional Chinese medicines for promoting blood circulation, relieving swelling and relieving pain, within 12 hours before enrollment; (8) Combined fracture, infection, tumor, joint dislocation, severe open injury of soft tissue, and nerve, blood vessel, important muscle, organ injury; (9) Severe cardiovascular disease, liver disease (ALT, AST >=2 times the upper limit of normal value), kidney disease (Scr> upper limit of normal value), blood disease (coagulation abnormality has clinical significance, hematopoietic dysfunction, spleen function) Patients with hyperthyroidism, bleeding tendency, etc.), infectious diseases, tumors and other serious comorbidities; (10) Patients can not cooperate with the completion of clinical trials; (11) Patients are unable to follow the prescription according to the plan and return to the hospital on time, etc., who believe that the compliance is poor; (12) Pregnant or pregnant women, as well as lactating women; (13) Patients are participating in or participating in other drug clinical trials within one month; (14) Patients are allergic to the relevant components of the test drug, emergency drug (celecoxib capsule) and sulfonamides; (15) Other circumstances that the investigator believes are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Pain VAS score;

Secondary

MeasureTime frame
Area under the pain curve;Tenderness VAS score;Clinical efficacy (clinical cure rate, significant efficiency, efficiency);TCM syndrome score;Single symptom score;Takakura ankle score;

Countries

China

Contacts

Public ContactYang Kexin

Wangjing Hospital, China Academy of Chinese Medical Sciences

1052113634@qq.com+86 010-84739194

Outcome results

None listed

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