A human study of herbal complex extract NS2107 on climacteric symptoms in menopausal women

A human study to evaluate the efficacy and safety of extracts of Agrimonia pilosa L. and Salvia miltiorrhiza Bunge on arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007206

Enrollment

Registered

2022-04-18

Start date

2021-07-09

Completion date

Unknown

Last updated

2022-10-24

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 : Treatment group: 2 capsules, once a day (570 mg as Agrimonia pilosa L. and Salvia miltiorrhiza Bunge extract) Control group: 2 capsules, once a day (0 mg as Agrimonia pilosa L. a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects who voluntarily agree to participate and signs informed consent form 2) Adults more than 50 years old 3) Subjects who suffer from knee osteoarthritis

Exclusion criteria

Exclusion criteria: 1) Subjects who took nonsteroidal anti-inflammatory drugs(NSAID) or steroid-based medications within one week of the first visit 3) Inflammatory osteoarthritis (increase of ESR 4) BMI = 30 5) Other nervous system or lower limb abnormality such as hip joint or foot joint that can disturb gait 6) Surgery on knee joint 7) More than moderate degree of back pain or radiating pain in lower limbs 7) Severe neurological or vascular diseases in lower limbs 8) AST(GOT) or ALT(GPT) level over 3 times of the upper limit of normal range 9) Creatinine level over 1.5 times of the upper limit of normal range 10) Subject diagnosed with dementia or intellectual disability or who is illiterate 11) Continuous consumption of health functional food that affect osteoarthritis within 4 weeks before the first visit 12) Those who participated in other clinical trials within a month 13) Pregnant women or lactating women or persons planning to become pregnant 14) Subject who has hypersensitivity to ingredients contained in test food or placebo or has experienced severe food allergy reactions 15) Subjects who are deemed to be inappropriate to this study

Design outcomes

Primary

Measure	Time frame
Visual analogue scale;Western Ontario and McMaster University Osteoarthritis Index	—

Secondary

Measure	Time frame
Radiographic assessment;Biomarkers;Blood, urine test	—

Countries

Korea, Republic of

Contacts

Public ContactJu Eun Paek

BiofoodCRO

jepaek@biofoodcro.co.kr+82-2-362-0838

Outcome results