CTRI/2023/04/052032已完成Unknown
A double-blinded, placebo-controlled, randomized, moncentric clinical study to assess the efficacyof topical ar-Turmerone on female subjects with hirsutism over a period of 14 weeks.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 33
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. Subjects who are suffering from PCOD/PCOS.
- •2. Subjects
- •willing to participate in the trial.
- •3. Subjects must be able to
- •understand English or Kannada and provide an informed consent to
- •participate in the trial also allow a photography release and agree to
- •present themselves at the Study Center for regular follow-up.
- •Subjects with a concern of visible facial hair (Hirsutism) with average score of more than 1 on Chin and Upper Lip area on the Modified
- •Ferriman-Gallwey Scoring.
- •5. Subjects agreeing to use the
- •provided investigational product provided during the study.
- •Subjects informed about the study objectives and procedures, and
- •able to understand them.
- •7. Subjects willing and able to fulfill
- •the study requirements and schedule.
- •8. Subjects willing to
- •avoid oily, greasy, junk food and high-sugar food items, as much as
- •possible during the study period.
- •9. Female of childbearing
- •potential, who is not sexually active, or who is using an effective
- •contraceptive method for at least one month before the beginning of
- •the study, and throughout the study
- •a. (The effective
- •contraceptive methods: sexually active females of childbearing
- •potential should either be surgically sterile (oophorectomy,
- •hysterectomy, or tubal ligation), or should use a medically accepted
- •contraceptive regimen: diaphragm or cervical cap with intravaginal
- •spermicide, intravaginal device, intrauterine device (IUD), condom
- •with spermicide.)
- •10. Subject must agree not to use any other
- •product/treatment/home remedy/soap bar on their face during the
- •study period other than the test product having a hair removal or
- •reduction effect
- •11. Subjects must not carry out bleaching or
- •any other procedures including facial etc. on the face during the
- •study period.
- •12. Subjects must agree not to expose to
- •excessive sunlight. (Sun exposure not more than half an hour daily
- •and during that time use of umbrella to cover face).
- •Subjects must agree to remove all jewelry on/around face (e.g.,
- •necklace, earrings, if possible, nose ring), during Digital imaging.
- •14. Subjects willing to give a voluntary written informed
- •consent, photography release and agree to come for regular follow
- •15. Subjects willing to abide by and comply with the study
- •16. Subjects must not have participated in a similar
- •investigation in past four weeks.
- •17. Subjects who are willing
- •not to participate in any other clinical study during participation in the
- •current study.
排除标准
- •Subjects who are pregnant or lactating or who are planning to
- •become pregnant during the study.
- •2. Sexually active female subjects of child bearing potential who are
- •on oral contraceptive pills
- •3. Those who received drugs known to cause hirsutism or interfere
- •with hormonal studies.
- •4. Women with Cushing syndrome and CAH as per the medical
- •examination and blood test report.
- •5. Subjects having severe illness like hypertension, ovarian cancer or
- •any other form of malignancy, thyroid dysfunction.
- •6. Women who are having hypertrichosis.
- •7. Women who are taking following medications: androgens,
- •glucocorticosteroids, progestins, acetazolamide, latanoprost,
- •streptomycin, psoralen, estrogen antagonists (clomiphene,
- •tamoxifen), minoxidil, cyclosporine, danazol, diazoxide, phenytoin,
- •D-penicillamine, and interferon.
- •8. Subject who is under the treatment/care of a dermatologist/
- •gynecologist.
- •9. History of allergies, hypersensitivity or any serious reactions to
- •any cosmetic products.
- •10. Any significant skin pathology in the test areas, like rosacea, or
- •11. Any significant medical condition that would interfere with the
- •participation in the study, as per the opinion of the Investigator.
- •12. Any concomitant medical/surgical condition or using medication which may harm the subject or interfere with the study assessments, as per opinion of the Investigator.
- •13. Any dermatological procedure on the test areas (laser peel,
- •dermabrasion etc.) taken 4 weeks before the start of the study and
- •during the study.
- •14. Having participated in the last 30 days before screening or
- •currently participating in another clinical study.
- •15. Unable to be contacted by phone in case of emergency.
研究者
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