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临床试验/CTRI/2025/06/088782
CTRI/2025/06/088782尚未招募3 期

A single-arm clinical study to evaluate the efficacy of Dushivishari Agad orally and Arjuntwak churna lepa in the management of Vyanga with special reference to Melasma

Dr . Shivali Ajay Nimgale1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
MASI SCALE

研究概览

简要总结

Melasma is a hyperpigmentation disorder of skin. It causes hyperpigmented causes on cheeks, chin  upper lips, nose and forehead. Skin is the biggest organ of the body.  Now a days harmful toxins like UV radiation, environmental pollution, use of cosmetics, oral contraceptive pills etc have direct effect on skin  which leads to skin disorders . This toxins get accumulated in the body and causes skin diseases like melasma . It is also called as Chloasma. In contemporary medicine, melasma is treated with use of steroids, skin peeling, chemical peeling, PRP like procedures, which may have many side effects which are yet to be known and are quite expensive for economically poor people.  Ayurveda  treatment is safe, convenient, cheap and easy to use. This study includes use of Dushivishari Agad orally and arjuntwak churna for external application . This are herbal formulations which  includes herbs having  specific properties like anti itching, blood purifying, anti poisonous, skin brightening etc.

Contents of Dushivishari Agad

Piper nigrum ( pippali)

Cybopogon martini (Dhyamak)

Nordostachy jatamansy ( jatamansi)

Symplococus racemosa ( Shaavara)

Cyperus rotundus (Musta )

Tribulus terristris ( Suvarchika)

Pavonia odorata (Toya )

Elitaria cardamomum ( Sukshma ela)

Red ochre ( kanak gairik)

And Arjuntwak churna is the powdered form of skin of Arjun plant bark.

Dushivishari Agad will me given in tablet forms in dose of 500 mg BD and Arjun twak churna will be used as face pack for external application on the affected area for 2 months. 4 Follow ups after every 15 days will be carried out on 15th, 30th, 45th and 60th day. Grade scale which induces grading of skin color, itching, dryness, oiliness, diameter, burning sensation  along with MASI SCALE (Melasma Area and Severity Index)  will be used as a assessment parameter. Before treatment  and After treatment  will me compared and discussion will be made on observations. Conclusion will be drawn on the basis of discussion.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

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

入选标准

  • pts comimg to Sane Guruji Arogya Kendra having Sign and Symptoms of Vyanga (Melasma) will be selected irrespective of their gender , community, caste and economic status.

排除标准

  • Patient with present and past history of any skin diseases like psoriais, eczema.
  • Pregnant and lactating women .
  • Patients having Hyperpigmentation due to Addisons Diseases, cushings Diseases.
  • Already Diagnosed Thyroid Diseases.

结局指标

主要结局

MASI SCALE

时间窗: baseline 15th day 30th day 45th day and 60th day

GRADE SCALE

时间窗: baseline 15th day 30th day 45th day and 60th day

To evaluate the efficacy of Dushivishari Agad orally and Arjun Twak churna lep in the management of Vyanga with special reference to melasma

时间窗: baseline 15th day 30th day 45th day and 60th day

次要结局

  • To observe adverse effect of Dushivishari Agad and Arjunchurna lepa(baseline 15th day 30th day 45th day 60th day)

研究者

发起方
Dr . Shivali Ajay Nimgale
申办方类型
Other [self]

研究点 (1)

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