A Randomised Controlled Clinical Study to evaluate efficacy of Nrupavallabha taila Marsha Nasya followed by Raktachandanadi Udvartana in the management of Vyanga With Special Reference to Melasma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1.There is reduction in MASI (Melasma Area Severity Index) Score indicating reduced Melasma.
研究概览
简要总结
Flawless skin is a subject of socio-medico importance. Attitude towards flawless skin is increasing now a days, which also boost our confidence. Among all disorders, Vyanga is a type of Kshudra roga (group of skin disorder) explained by Acharya Sushruta in Lohit Twacha.
Among Panchakarma, Nasya is one indicated in Vyanga chikitsa by acharya Charaka and there are also local application like Lepa, Abhyanga, Udvartana etc.
According to Acharya Chakradutta Nrupavallabha taila and according to Acharya Vagbhat Raktachandanadi churna has vyanga nashak effect. Proper authentication and standardization of raw material and finished product will be done.
For an active control Kanakataila marsha nasya followed by Raktachandanadi Udvartana is used. The study is divided into 2 arms -
Intervention arm - Nrupavallabha taila marsha nasya followed by Raktachandanadi Udvartana
Comparator arm - Kanakataila marsha nasya followed by Raktachandanadi Udvartana
The study is single blind (participant blinded). Randomization will be done by using computer software.
32 sample size is taken from each arm, making it 64.
The volunteers will be asked for a marsha nasya with 8-8 drop of taila for 7 days then raktachandanadi udvartana for next 14 days. Vyanga will be assessed with the help of MASI ( Melasma Area Severity Index) score and color of vyanga will be measured with the help of Fitzpatrick scale.
After 7, 14 & 36 days follow up will be taken. The MASI score and Fitzpatrick scale is calculated and changes will be noted.
Statistical analysis and appropriate conclusion will be drawn.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fit for Nasya Karma according to Classics.
- •Patients having signs and symptoms of Vyanga like mandalakara, niruja, tanu, and shyav-varni mandala on face with 0.
- •Patients having age group
- •Patients of both genders.
- •Chronicity less than 5 years.
排除标准
- •Pregnant and lactating women.
- •Post inflammatory hyperpigmentation, post acne hyperpigmentation.
- •Vyanga caused since birth like Nevus of ota.
- •Patients using depigmentation agents.
- •Patient having Acne vulgaris.
- •Patient having history of HIV /AIDS.
结局指标
主要结局
1.There is reduction in MASI (Melasma Area Severity Index) Score indicating reduced Melasma.
时间窗: Day 1 and Day 36
2.There is reduction in Fitzpatrick scale score indicating reduced Color Melasma.
时间窗: Day 1 and Day 36
次要结局
- Assessment of no.of Mandala (circular lesions), Rukshata (Dryness), Size (diameter)(Day 1 and Day 36)
研究者
DR KAJAL PRAMODRAO DAHAKE
R A Podar Medical (Ayu) College, Worli, Mumbai