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临床试验/CTRI/2025/02/080414
CTRI/2025/02/080414尚未招募2/3 期

Efficacy of Roghan Amla Khas versus Roghan Hina with Shoneez and Mom In Androgenic Alopecia (Sala) – A Randomized Single-Blind Comparative Clinical Trial

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
34
试验地点
1
主要终点
• Change in Trichoscopy Features (Hair shaft thickness heterogeneity, peripilar sign, follicular unit with single hair and yellow dots)

研究概览

简要总结

Objectives of the study:

To evaluate the comparative efficacy of Roghan Amla KhasversusRoghan HinawithShoneez andMom in Androgenic alopecia (Sala).

Study design: A Randomized Single Blind Comparative Clinical Trial

Interventions:

Topical drug in Group 1:Roghan Amla Khas

Topical drug in Group 2:Roghan Hina with  Shoneez and Mom

Main Outcome Measures:

Primary endpoints

•       Change in Trichoscopy Features (Hair shaft thickness heterogeneity, peripilar sign,  follicular unit with single hair and yellow dots)

Secondary Endpoint

•       Decrement in score of Patient Self Assessment Questionnaire

•       Investigator Assessment Using Photography

•       Decrement In score of Hair Specific Skindex-29

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • 1.Known Cases Of Androgenic Alopecia In Male Subject With Age 20-50 Years 2.Subjects With Grade I to IV AGA According To The Modified Norwood-Hamilton Scale.

排除标准

  • 1.Subjects having diseases like scalp psoriasis, tinea capitis, Lichen Planopilaris, Trichotillomania, scarring alopecia, and alopecia areata 2.Subjects with history of CAM (complementary and alternative medicine) therapy or anti-androgenic medications or drugs causing hypertrichosis (phenytoin, acetazolamide, cyclosporine, diazoxide, psoralens, penicillamine, streptomycin and cortisone) or hypotrichosis (anti-coagulants, retinoids, lithium and beta blockers), use of finasteride or other 5-a reductase inhibitors or topical minoxidil within 01 month prior to enrolment 3.Subject with History of hair transplantation.

结局指标

主要结局

• Change in Trichoscopy Features (Hair shaft thickness heterogeneity, peripilar sign, follicular unit with single hair and yellow dots)

时间窗: 0th Day,15th Day,30th Day, 45th Day,60th Day

次要结局

  • •Decrement in score of Patient Self Assessment Questionnaire(•Investigator Assessment Using Photography)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shaikh Zoya Rashid Ahmed

National Institute Of Unani Medicine

研究点 (1)

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