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临床试验/CTRI/2024/07/071671
CTRI/2024/07/071671已完成3 期

Single Arm Clinical Trial to Assess the Efficacy of Manjishtadi Mukha Lepa in Youvanapidika Along with Bacterial Colonization and Sebum Scoring

Dr Manu Krishnan1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
To assess the efficacy of manjishtadi lepa in youvanapidika using GLOBAL ACNE GRADING SCALE

研究概览

简要总结

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinisation, inflammation, and bacterial colonisation of hair follicles on the face, neck, chest, and back by Propionibacterium acne**.** It is estimated to affect 9·4% of the global population, making it the eighth most prevalent disease worldwide.

In Ayurveda, Acne is corelated to Yauvanapidika which is caused by Kapha, Vata, and Rakta vitiation. Sharangadhara has mentioned Vaktre Snigdhata (unctuousness on face) and Pidika (boil) on face as mala**.** Manjishtadi thaila is explained in chakradutta in kshudra roga and explained as neelikapidakavyanga abhyangat eva nashayeth.

On the skin surface, the microbial community is mostly constituted by bacteria belonging to the three main genera of Corynebacteria,Propionibacterium and Staphylococci. The colonization of the pilosebaceous follicle by P. Acnes is considered as one of the central factors driving acne by taking part in the inflammatory response of the skin. Presently various treatment modalities are adopted for acne which includes anti-inflammatory, antibiotics, and comedolytic agents. However, they are reported to be expensive and with many adverse effects. Lepa is an effective treatment in acne management. This treatment is simple, effective, safe and convenient to patients in the busy schedule of modern era.

AIMS –

• To assess the efficacy of manjishtadi mukha lepa in the management of youvanapidika along with alterations in bacterial colonization and sebum production.

OBJECTIVES-

• To assess the efficacy of manjishtadi mukha lepa in youvana pidika

• To identify the alteration of Cutibcaterium acne colonization and sebum production in youvanapidika after administration of lepa

METHODOLOGY This is a single group pre and post-test clinical study to do the clinical evaluation of a serum. Prepared by convertion of lepa with Vata, Lodra and Manjishta. The sample size is 35 with study duration of 18 months,treatment duration of 30 days. Patients, who are fulfilling the inclusion criteria will be selected from the OPD of Amrita School of Ayurveda. They will be provided of manjishtadi lepa for external application on face for 14 days.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between the age group of 18-30 years, irrespective of gender 2.Patient assessed with GAGS scoring mild to moderate.

排除标准

  • 1.Acne caused due to an underlying systemic disorders, drug induced acne and seborrheic dermatitis 2.Acne cosemtica 3.Rosacea.

结局指标

主要结局

To assess the efficacy of manjishtadi lepa in youvanapidika using GLOBAL ACNE GRADING SCALE

时间窗: 14th day

次要结局

  • To identify the alteration of Cutibacterium acne colonization using bacterial culture method and sebum production using DERMALAB COMBO in youvanapidika after administration of manjistadi lepa

研究者

发起方
Dr Manu Krishnan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Manu Krishnan

Amrita school of ayurveda

研究点 (1)

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