CTRI/2022/02/040209已完成未知
A Safety and Efficacy study of an Ayurvedic Hair Oil in Management of Hair Fall (Khalitya) Control in Healthy Adult Human Subjects with Hair Fall (Khalitya).
Vedistry Private Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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)Ã? Age: 18 to 45 years (both inclusive) at the time of consent.
- •2)Ã? Sex:Ã? Healthy males and non-pregnant/non-lactating females.
- •3)Ã? Females of childbearing potential must have a self-reported negative pregnancy test.
- •4)Ã? Subjects are generally in good health.
- •5)Ã? Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before treatment.
- •6)Ã? Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with itching and flaking at the screening visit.
- •7) Subjects have unwashed and untreated scalp for 5 days.
- •8)Ã? All hair colors except grey hair.
- •9)Ã? Ã? Subject has hair length long enough to pluck the hairs.
- •10)Ã? The subject who does head massage.
- •11)Ã? Subjects with self-proclaimed nonpathological thinning of hair. Ã?Â
- •12)Ã? Subjects willing to give written informed consent and willing to follow study procedure.
- •13)Ã? Subjects who have used other marketed products for hair fall control in past.
- •14)Ã? Willing to refrain from any other treatment for the main indications for which the study test product is being given during the study.
- •15)Ã? Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, hair products other than the test product for the entire duration of the study.
- •16)Ã? Willing to use test products throughout the study period.
排除标准
- •1)Ã? Subjects with a history of severe hair fall due to any clinically significant problems/s like anemia, thyroid problems, etc.
- •2)Ã? History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3)Ã? History of prior use of scalp hair growth treatment within 3 months.
- •4)Ã? History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5)Ã? 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)Ã? History of alcohol or drug addiction.
- •7)Ã? Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8)Ã? Subjects who have plans of shaving of scalp hair during the study.
- •9)Ã? Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10)Ã? History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •11)Ã? Subjects having a history or present condition of an allergic response to any cosmetic products.
- •12)Ã? Any other condition which could warrant exclusion from the study, as per the dermatologistââ?¬•s/investigatorââ?¬•s discretion.
- •13)Ã? Pregnant or breastfeeding or planning to become pregnant during the study period.
- •14)Ã? History of chronic illness which may influence the cutaneous state.
- •15) Subjects participating in other similar cosmetics, device or therapeutic trials or hair / scalp care products within the last four weeks
研究者
相似试验
招募中
3 期
Efficacy of Ayurvedic hair oil formulations in self perceived hair thinning and hair loss.CTRI/2023/01/048717BVG life Sciences Limited
尚未招募
2 期
A clinical trial to study the effect of Kutajavaleha in Grahani RogaCTRI/2019/01/017277Central Council for Research in Ayurvedic Sciences New Delhi
已完成
2 期
Clinical trial of CIM-Meg19 in COVID-19 patientsCTRI/2021/05/033543Ms Meghdoot Gramodyog Sewa Sansthan80
已完成
3 期
Role of Chyawanprash in the prevention of COVID-19 in health care workersCTRI/2020/05/025275CCRAS New Delhi199
招募中
不适用
Evaluation of Hair Care Serum for Hair Fall Control and Hair Growth PotentialCTRI/2022/09/045612Vaishnavi Microbial Private Limited