Randomized controlled clinical study on direct current biostimulation therapy in HR-HPV infection

Efficacy and safety of direct current biostimulation therapy in HR-HPV infection among women: a pilot, randomized controlled clinical study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600120992

Enrollment

Unknown

Registered

2026-03-24

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR-HPV infection

Interventions

Experimental group:Direct current stimulation therapy

Control group:observation and follow-up

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years with a history of sexual activity. 2. HR-HPV positive as detected in this center, with normal cytology or biopsy-confirmed lesion <= LSIL/CIN1, and the time from this detection to enrollment does not exceed 3 months. 3. History of prior HR-HPV infection (any subtype), with the time since this detection exceeding 6 months. 4. Signed informed consent, ability to comply with the study procedures, willingness to complete the 6-month follow-up, and use of effective contraception during the study period.

Exclusion criteria

Exclusion criteria: 1. Receipt of any local or systemic medication for cervical HPV infection or cervical lesions (including but not limited to: interferons, Baofukang suppositories, traditional Chinese medicine suppositories, etc.) within 3 months prior to enrollment. 2. History of any prior physical therapy for the cervix (including but not limited to: photodynamic therapy, laser, cryotherapy, etc.). 3. History of cervical surgery or pelvic radiotherapy. 4. Current or past history of CIN2, CIN3, cervical carcinoma in situ, or cervical cancer. 5. Currently pregnant or breastfeeding, or planning to become pregnant within the next 6 months. 6. Complicated by acute genital tract infection or abnormal vaginal bleeding. 7. Complicated by severe internal medical diseases, or use of immunosuppressants or glucocorticoids within the past 3 months or requiring such medications during the study period. 8. Complicated by severe motor or cognitive dysfunction, rendering the patient unable to comply with the study.

Design outcomes

Primary

Measure	Time frame
HR-HPV overall clearance rate;	—

Secondary

Measure	Time frame
HPV16/18 clearance rate;Vaginal pH value;p16/ki-67;Safety and tolerability;	—

Countries

China

Contacts

Public ContactZhijing Sun

Peking Union Medical College Hospital

sunzhj2001@sina.com+86 10 69156204

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026