Clinical Trial: Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Randomized, Double Blind, Placebo Control, Parallel Design, Phase 2a Trial to Evaluate the Efficacy and Safety of PGA (Poly-gamma Glutamic Acid) for the Fertile Women With
Brief Summary: The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
Detailed Summary:
This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group.
The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.
The control group will be observed for 12 weeks without any comparator.
Sponsor: BioLeaders Corporation
Current Primary Outcome: Regression rate [ Time Frame: up to 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reid Colposcopic Index [ Time Frame: up to 12 weeks ]Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
- Pap smear test [ Time Frame: up to 12 weeks ]Result of Pap smear test will be assessed at the time of screening and 12 weeks.
- HPV (Human Papilloma Virus) DNA Test [ Time Frame: up to 12 weeks ]Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.
- HPV (Human Papilloma Virus) Hybrid CaptureII Test [ Time Frame: up to 12 weeks ]Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.
- NK (Natural Killer) Cell Activity [ Time Frame: up to 12 weeks ]Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
- Peripheral Blood Mononuclear Cells (PBMCs)Test [ Time Frame: up to 12 weeks ]Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
Original Secondary Outcome: Same as current
Information By: BioLeaders Corporation
Dates:
Date Received: March 29, 2013
Date Started: June 2013
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016