Skip to content

A randomized controlled study of the efficacy and safety of orthopedic water in the treatment of acute ankle sprains

A randomized controlled study of the efficacy and safety of orthopedic water in the treatment of acute ankle sprains

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000911
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

acute ankle sprain

Interventions

Futalin Group:Diclofenac diethylamide emulsion apply this emulsion to the affected area according to the size of the painful area. Gently massage the affected area for 2 minutes and rub gently so that
Yunnan Baiyao Group:Press the spray button directly and spray the affected area 3 times a day. For heavy injury, spray the insurance solution first, with the nozzle 5 to 10 centimeters from the skin,
orthopedic water group:Using the nozzle that comes with the Ortho Water bottle spray the solution 3 onto the affected area 3 times a day for 7 days.

Sponsors

Dongzhimen Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 80 years old gender is not limited. 2) There is an obvious history of ankle sprain. 3)After the injury there is obvious pain swelling and difficulty in standing and walking in the ankle joint. 4) Positive anterolateral talar palpation test and positive reverse anterolateral drawer test. 5) If the ankle sprain is graded at moderate or above. 6) Fractures were excluded from ankle joint frontal and lateral radiographs. 7)Patients voluntarily participated in this clinical trial and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1)Ankle sprain that has lasted for more than 2 weeks. 2) Those with localized skin breakdown of ankle sprains. 3)Those who are known to be allergic to the components of the test drug. 4)Those who have used any anti-inflammatory analgesic or blood-stasis activating drugs before enrollment including but not limited to Analgesics non-steroidal anti-inflammatory drugs COX-2 inhibitors opioids Chinese patent medicines for activating blood circulation and removing blood stasis and Chinese patent medicines for relaxing tendons and collaterals. and Chinese patent medicines that promote blood circulation and eliminate blood stasis. 5) People with serious heart brain lung liver and kidney diseases; people with serious blood system diseases; people with bleeding tendency; people with autoimmune diseases. 6) People with diabetes mellitus and poor blood sugar control. 7) Those who have a history of drug abuse and are unable to quit. 8) Those with schizophrenia or obvious mental disorder and poor compliance. 9)Pregnant or lactating women or those who are unwilling to use an effective method of contraception during the study and for 6 months after the end of study treatment. use an effective method of contraception. 10)Participating in another clinical trial or have participated in a clinical study of another drug within 1 month. 11) Patients who in the judgment of the investigator are not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Visual analog scale scores;

Secondary

MeasureTime frame
recovery time;Degree of swelling reduction;Complication rate;Health economics indicators;Ankle Function Score;

Countries

China

Contacts

Public ContactSun Qi

Dongzhimen Hospital of Beijing University of Chinese Medicine

sunqi2001@sina.com13552777065

Outcome results

None listed

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