Effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation-A Standard Control Open Labelled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation
研究概览
简要总结
| Title |
Effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation-A Standard Control Open Labelled Clinical Study.
|PG Scholar
Dr. Chetali Kothari
|Guide
Dr. Mrudul Chitrakar
|Study site
D.Y. Patil Deemed to be University, School of Ayurveda,
Nerul, Navi Mumbai-400706.
|Study Design
Open labelled, standard control, randomised, prospective clinical study.
|Study duration
30 days
|Aim
To study the effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation.
|Objectives
- To observe the difference in glow of facial skin.
- To observe the effect on the complexion of overall facial skin.
- To introduce a natural novel procedure in Ayurveda cosmetology.
- To assess the Quality of life.
|Population to be studied
Healthy individual with pigmented skin will be screened from Swasthya rakshan OPD and CAMPS conducted by D.Y Patil University School of Ayurveda, Nerul, Navi Mumbai.
|Sample size
GROUP A -36 participants (considering 20% dropout rate)
GROUP B -12 participants (considering 20% dropout rate)
|Inclusion criteria
- Only Female individuals
- Aged 18 years - 40 years
- Healthy individuals having pigmented skin due to sun exposure or post inflammatory pigmentation.
- Participants willing to give written informed consent.
- Participants willing to follow up.
|Exclusion criteria
- Participants not willing to participate in study
- Participants with highly sensitive skin
- Participants suffering from Active Acne, vitiligo, dermatitis.
- Participants suffering from hyperpigmentation due to genetic or hormonal factors and melasma.
|Efficacy parameters
- Photographing
- Fitzpatrick scale
- Monk skin tone scale
- Dermatoscope
- Skin detector
|Safety parameters
Adverse events recording
|Efficacy & Safety parameters Assessment Schedule
- Photographing -V1, V2, V3, V4, V5
- Fitzpatrick scale-V1, V2, V3, V4, V5
- Monk skin tone scale-V1, V2, V3, V4, V5
- Dermatoscope-V1, V2, V3, V4, V5
- Skin detector- V1, V2, V3, V4, V5
6. Physical examination: will be done on V1, V2, V3, V4, V5
7. Quality of Life Questionnaire V1 and V5
8. Questionnaire after completion of treatment-V5
|Statistical Analysis
Inter-Group Comparison: Mann-Whitney U test (for non-parametric data), Unpaired t test (parametric data)
| S.NO. |
GROUPS
GROUP A
GROUP B
|1.
PROCEDURE
Yashtimadhu Sneha Abhyanga +modified Shastika Shali Pinda Sweda
Kumkumadi Taila
|2.
ROUTE
Topical
Topical
|3.
DURATION
30 days
30 days
|4.
NO. OF PARTICIPANTS
36
12
|5.
VISITS
1-7th day daily
1st day
|6.
FOLLOW UP
7th day,
14th day,
21st day,
30th day,
7th day,
14th day,
21st day,
30th day,
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Only Female individuals 2.Aged 18 years.
- •40 years 3.Healthy individuals having pigmented skin due to sun exposure or post inflammatory pigmentation. 4.Participants willing to give written informed consent. 5.Participants willing to follow up.
排除标准
- •1.Participants not willing to participate in study 2.Participants with highly sensitive skin 3.Participants suffering from Active Acne, vitiligo, dermatitis.
- •4.Participants suffering from hyperpigmentation due to genetic or hormonal factors and melasma.
结局指标
主要结局
To study the effect of Yashtimadhu Sneha with Modified Shastika Shali Pinda Sweda on facial skin pigmentation
时间窗: 1 month
次要结局
- 1.To observe the difference in glow of facial skin.(2.To observe the effect on the complexion of overall facial skin)
研究者
Chetali Kothari
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda.