Effect 0f a herbal face gel on skin hydration.

Completed

• Conditions: Subjects with dry skin

• Registration Number: CTRI/2019/03/018233
• Lead Sponsor: Ramaiah Indic SPecialty Ayurveda

Brief Summary

This is a prospective open labelclinical study to assess the effectiveness of the herbal face gel inmoisturizing and enhancing skin health.  Baseline history will be obtained in order todetermine the subject’s eligibility for enrolment in the study. The baselineassessment will include personal data, a description of symptoms and details ofpast medical history, history of possible exacerbating factor/s, etc.

A total of 50 subjects will berecruited, of which data of at least 40 completed subjects will be used to drawthe result and the statistics. On recruitment, the case record proforma will becompleted with thorough examination for Ayurveda parameters includingDashavidha pariksha. Prakriti will be assessed using the TNMC Questionnaireduring the recruitment as it would help to understand the effectivenessspecific to prakriti. Outcome assessments before, during and after the studywill be done by a senior Ayurveda clinician at RISA, who is not a part of theresearch team.

Subjects will be given aconditioning phase for 7 days at entry. Following this, they will be given the herbalface gel and instructed to apply 1gm quantity of the gel all over theface, gently rubbing it in, till the gel gets absorbed. The second applicationwill be done with a time gap of 8 hours. A demonstration of the procedure willbe given at site. Subjects will apply twice daily, for a period of 30days, witha visit to RISA after 15 and 30days. Subjects will be asked to return the oldtubes at the final visit, in order to monitor their use. Subjects will not beallowed to use any other cosmetic product, such as gel, cream, lotion, or milkon the face, other than Lux soft touch soap as daily wash. Skin moisturization will be measured byclinical assessment by a senior Ayurveda clinician at RISA, who is not a partof the research team. Secondary changes will be assessed using a self-perceivedskin health satisfaction questionnaire. All the subjects will be given a smalldiary to make a note of the product use so as to monitor the compliance.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Study Completion: 2019-08-06
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Male and female healthy volunteers, with age 18–45 years 2.Subjects willing and able to provide informed consent voluntarily 3.
• Subjects having normal to moderate dry skin as assessed on the 4-point scale given below 4.Willing to maintain the investigational product use throughout the study.
• 5.Subjects who have not undergone any skin therapy (eg.
• De-tan, etc.) in last 3 months 6.Subjects with no known allergy to any of the test ingredients 7.Subjects who are willing to refrain from using any skin care product for the face other than the investigational product, like, moisturizers, lotions and face creams, for the duration of the study 8.Subjects willing and able to comply with all trial requirements.
• 9.Laboratory workup within normal limits; including complete hemogram, glucose, blood urea nitrogen, creatinine, liver function test, lipid profile, thyroid-stimulating hormone, urine pregnancy test.

Exclusion Criteria

• 1.Subjects who have skin diseases like psoriasis, atopic dermatitis , severe dry, self-approved acne etc.
• at the time of screening 2.
• Subject with chronic systemic illnesses or treatment that can affect skin health eg.
• Dialysis 3.Subjects on oral medications or suffering from chronic illness which will compromise the study 4.Subjects who have participated in a similar investigation in the past four weeks 5.Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the moisturization of the skin will be assessed by the senior Ayurveda clinician using a 4-point scale-overall dry skin score.	At the end of 30 days

Secondary Outcome Measures

Name	Time	Method
A self-perceived skin health satisfaction questionnaire will also be administered to the subjects at baseline and at the end of the study.	at the end of 30 days

Trial Locations

Locations (1)

Ramaiah Indic specilaty Ayurveda restoration clinic; 🇮🇳 Bangalore, KARNATAKA, India

Ramaiah Indic specilaty Ayurveda restoration clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Suprabha Hegde

Principal investigator

8722810753

drprabha2u@gmail.com