CTRI/2023/10/058545
Active, not recruiting
未知
A randomized, double blind, two arm, comparative, parallel, in-use tolerability, safety and efficacy study of Hair Growth and Anti-Gray Hair Oil in healthy adult females with partially gray hairs and hair fall complaints. - NI
Keva – S H Kelkar and Company Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Keva – S H Kelkar and Company Limited
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age: 20 to 55 years (both inclusive) at the time of consent.
- •2\) Sex: Healthy non\-pregnant/non\-lactating females.
- •3\) Females of childbearing potential must have a self\-reported negative pregnancy test.
- •4\) Subject are generally in good health.
- •5\) Subject with partially gray hair.
- •6\) Subject with low hair growth and complaint of hair fall.
- •7\) Subject with self\-assessed complaint of thinning of hair.
- •8\) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •9\) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non\-childbearing potential if they are surgically sterile, have been post\-menopausal for at least 1 year or have had a tubal ligation.
- •10\) If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
Exclusion Criteria
- •1\) Subjects with any other hair colour except gray.
- •2\) History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3\) History of prior use of hair growth treatment within 3 months.
- •4\) History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5\) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •6\) History of alcohol or drug addiction.
- •7\) Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8\) Subjects who have plans of shaving scalp hair during the study.
- •9\) Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10\) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
A clinical study to assess the safety and effectiveness of two different anti-stretchmark creams in healthy human subjects with complaints of stretchmarks from weight loss or post-pregnancy.CTRI/2023/09/057526Anveya Living Private Limited
Completed
Phase 3
A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / GlaucomaHealth Condition 1: null- Ocular Hypertension/GlaucomaHealth Condition 2: H408- Other glaucomaCTRI/2018/04/013091Ajanta Pharma Ltd217
Completed
Phase 3
A study of Netarsudil Ophthalmic Solution 0.02% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure in patient with open angle glaucoma or ocular hypertension.Health Condition 1: H401- Open-angle glaucomaCTRI/2020/01/022619Ajanta Pharma Ltd197
Completed
Phase 3
A Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets Vs. Methotrexate Tablets for the treatment of Active Rheumatoid Arthritis.Health Condition 1: null- Active Rheumatoid ArthritisHealth Condition 2: E888- Other specified metabolic disordersCTRI/2017/07/009079Ajanta Pharma Ltd244
Completed
Phase 2
Comparative Study to assess efficacy and safety of Mycobacterium W. in Combination with Standard Therapy versus Standard Therapy Alone in treatment of Sepsis.Health Condition 1: null- Sepsis due to Gram Negative InfectionHealth Condition 2: A419- Sepsis, unspecified organismCTRI/2015/07/005961Cadila Pharmaceuticals Limited202