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Topical Preparation of Pomegranate and Ginkgo Biloba for Anti-aging Activities

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ClinicalTrials.gov Identifier: NCT03772418
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed A. H. Abdellatif, Al-Azhar University

Brief Summary:
As the quality of life improves, people are seeking to look as young as they feel. Ginkgo biloba (GB) and Pomegranate (PG) extract can be used to create efficacious topical anti-aging products. GB & PG are now widely used in research and clinical trials on age-associated diseases, for example, skin aging, brain dysfunction, cardiovascular system diseases, carcinogen metabolism. The investigator's aim is to formulate a topical cream in the form (O/W or W/O emulsion) formulation, containing GB as an anti-aging formulation for the public.

Condition or disease Intervention/treatment Phase
Skin and Subcutaneous Tissue Disorders Drug: Cream Base Drug: Pomegrante and Ginkgo biloba group Phase 1

Detailed Description:
In this study, a vanishing cream will be prepared by reaction of a stearic acid with alkali (NaOH) to form stearate soap. Then the GB extract will be added to the final form. The formulated cream will be characterized for identifying the type of emulsion, calibration curve for GB, drug content, irritation to skin, homogeneity test, pH, FT-IR test, ex vivo studies, physical stability, and human application. Finally, a 9-questions questionnaire was published using Google forms for the human volunteers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Formulation and Evaluation of Topical Preparation Containing Pomegranate and Ginkgo Biloba for Anti-aging Activities
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Cream base
A group of volunteers receiving placebo medications without natural extracts of ginkgo biloba and Pomegranate.
Drug: Cream Base
The formulated dosage form without ginkgo biloba or pomegranate will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Typically, will be applied on two groups, one man (Group 0a) and one woman were (Group 0b) which they will be used plain cream.
Other Name: Aging group recieving placebo dosage form

Active Comparator: Pomegrante and Ginkgo biloba group
A group of volunteers with the aging state receiving natural extracts of ginkgo biloba and Pomegranate in different topical dosage forms.
Drug: Pomegrante and Ginkgo biloba group
The extracts of ginkgo biloba and Pomegranate as formulated in topical dosage form will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Formulated cream will be applied on two groups, one man (Group Ia)and one woman (Group Ib).
Other Name: Aging group receive ginkgo biloba and Pomegranate




Primary Outcome Measures :
  1. Measurement of ant-aging activity of Pomegranate and Ginkgo biloba [ Time Frame: Three months ]
    The crow's feet wrinkle of 17 volunteers will be measured compared to the control group. The significant results will measure the decrease in the depths of deep furrows for groups treated with Pomegranate and Ginkgo biloba over a three months period.


Secondary Outcome Measures :
  1. Stable topical anti-aging products for long life shelf storage [ Time Frame: Six months ]
    Stability test will be studied for dosage forms. The test will be carried out by standing the products on shelf life for six months. The stability test will be recorded using high-performance liquid chromatography each thee days.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of aging shape
  • Follow up and collect data for a local and systemic activity of Ginkgo Biloba and Pomegranate
  • The skin should be not injured as the cream can be easily applied
  • Systemic oral capsule Ginkgo Biloba and Pomegranate can be also given to enhance the activity as anti-aging activity

Exclusion Criteria:

  • Insulin-dependent diabetes
  • Hypertension disease
  • Skin wound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772418


Contacts
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Contact: Ahmed AH Abdellatif, Ph.D. +966507726856 ext 2014 a.abdellatif@qu.edu.sa

Locations
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Egypt
Assiut Clinic Recruiting
Assiut, Egypt, 71526
Contact: Ahmed AH Abdellatif, PhD         
Saudi Arabia
Faculty of Pharmacy Recruiting
Buraidah, Qassim, Saudi Arabia, 51452
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Pharmaceutics dept., Faculty of Pharmacy, Qassim University Recruiting
Buraidah, Qassim, Saudi Arabia, 51452
Contact: Ahmed AH Abdellatif, Ph.D.    +966507726856    a.abdellatif@qu.edu.sa   
Sponsors and Collaborators
Ahmed A. H. Abdellatif
Investigators
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Principal Investigator: Ahmed Abdellatif, Ph.D. Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA

Publications of Results:
Other Publications:
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Responsible Party: Ahmed A. H. Abdellatif, Assistant Prof. at Pharmaceutics dept., Faculty of Pharmacy, Qassim University, KSA, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03772418     History of Changes
Other Study ID Numbers: AlAzharPGB
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No