A phase II, randomized, multicentric, placebo controlled study on the clearance of human papilloma virus (HPV) infection in uterine cervix by Basant (a polyherbal cream) and curcumin soft gelatin capsule in females infected with HPV

Department of Biotechnology0 个研究点目标入组 280 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•&#56256;&#56451; Subjects willing to provide written informed consent for participating in the study
•&#56256;&#56451; 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
•&#56256;&#56451; Subjects with laboratory tests within normal limits
•&#56256;&#56451; Subjects with negative urine pregnancy test*
•&#56256;&#56451; 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).

•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

发起方

Department of Biotechnology