Health TrialsbyHealthPanel

Effect of Honey For CIN II

ConditionsCervical Intraepithelial Neoplasia-IIHigh Risk Human Papillomavirus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorZuyderland Medisch Centrum

About this trial

The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women 18-40 years

Primary CIN II confirmed histologically in the biopsy on colposcopic examination

Sufficient mastery of the Dutch language

Disqualifiers

Simultaneous abnormality in columnar epithelial cells (AIS).

Hr-HPV negative cytology

Immunosuppressant use/Autoimmune disease (HIV, CVID)

History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)

Trial design

Design model

Single group

Treatments tested in this trial

  • Medical grade honey formulation (MGH) (L-Mesitran®)

    Drug

    Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Medical grade honey formulation (MGH) (L-Mesitran®) for CIN IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clearance of hr-HPV

The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus

Time frame
6 months

Secondary outcomes

1

Regression of CIN II

Defined as a regression to Pap 1

Time frame
12-24 months
2

Clearance of hr-HPV and normalization of cytology (KOPAC)

Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).

Time frame
12-24 months
3

Characteristics of the vaginal microbiome

Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures

Time frame
0-6 months
4

Cervical immune status

Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells

Time frame
0 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zuyderland Medisch Centrum

Lead sponsor

Source ClinicalTrials.gov
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