Efficacy and Safety of Porcine Placenta Hydrolysate on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002021

Enrollment

100

Registered

2016-08-18

Start date

2016-05-31

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 : Subjects will be randomized to receive Porcine Placenta Hydrolysate or placebo. Subjects will orally self-administer Porcine Placenta Hydrolysate or placebo, 1capsule per day for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) kupperman index = 30mm 2) Subject who agrees to participate in the study and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1) BMI(Body Mass Index) > 30Kg/m2 2) Hormone therapy within the past 3 months 3) Subject with uncontrolled hypertension (over 160/100mmHg, when measuring after 10 minutes steady) 4) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose) 5) History of drug abuse, or alcoholism 6) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal 7) Subject with serum creatinine = 2 times the upper limit of normal 8) Subject who participated in any clinical trial within 1 month or plan to participate in the other clinical study 9) Inappropriate subject decided by the investigator

Design outcomes

Primary

Measure	Time frame
Kupperman Index	—

Secondary

Measure	Time frame
Markers of bone metabolism;Adverse Event	—

Countries

Korea, Republic of

Contacts

Public ContactHun Choi

Inje University Sanggye Paik Hospital

Outcome results