A human trial to evaluate the efficacy and safety of Angelica gigas N. extract powder(Nutragen) on joint health

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Angelica gigas N. extract powder(Nutragen) on joint health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004587

Enrollment

Registered

2019-12-30

Start date

2018-11-13

Completion date

Unknown

Last updated

2020-01-14

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

Conditions

None listed

Interventions

Dietary Supplement : - Angelica gigas N. extract powder(Nutragen) group: once a day, 2 tablets once, after dinner, for 12 weeks(900mg/day, 800mg/day for Angelica gigas N. extract powder(Nutragen)) - P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 50-80 years at the screening examination 2) Participants currently with one or both knees pain 3) Participants with 1~2 of Kellgren Lawrence grade(KL grade) 4) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1) Patients with a clinically significant disease requiring treatment (i.e., severe cardiovascular system, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.) 2) Patients who take medicine for joint health and intake health functional food within a month prior to the screening examination 3) Patients with a history of antipsychotic medication use within 2 months prior to the screening examination 4)Patients who have participated in other clinical trials within 3 months prior to the screening examination 5)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
Korean Western Ontario and McMaster Universities Osteoarthritis Index(K-WOMAC) total scores;Visual analog scale(VAS)	—

Secondary

Measure	Time frame
Korean Western Ontario and McMaster Universities Osteoarthritis Index(K-WOMAC) sub-scores: pain, stiffness, function;Physician’s Global Assessment(PGA);Erythrocyte sedimentation rate(ESR)	—

Countries

Korea, Republic of

Contacts

Public ContactJongcheon Joo

Wonkwang University Oriental Medical Hospital, Jeonju

Outcome results