Perilla frutescens extract on degenerative arthritis

12 weeks, ramdomized, double-blind, placebo-controlled crinical trial for the evaluation of the efficacy and safety of complex of Perilla frutescens extract on degenerative arthritis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002175

Enrollment

Registered

2016-12-23

Start date

2015-12-29

Completion date

Unknown

Last updated

2019-03-11

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 : take a 1000 mg capsule of active medication(containing 250 mg of Perilla frutescens extract complex in a capsule) or soybeen oil 1capsule though randomaization twice daily for 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Male and female aged between 40 years and 75 years 2) Subject with 30 mm or greater on VAS 3) Subject with Kellgren and Lawrence grade I or II on knee or hip joint 4) Subject who signed an informed consent form prior to the study

Exclusion criteria

Exclusion criteria: 1) Subject with other than degenerative arthritis determined by investigator 2)Subject whose joint space is decreased by more than 2mm 3) Subject with moderate arthritis accompanied by bone spurs around joint, irregular articular surface, chondrogenesis, and bone cyst 4) Subject with clinically significant cardiovascular, immunization, infective, or neoplastic diseases 5) Subject being treated for gastritis or gastric ulcer 6) Subject with uncontrolled hypertension (over 160/100mmHg measured at screening) 7) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose measured at screening) 8) Subject with TSH = 0.1 µIU/ml or = 10 µIU/ml 9) Subject with AST(GOT) and ALT(GPT) = 3 times the upper limit of normal 10) Subject with Creatinine = 2 times the upper limit of normal 11) Subject who is pregnant or planning to pregnant within 3 months 12) Subject administered medication or health functional foods related to arthritis within 1 week of screening 13) Subject administered medicinal herbs or foods containing of main components of Perilla frutescens and Atractylodes macrocephala Koidzumi within 1 week of screening 14) Subject with severe mental illness 15) Subject planning to participate in the other clinical trial 16) Subject participated in any clinical trial within 3 month 17) Inappropriate subject decided by the investigator 18) Subject allergic to main components (Perilla frutescens and Atractylodes macrocephala Koidzumi)

Design outcomes

Primary

Measure	Time frame
survey VAS;Korean - Western Ontario McMaster Universities Osteoarthritis ;Inflammation of blood; improvement of patients and investigator	—

Secondary

Measure	Time frame
Adverse Reactions, Clinical Laboratory, electrocardiogram;Clinical Laboratory; electrocardiogram	—

Countries

Korea, Republic of

Contacts

Public Contactyun KIM

Inje University Seoul Paik Hospital

Outcome results