Effectiveness of natural oil in the treatment of foot corn and calluses
- Conditions
- Health Condition 1: L84- Corns and callosities
- Registration Number
- CTRI/2018/10/016084
- Lead Sponsor
- Gods Own Store LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Resolution or change in number and/or sizes of foot corn and calluses as assessed by physical examination; <br/ ><br>2.Effect of treatment in hydration, elasticity and skin surface texture at and around affected area as assessed by physical examination; and <br/ ><br>3.Relief in pain and discomfort as assessed by subject interview. <br/ ><br>Timepoint: Day 0 <br/ ><br>Day 14 <br/ ><br>
- Secondary Outcome Measures
Name Time Method The secondary endpoints comprise of the safety analyses including Adverse events, Allergic Reaction.Timepoint: Day 0 <br/ ><br>Day 14 <br/ ><br>