CTRI/2022/02/040499已完成2 期
AN OPEN-LABEL, RANDOMIZED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ANAGEN GROW AND ANAGEN GROW IN BOOSTING THE CLINICAL EFFICACY OF MINOXIDIL THERAPY IN SUBJECTS WITH HAIR FALL OF FOLLOWING TYPES: GRADUAL & CONSPICUOUS, DIFFUSED AND FRONTAL THINNING
Dr JRKs Research and Pharmaceuticals Pvt Ltd0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 male or female subjects
- •2.Subjects in the age group 22-40 years (both the ages inclusive).
- •3.Subjects willing to give written informed consent and agree to come for regular follow up visits.
- •4.Subjects willing to maintain the same hairstyle by abstaining from coloring, experimenting with newer shampoos and other types of hair care products during the study period.
- •5.Subjects willing to refrain from perming and straightening during the study period.
- •6.Subjects who are willing to avoid usage of oral medications for hair growth during the study period.
- •7.Subjects whose laboratory values during screening period are within normal limits or considered normal by the physician or Principal/Clinical Investigator and have no clinical significance.
- •8.Subjects who have no clinically significant abnormalities on the scalp during physical examination such as Tinea capitis, dandruff, Seborrheic dermatitis, Piedra, head louse and scabies.
- •9.Subjects with no clinical abnormalities during physical examination, which may interfere in the trial.
- •10.Female subjects with negative urine pregnancy test.
- •11.Female subjects willing to avoid conception of pregnancy during study period
排除标准
- •1.Subjects with known hypersensitivity to minoxidil and allergic skin.
- •2.Pregnant or lactating females.
- •3.Subjects with history of hypotension (blood pressure less than 90/60 mmHg).
- •4.Subjects with untreated or uncontrolled hypertension.
- •5.Subjects with chronic dermatological conditions of the scalp (e.g., eczema, psoriasis, infection etc).
- •6.Subjects with inflammatory scalp conditions such as lichen planopilaris.
- •7.Subjects with current or prior use of oral hair regrowth medications (finasteride, other 5 alpha reductase inhibitors) within one year or the use of nutraceutical/botanical for the above purpose in last three months before enrolment.
- •8.Subjects with application of a topical minoxidil preparation, or any other topical over the counter or prescription medication for hair regrowth to the scalp for two weeks or more during the six months before enrolment.
- •9.Subjects using medications known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics.
- •10.Subjects with concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, cytostatics, etc,)
- •11.Subjects with prior hair transplant or hair weaves.
- •12.Subjects with serious androgenic alopecia.
- •13.Subjects with folliculitis.
- •14.Subjects with presence or history of cancer including skin cancer.
- •15.Subjects with presence or history of an immunocompromised disease.
- •16.Subjects known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
- •17.Subjects with history of severe cardiac, pulmonary, hepatic, renal, endocrine, neurologic disease or mental illness.
- •18.Subjects with any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation.
- •19.Subjects who have participated in a clinical study in the past 30 days or current participation in another clinical study.
研究者
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