Multi-center clinical trial to assess efficacy of acupuncture and Dang Gui Xu San extract granules combination treatment for ankle sprain

A randomized, double-blind, placebo-controlled, multi-center pilot clinical trial to evaluate the efficacy and safety of Dangguixu-san(Carecon capsule) on ankle sprain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002374

Enrollment

Registered

2017-07-11

Start date

2017-06-30

Completion date

Unknown

Last updated

2019-06-17

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

Conditions

None listed

Interventions

Drug : Clinial trial medicine : Dangguixu-san(Carecon capsule) and Placebo Volume : 3 capsule for one time Count : 3 times for one day Period : 7 days Route : Oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) People over the age of 19 who sprained lateral ankle joint(Grade ?or?) within 72 hours 2) People who have sufficient cognitive function and have voluntarily signed the agreement

Exclusion criteria

Exclusion criteria: 1) Ankle fracture on X-ray 2) Grade? or severe damage which requires surgery 3) Previous ankle fracture on same injured joint within 1 year 4) Severe diseases (cancer, kidney disease, liver disease, neurological disease, blood coagulation disease, dementia) 5) Neurological disorder on damaged lower extremity including motor disturbance or sensory loss 6) Pregnant or possible pregnant woman, lactating woman 7) Patient who took NSAID, painkiller, steroids to control pain after injury (exception: use of pain relief patch on the screening day) 8) Impaired liver function (ALT over 80 IU/L), impaired kidney function (Creatinine over 2 mg/dl) 9) Patient who are deemed to be unsuitable due to the result of past tests or has historical history which may negatively affect the test 10) Patient who has genetic disorder such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 11) Patients with allergic reaction to clinical trial drug ingredients 12) Patients who participated in other clinical trials within 4 weeks or have participating in another clinical trials

Design outcomes

Primary

Measure	Time frame
Visual analogue scale of ankle pain	—

Secondary

Measure	Time frame
Foot and Ankle Outcome Score(FAOS);Ankle Edema(Figure of eight method);European Quality of Life Five Dimension. Five Level Scale(EQ-5D-5L);Number of recurrent ankle injuries	—

Countries

Korea, Republic of

Contacts

Public ContactChamkyul Lee

Semyung University

leetaeho0331@hanmail.net+82-43-841-1738

Outcome results