Health Condition 1: null- Cervical infection with Human Papilloma Virus (HPV)
Conditions
Interventions
Intervention1: Basant cream (5ml): will receive the assigned treatment every night for 30 applications, excluding menstruation days (one application per day at bed time)
Intervention2: Curcumin soft g
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: �� Subjects willing to provide written informed consent for participating in the study �� Females with HPV infection in uterine cervix, aged between 30 to 65 years and whose spouse is willing to use barrier method contraception during the study period �� Subjects with laboratory tests within normal limits �� Subjects with negative urine pregnancy test* �� Subjects able to comprehend all study procedures and likely to be able to comply with the requirements of the protocol, in the opinion of the Investigator. * Urine pregnancy test should be performed for all eligible subjects in the reproductive age group with the exemption of subjects who are surgically sterile or have attained menopause (if they had their last menstruation more than 2 years back).
Exclusion criteria
Exclusion criteria: Pregnant and lactating women Subjects with history of cancer and menstrual flow more than 7 days High grade SIL either on cytology, colposcopy or histology Subjects with history of hypersensitivity/ allergic reactions to the study medication or to any excipients of the product Clinical evidence of any serious systemic disease and acute illness, in the clinical opinion of the Investigator Subjects who were previously included or had participated in any other clinical study within 30 days prior to the date of consent Subjects who are scheduled for surgery within 7 days from study completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination of HPV from cervical cells of subjects. Subjects will be followed for tolerance and adverse effects, if any through questioning and clinical examinationTimepoint: based on molecular detection of HPV after 30 applications of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Reduction in viral load by at least 50% of the baseline. â?¢Improvement in lesion on cytology if previous cytology was abnormal. â?¢Improvement in lesions on colposcopic examinations and /or biopsy if these tests were abnormal before treatmentTimepoint: From baseline to end of treatment (i.e. after 30 applications) | — |
Countries
India
Contacts
Public ContactRakesh Naranbhai Dhadania
Director
Outcome results
None listed