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临床试验/CTRI/2024/12/078013
CTRI/2024/12/078013尚未招募2/3 期

To evaluate the efficacy of Jatiphala Lepa on Vyanga w.s.r to Melasma-An experimental pilot study

Sushritha Ayurvedic Medical College and Hospital Pharmacy1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
The effect of Jatiphala Lepa on Vyanga wsr to Melasma will be assessed using MASI score.

研究概览

简要总结

Title**:** To evaluate the efficacy of Jatiphala Lepa on Vyanga w.s.r to Melasma-An experimental pilot study.

 Introduction :

According to Ayurveda broadly the skin manifestations are explained under the heading of Kushta.But there are certain clinical conditions diagnosed based on the presentation over the skin only.One among them is Vyanga which have been incorporated under Kshudra Roga according to Acharya Sushruta.1

The Lakshanas of Vyanga explained are Nirujam (painless*), Tanukam* (not elevated from the skin surface*), shyaavam*(blackish colour) according to Yogaratnakara and Acharya Sushrutha 2,3.

 According to modern medicine it can be compared to Melasma. It is an acquired condition of symmetrical hyperpigmentation, mostly seen on the face. Though the exact etiology is unknown, multiple causes including sunlight exposure, hormonal changes, and family history has been proven. The incidence and prevalence of melasma is higher in females with a female to male ratio of approximately 4:1.

Melasma predominantly occurs in three major facial patterns. Centrofacial which includes forehead, nose, upper lip excluding the philtrum, cheeks, and chin where as Malar includes malar cheeks of face and Mandibular include jawline and chin.

A newer pattern has also been seen which is extra facial and occur on non facial body parts like neck, sternum,forearms, and upper extremities.

Treatment includes topical applications using corticosteroids,laser treatment and many more.These are aimed at various aspects of the pathogenesis of melasma including photodamage, inflammation,vascularity and pigmentation. But there are limitations in this treatment as it may damage healthy cells and also reoccurrence is observed. 5

In Ayurveda, Chikitsa for Vyanga includes Lepa i.e external application using different herbs and purificatory therapy .According to Yogaratnakara,among many lepas, Jatiphala Lepa has been specifically explained.3

 Need for the study-

A research study on melasma is essential as it is affecting millions worldwide, causing emotional distress and impacting quality of life .With current treatments often have limited efficacy, significant side effects and high recurrence rates,hence study has been taken up with Jatiphala Lepa as it is cost effective and easily available.

 Objective: To evaluate the efficacy of the Jatiphala Lepa in the management of Vyanga w.s.r to melasma.

 Materials and Methods-

 Source of data-

Minimum of 10 patients diagnosed with Vyanga fulfilling the study criteria will be randomly selected from OPD and IPD of Sushrutha Ayurvedic Medical College and Hospital,Bengaluru.

 Drug source-

Jatiphala and Go Ksheera

Jatiphala will be procured and powdered from the Sushruta Ayurveda Pharmacy.

Go Ksheera will be freshly collected from  the Goshaala.4

 Methodology-

The freshly prepared Jatiphala Lepa will be applied over the affected area every day for 28 days.Once the Lepa dries, will be washed with cold water.

A semisolid paste is prepared with Jatiphala choorna and quantity sufficient freshly collected Go Ksheera.

 Diagnostic criteria-

Macular skin lesion with blackish discoloration over the face

 Inclusion criteria:

1.      Pigmentation caused by over exposure to sunlight

2.      Due to hormonal changes, as an after effect of pregnancy and menopause

3.      Having a positive family history

 Exclusion criteria:

1.      Pigmentation seen due to burns

2.      Medication allergy

 Assessment criteria:-

MASI score

MASI score( Melasma Area and Severity Index) is a scale used to measure the extent of facial hyperpigmentation. It is a numeric score calculated as an area weighted score of pigmentation located on forehead, chin, and both malar cheeks.5

 Table showing the grading of the melasma area and severity index

Area(A)

0=No involvement;

1=<10% involvement;

2=11-29% involvement;

3=30-49% involvement;

4=50-69% involvement;

5=70-89% involvement;

6=90-100% involvement.

|Darkness(D)

0=normal skin color;

1=barely visible hyperpigmentation;

2=mild hyperpigmentation;

3=moderate hyperpigmentation;

4=severe hyperpigmentation.

|Homogenity(H)

0=normal without evidence of hyperpigmentation;

1=specks of involvement;

2=small patchy areas of involvement <1.5 cm diameter;

3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas.

Total score range from 0 to 48

 Assesment will be done on th day(before treatment) and 29 th day   (after the treatment )

References

1.Sushruta,Sushruta samhita,Nibandha sangraha commentary by dalhana,nidhana sthana,chapter 13,verse 45-46,chaukambha orientalia,Varanasi,reprint edition ,2019  ,pg no. 324.

2.Sushruta,Sushruta samhita,Nibandha sangraha commentary by dalhana,chikitsa sthana,chapter 20,verse 33-36,chaukambha orientalia,Varanasi,reprint edition,2019 ,pg no. 480.

3.Yogaratnakara samhita,vaidyaprabha commentary by Dr.Indradev Tripathi and Dr Daya Shankar Tripathi,Kshudraroga nidana chikitsa adyaya,verse 42-43,Chowkhamba Krishnadas Academy,Varanasi,2nd edition,2007,pg no.695.

4.Yogaratnakara samhita,vaidyaprabha commentary by Dr.Indradev Tripathi and Dr Daya Shankar Tripathi,Kshudraroga chikitsa adyaya,verse 132,Chowkhamba Krishnadas Academy,Varanasi,2nd  edition,2007,pg no.703.

5.Harrison’s et.al,Harrison’s Principles of Internal Medicine,A Blackiston publication,edition,pg no. 620.

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
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Pigmentation caused by over exposure to sunlight
  • Due to hormonal changes, as an after effect of pregnancy and menopause
  • Having a positive family history
  • Aged Between 25 to 50 years.

排除标准

  • Pigmentation seen due to burns
  • Medication allergy.

结局指标

主要结局

The effect of Jatiphala Lepa on Vyanga wsr to Melasma will be assessed using MASI score.

时间窗: Assessment will be done on baseline i.e, 0th day and 29th day.

This will be helpful to see the drug effect and its imppact on patients health

时间窗: Assessment will be done on baseline i.e, 0th day and 29th day.

次要结局

  • It heps in overcoming the emotional distress and impacting quality of life(60 days)

研究者

发起方
Sushritha Ayurvedic Medical College and Hospital Pharmacy
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Pooja BA

Sushrutha Ayurvedic Medical College and Hospital Bengaluru

研究点 (1)

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