CTRI/2018/10/016084尚未招募4 期
A prospective, single arm study to assess the efficacy and safety of natural oil in treatment of foot corn and calluses.
Gods Own Store LLP0 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
- 4 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
- Pms
入排标准
入选标准
- •1.Participants must be adults, aged 18-45 years old.
- •2.Females Subjects must have a negative pregnancy test. Pregnant patients or breast feeding will be excluded from the study.
- •3.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
- •4.Participants must be willing to apply the test product and return for assessment visits for evaluation.
- •5.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications that has not been recommended by the study physician.
- •6.Participants must agree to take healthy diet and life style.
排除标准
- •1.Participants with plantar calluses that have been treated within past six months.
- •2.Single or married subjects who are pregnant or have borne children in past one year.
- •3.Participants with a current foot skin disorders other than corn and calluses such as infections (athleteâ??s foot), dermatitis, psoriasis, unhealed skin wounds, ulcers or blisters.
- •4.Participant with evidence of concurrent disease that exclude administration of therapy as outlined by the study protocol.
- •5.Participant with history or presence of systematic disease, including peripheral vascular disease or a musculoskeletal disorder of the foot or ankle, rheumatoid arthritis or diabetes.
- •6.Subjects who, in the opinion of the investigator, abuse alcohol or drugs.
- •7.Subjects who are unable to reach feet to apply product.
- •1.Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician 48h prior initiating the study or during the study.
- •2.Participant who stop taking the product mid-study.
- •3.Participant with known allergies to the main components of the test product or placebo.
- •4.Participation in another clinical trial or taking an investigational product in the past three months
- •5.Any participant who is not able to give informed consent.
研究者
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