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Clinical of a HERBAL FOOT CREAM in Personal Care, dryness and skin safeness

Phase 2
Registration Number
CTRI/2020/10/028505
Lead Sponsor
SANGHVI BEAUTY AND TECHNOLOGIES PRIVATE LIMITED
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Healthy male and female volunteers between 18 to 50 years of age.

2. Volunteers must be in good health.

3. Volunteers must have read and signed the Informed Consent Form.

Exclusion Criteria

1. A current skin disease of any type like eczema, psoriasis, dermatitis etc.

2. Known sensitivity to the intervention constituents.

3. Pregnant or lactating female volunteer.

4. Participation in a clinical study in the past thirty days or current participation in another similar clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Improvement in included parameters like softness, smoothness, cleanliness, moisturizing effect on feet and decrease in cracks, roughness, pain, scaling, Pruritus of the feet. <br/ ><br>2. The subject will also be evaluation in terms of lakshanas (symptoms) defined according to Ayurvedic principles. These parameters were scored as poor, fair, good, very good, and excellent as per predefined visual analogue scale (VAS).Timepoint: Screening, 7th day and 14th day
Secondary Outcome Measures
NameTimeMethod
Assessment of incidence of adverse events and patient compliance to the therapy like Irritation, Erythema, Edema and Urticaria and specific complications defined in Ayurveda. <br/ ><br>Timepoint: Screening, 7th day and 14th day
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