Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a vaginal gel called CH2 compared to a placebo (a treatment that looks the same but has no active ingredients) on a condition known as Cervical Intraepithelial Neoplasia (CIN1), a mild form of cervical cell changes often related to the human papillomavirus (HPV). The goal is to see if using the CH2 gel can help reduce the CIN1 condition more effectively than doing nothing (the placebo) by looking at how many women’s CIN1 improves, how quickly it improves, and if the HPV clears from their systems.

To participate in this trial, women aged 20 and older who have been diagnosed with CIN1 through a biopsy and are positive for high-risk HPV may be eligible. However, those who are pregnant, planning to become pregnant, have certain allergies or other medical conditions, or cannot use the gel on their own will not qualify. Participants will apply the gel as directed and will be monitored over time to see how their condition changes. This study aims to better understand if this natural gel can support women's health by promoting the healing of cervical changes.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Female individuals aged 20 years (inclusive) or older who have abnormal Pap smear results and have been diagnosed with CIN1 via colposcopy biopsy, and are also positive for high-risk HPV. This includes:
• • Patients with Pap smear results of CIN2, ASCUS, or CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, with pathology confirming CIN1.
• • Patients with Pap smear results of CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, and where the biopsy sample is insufficient for diagnosis or the biopsy pathology is normal.
• Exclusion Criteria:
• • Female patients who are currently pregnant, planning to become pregnant, or are underage.
• • Patients with an allergy to the ingredients in CH2 Natural Purifying Protection Serum.
• • Patients diagnosed with CIN2, CIN3, or higher through colposcopic biopsy.
• • Patients with urinary tract or pelvic infections.
• • Patients with significantly impaired cognitive function.
• • Patients who are unable to self-administer vaginal gel.
• • Patients with immunocompromised conditions, end-stage liver or kidney disease, those using steroids, or those who have previously undergone total hysterectomy.