MedPath

To evaluate the Skin health enhancing ability of Kapiva Skin Foods Glow Mix- An Ayurvedic powder-based drink in healthy adult female face ski

Phase 4
Registration Number
CTRI/2023/07/054901
Lead Sponsor
Adret Retail Pvt. Ltd. (Kapiva Ayurveda)
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. Female adult subjects in general good health & age group of 30 to 50 years.

2. Subject must not have used any anti-aging cream before study enrolment and intend to use during the study.

3. Subject who agrees not to use any other product/treatment/home

remedy/soap bar on their face during the study period other than the test product.

4. Subject with Fitzpatrick skin types III to V.

5. Subjects having visible fine lines and wrinkles in periorbital area like Crow’s feet-under eye & forehead as assessed by dermatologist.

6. Subjects having skin aging concerns as assessed by dermatologist

7. Subjects not having hair style which covers almost the entire forehead.

8. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.

9. Subjects who agree not to carry out bleaching or any other procedures on face during the study period.

10. Subjects who agree not to expose to excessive sun light (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).

11. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.

12. Subjects willing to abide by and comply with the study protocol.

13. Subjects who have not participated in a similar investigation in past four weeks.

14. Subjects who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria

1. Subjects using any anti-aging cream prior to study enrolment and intend to use during the study.

2. Subject with any other signs of significant local irritation or skin disease.

3. Subjects who experience nausea or vomiting due to the flavor or product will be excluded from the study

4. Subject currently taking any medication including food supplements, which the Investigator believes may influence the interpretation of the

data.

5. Subjects showing abnormal levels in blood test parameters. (Subjects having abnormal values but are clinically fit to participate in the trial

would be enrolled in the study at Principal Investigator’s Discretion).

6. Subject having chronic illness or had major surgery in the last year.

7. Subjects undergoing any treatment of any skin condition on their face/forearm/any.

8. Subjects not willing to discontinue other topical facial products.

9. Subjects with clinically significant cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital, or any other systemic

condition requiring therapeutic intervention.

10. A known history or present condition of an allergic response to pharmaceutical products its components or ingredients in the test products.

11. Pre-existing systemic disease necessitating long-term medications.

12. Genetic and endocrinal disorders.

13. Pregnant and lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in spots, pigmentation, wrinkles & fine lines. <br/ ><br>Subject photographs will be takenTimepoint: Day 1, Day 15, Day 30, Day 45, Day 60, Day 75 & Day 90
Secondary Outcome Measures
NameTimeMethod
Subject photographs will be takenTimepoint: Day 1, Day 15, Day 30, Day 45, Day 60, Day 75 & Day 90
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