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临床试验/CTRI/2025/02/080706
CTRI/2025/02/080706
进行中(未招募)
3 期

An open labelled single arm prospective clinical trial to evaluate the efficacy of raktachandanadi lepa in vyanga w.s.r. to melasma

Govt. Ayurveda College Rewa M.P.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月25日最近更新:

概览

阶段
3 期
状态
进行中(未招募)
发起方
Govt. Ayurveda College Rewa M.P.
入组人数
50
试验地点
1
主要终点
Improvement in subjective parameters like shyava, niruja and tanu mandala on mukha.

概览

简要总结

Title -

ANOPEN LABELLED SINGLE ARM PROSPECTIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTACHANDANADI LEPA IN VYANGAW.S.R. TO MELASMA

Aim -

·      To assess the efficacy of Raktachandanadi lepa in the management of Vyanga.

Objectives -

·       To elaborate the Ayurvedic etiopathology and symptomatology of Vyangaand identify its correlation with melasma.

·       To discuss the treatment principles mentioned in various Samhita for the management of the disease vyanga.

**Introduction -Vyanga has been described under kshudra roga by Acharya Sushrutaand Acharya Vagabhatta. Kshudra roga, as the name suggests, are generally not very significant diseases in terms of causing suffering to patients yet, these are difficult to get rid of.

Vyanga is caused due to anger and physical exertion which vitiatesvata and pitta doshas which in turn reflect the classical symptoms ofvyanga such as aruja(painless),tanu(thin layered), shyava(dark colored /brown), mandal(circular patches) on face.

Clinical features of melasma are similar to those ofvyanga. Melasma is most common pigmentary disorder with symmetrical brown patches and irregular edges. It is also known as chloasma or mask of pregnancy. Causes of melasma are unknown but probable factors include UV radiation, cosmetic procedures, oral contraceptive pills and hormonal disturbances.

**Need of research -**MELASMA is common pigmentary disorder in India with prevalence of 0.25-4%.There are many treatment principles in classical text to treat vyangabutlepana plays a vital role as it is applied directly on the affected part. Vyangais such a condition which affects the beauty as well as personality so, person may suffer from inferiority complex, anxiety, isolation etc. This study therefore aims to testify the result of raktachandanadi lepa in the management of vyanga on the contrary of chemical peeling, laser, microneedling. Also, this study aims to improve care coordination and communication in order to advance the diagnosis of melasma and improve outcomes.

Study Design - Study Type : Interventional

Purpose : Treatment

Masking : Open Labelled, Clinical Trial

Direction : Prospective

End point : Efficacy

No. of Groups : single Group

Sample Size : 30 Patients

Probable Mode of Action of Drug - Raktachandanadi Lepa incorporates various ingredients traditionally believed to ameliorate skin health and appearance.The blend of dravya (herbal constituents) in this formulation works synergistically to enhance skin luster and reduce dryness. This lepa is applied locally on the face, promoting improved skin texture and minimizing discoloration through its various beneficial properties, including twakdoshahara which helps in skin ailments

Raktachandana which is known for its blood-purifying properties.

Manjishtha which supports even skin tone.

Lodhra which is Raktapittanut, Kaphapittanut

Kushtha having Raktashodhak, Kushthaghna, Varnya properties

Priyangu is also Raktashodhak,Twagdoshahar

Vatankur which is Varnya, kaphapittahar

Masur having Varnykar properties to improve skin texture.

**Treatment regimen -**Drug : Raktachandanadi lepa

Form : Lepa

Treatment Duration : 21 Days

Follow up : 6 months

Thickness of lepa : According to Maharshi Sharangadhara the thickness of the Varnya Lepa should be ½ (9.75mm) Angula

Dose : Quantity required as per the area of the affected part.

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
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with the classical signs of melasma(vyanga) according to ayurveda and modern text.
  • Brown patches present only on face region.
  • Chronicity less than 3 years.
  • Patients fulfilling the diagnostic criteria.

排除标准

  • Inflammatory pigmentation, malignant melanoma, Acne Vulgaris.
  • Painful and hard lesions.
  • Patches on neck and upper chest.
  • Patients on certain medications(OCP, HTN)
  • Patients having vyanga since birth(Nevus of OTA).

结局指标

主要结局

Improvement in subjective parameters like shyava, niruja and tanu mandala on mukha.

时间窗: from 0 to 21 days

次要结局

  • To assess the effect of trial drugs in improving the signs and symptoms as per assessment criteria and MASI score.(After 21 days)

研究者

发起方
Govt. Ayurveda College Rewa M.P.
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Naini Jain

Govt. Ayurveda College Rewa

研究点 (1)

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