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临床试验/CTRI/2024/06/068637
CTRI/2024/06/068637尚未招募2 期

A randomized, double blinded, two arm, parallel group, placebo controlled clinical study toevaluate the effect of 250 mg water dispersible Turmeric extract capsules (TurmXTRA60N) on facial skin parameters and its in-use tolerance in healthy adult women participants. - NI

utriventia Limited Unit0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Healthy women participants from 18-40 years of age declared healthy after assessing
  • medical history, physical examination and clinical judgment of the investigator.
  • 2. Presence of blemish on face (Post inflammatory hyperpigmentation, acne marks, age
  • spots, sun spots) with otherwise healthy skin on the test area.
  • 3. Willingness to discontinue the use of other cosmetic products on face during the course
  • of the study.
  • 4. Accepting not to use topical or / and oral products with the same end benefit or products
  • containing sunscreen which might interfere with the study results, during the entire study
  • 5. Cooperating, informed of the need and duration of the examinations, and ready to comply
  • with protocol procedures.
  • 6. Having signed a Consent Form, after being informed orally and in writing of all
  • information concerning the study procedures and study objectives.
  • 7. Willingness to avoid intense UV exposure as far as possible for the entire study duration.
  • 8. Results of screening test are within normal range or considered not clinically significant
  • by the principal Investigator.

排除标准

  • 1. Male participants.
  • 2. Peri-menopausal and post-menopausal women.
  • 3. Pregnant women as confirmed by UPT or lactating women.
  • 4. Presence of any cutaneous conditions on test site (scars, moles, papules etc).
  • 5. Presence of any clinically significant systemic or cutaneous disease, which may interfere
  • with study treatments or procedures.
  • 6. History or presence of substance abuse (alcohol, drugs, smoking).
  • 7. Subject likely to undergo any surgery during the period of the study or within 01 month
  • of study completion.
  • 8. Participation in any other experimental Investigational study within last 1 month as
  • identified during screening on visit 1 (V1).
  • 9. Presence of any hard damage to skin (e.g., excessive sunburn or suntan).
  • 10. History of use of collagen peptide containing supplement in the past 6 months.
  • 11. History of consumption of high doses of vitamin C (>500 mg a day) or any other high
  • dose antioxidant product in the past 1 month.
  • 12. Subjects on any nutritional supplement or consuming any therapeutic medication for any
  • disorder for last 45 days.
  • 13. Subjects with known allergies to any of the ingredients of the study products
  • 14. Individuals with chronic gastrointestinal issues such as frequent indigestion, GERD.
  • 15. Subjects with severe acne.
  • 16. Subjects with the history of gallstones or bile duct obstruction disorders.
  • 17. Subjects with the history of bleeding disorders.
  • 18. Difficulty in swallowing and retaining oral formulation.
  • 19. Any history of difficulty in accessing veins to draw blood.

研究者

发起方
utriventia Limited Unit

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