Evaluation dermal safeness and therapeutic effects of a herbal Body Lotion

A Pilot study to evaluate dermatological safeness and therapeutic effects on application of a HERBAL BODY LOTION- A open level, interventional study.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028514

Enrollment

Registered

2020-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: MyGlamm Wipeout HERBAL BODY LOTION: The interventional product mentioned is a herbal based body lotion containing the the medicinal herb based ingredients Rose Flower Extract, Aloe ver

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects age group 18 - 55 years 2. Healthy male and female subjects 3. Subjects willing to give a written informed consent. 4. Subject has not participated in a similar investigation in the past two weeks. 5. Subjects willing to come for regular follow up. 6. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Skin allergy antecedents or atopic subjects 2. Known medical history of hyper sensitivity to any herbal cosmetic products 3. Severe cutaneous disease, any chronic illness and subjects on oral corticosteroid. 4. Subjects participating in any other cosmetic or therapeutic trial. 5. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 6. Pregnant and breast feeding mothers.

Design outcomes

Primary

Measure	Time frame
1. Evaluation of nourishing, moisturizing and smoothing effects as per clinical scoring systems of EEMCO for overall dry skin score (ODS) and Specified symptom sum score (SRRC) for scales, roughness, redness, and cracks. 2. The subject will also be evaluation in terms of lakshanas (symptoms) defined according to Ayurvedic principles like twakasnehana, kandu etc. as per predefined visual analogue scale (VAS). Â Timepoint: Screening, 7th day and 14th dayÂ	—

Measure

Time frame

1. Evaluation of nourishing, moisturizing and smoothing effects as per clinical scoring systems of EEMCO for overall dry skin score (ODS) and Specified symptom sum score (SRRC) for scales, roughness, redness, and cracks. 2. The subject will also be evaluation in terms of lakshanas (symptoms) defined according to Ayurvedic principles like twakasnehana, kandu etc. as per predefined visual analogue scale (VAS). Â Timepoint: Screening, 7th day and 14th dayÂ

—

Secondary

Measure	Time frame
Assessment of incidence of adverse events and patient compliance to the therapy like Irritation, Erythema, Edema, Pruritus and Urticaria etc.Timepoint: Screening, 7th day and 14th day	—

Countries

India

Contacts

Public ContactRuchita Tripathi Upadhyay

Department of Ayurvedic and Unani Services Uttarakhand

avnishdr@gmail.com09639017857

Outcome results