B-Vitamin mixture improves the effect of nonsteroidal anti-inflammatory drug in patients with painful foot and ankle conditions; a multi-centered, prospective, randomized, controlled trial

B-Vitamin mixture improves the effect of NSAID in patients with painful foot and ankle conditions; a multi-centered, prospective, randomized, controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005035

Enrollment

200

Registered

2020-05-19

Start date

2020-10-14

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Drug : Control group: Airtal, 1 tablet, 2 times a day, total 4 weeks, oral administration Test group: Airtal and Impactamine power, 1 tablet, 2 times a day, 4 weeks in total, oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients between 19 and 80 years of age, with one of the following chronic inflammatory disease, who requires an administration of a nonsteroidal antiinflammatory drug due to pain greater than visual analogue scale 40/100, ? Osteoarthritis of foot and ankle ? Plantar fasciitis ? Achilles tendinitis ? Interdigital neuroma

Exclusion criteria

Exclusion criteria: ? Those whose initial pain level is less than visual analogue scale 40/100 ? Those who have taken non-steroidal anti-inflammatory drugs or other painkillers within the last week ? Those who have been diagnosed with depression ? Those who require surgical treatment ? Those with wounds in the lesion area ? Self taking vitamins ? Patients who are continuously being treated for systemic autoimmune disease ? Those who are difficult to understand and understand sufficiently for the explanation of this study, such as illiterate people and foreigners ? Elderly people over 80 ? Pregnant women ? Vulnerable subjects including medical students, trainees or majors, hospital staff, and pharmaceutical company staff.

Design outcomes

Primary

Measure	Time frame
Visual analogue scale(VAS)	—

Secondary

Measure	Time frame
EuroQol-5D (EQ5D);Foot and ankle outcome score(FAOS)	—

Countries

Korea, Republic of

Contacts

Public ContactBom Soo Kim

Inha University Hospital

bskim.md@gmail.com+82-32-890-2916

Outcome results