CTRI/2023/07/054992尚未招募3 期
An Open Label, Prospective, Non-Comparative, Non-Randomised, Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Kesh21 Hair Oil of OnTop Pharmaceuticals Pvt. Ltd. in Hair Growth Potential and Improvement in Hair Health in Adult Volunteers - NI
OnTop Pharmaceuticals Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Clinically healthy adults subjects between the ages 21 and 55 years (both ages and genders inclusive) looking to improve their hair growth potential.
- •2.Subjects who agree not to dye/color, cut/trim, perming, straightening or other cosmetic treatments and /or undergo any hair treatments not limited to hair spa at beauty saloons/parlours for the duration of participation in the clinical study.
- •3.Subjects with complaints of non-associated excessive hair fall, brittle/thin hair, dull hair, dry/damaged hair.
- •4.Subjects who are willing to abstain from the use of any dedicated products not limited to hair oil, shampoo, conditioner, hair mask, hair serum, hair treatments and home remedies to improve hair fall and other hair health parameters.
- •5.Subjects who are willing to abstain from the use of any oral /topical medications not limited to collagen, biotin supplements indicated and improving hair fall and other hair health parameters.
- •6.Subject who are willing to give informed consent for participation, able to comprehened and understand the responsibilities during screening and treatment period.
- •7.Subjects who are willing not to participate in any other clinical trail during participation in the current trail.
排除标准
- •1.Subject with known hypersenstivity to the ingredients of the investigational product.
- •2.Subjects who had an active trichological procedure done upto 3 months prior to screening
- •3.subjects who have dyed their hair upto 30 days prior to screening.
- •4.Subjects who have scalp conditions not limited to seborrheic dermatitis, psoriasis, alopecia areata, significant scalp scarring that prevents proper examination or evaluation of study criteria
- •5.Subjects with trichotillomania
- •6.Subjects who have anemia or iron deficiency
- •7.Subjects who have previously undergone hair transplantation
- •8.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •9.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •10.Subjects suffering from /on remission from cancer of any type less than 5 years at the time of screening
- •11.Subjects who are planning a pregnancy and /or currently breastfeeding.
- •12.Subjects who have participated in a clinical study less than 1 month before screening.
- •13.Any significant medical condition (eg., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/ poorly controlled or other factors (eg ., planned relocation ) that the investigator felt would interfere with study evaluations and study participation.
- •14.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol
- •15.Subjects who in the opinion of the investigator are not eligible for enrolment in the study.
研究者
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