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临床试验/CTRI/2025/01/079618
CTRI/2025/01/079618尚未招募2 期

A Comparative Randomized Clinical Trial of Manjishtadi Taila and Manjishtadi Cream in the Management of Vyanga with Special Reference to Melasma

National Institute of Ayurveda, Deemed to be University, Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Change in severity of pigmentation measured as per the assessment criteria - size, color, number of patches, associated symptoms like itching and burning sensation, mMASI score at baseline and after treatment.

研究概览

简要总结

Hyperpigmentation disorders are one of such rationale that affects the normalcy of facial skin. Melasma is generally a clinical diagnosis consisting of symmetric reticulated hyper melanosis on face. Vyanga is one of the Kshudra roga that affect the second layer of Twak which is characterised by the presence of Niruja (painless), Tanu (light) & Shyava mandala over the face.

Manjishtadi Taila: Among the various management methods of Vyanga, abhyanga is considered to be one of the simple & effective procedure. According to Chakradatta, application of Manjishtadi Taila helps to cure vyanga in 7 days.

Manjishtadi Cream: It is a modified form of a traditionally recommended Ayurvedic formulation Manjishtadi Taila commonly used for skin disorders. In today’s lifestyle, applying the oil makes the face greasy and sticky, and massaging the oil is time consuming. Transforming the same formulation into a cream will provide a more convenient, less time consuming and user-friendly alternative as creams are non sticky and easily absorbable form.

This study is to compare the efficacy of Ayurvedic formulation, Manjishtadi Taila and modern cosmetic product, Manjishtadi Cream in the management of Vyanga.

Research Question: Whether there is any difference in clinical efficacy of Manjishtadi Taila and Manjishtadi cream in the management of Vyanga?

Study Design: The study consist of 2 groups with 15 patients in each group.

Group A: Application of Manjishtadi Taila for 2 months.

Group B: application of Manjishtadi Cream for 2 months.

Assessments: Assessment will be done on the basis of scoring pattern for symptoms of Vyanga and mMASI scoring for Melasma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting clinical features of Vyanga.
  • sudden onset of painless, circular, thin, blackish patches on face.

排除标准

  • Patients with known case of Carcinoma, Burns, Herpes, Eczema, Psoriasis, Measles, Chickenpox, Leukoderma and Leprosy.
  • Patients with known case of common systemic diseases like T.B. Diabetes, AIDS and Chickenpox.

结局指标

主要结局

Change in severity of pigmentation measured as per the assessment criteria - size, color, number of patches, associated symptoms like itching and burning sensation, mMASI score at baseline and after treatment.

时间窗: 2 months

次要结局

  • Adverse Events-Monitoring and documenting any side effects or complications arising from treatment(2 months)

研究者

发起方
National Institute of Ayurveda, Deemed to be University, Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anjana M R

National Institute of Ayurveda, Deemed to be University, Jaipur

研究点 (1)

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