A Single Blind Randomised Controlled Clinical Study to evaluate the Varnya and Medhya effect of Yastimadhu ghrita over Manjishta ghrita internally and externally in Mukha Vyanga with special reference to Melasma
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in signs and symptoms of Melasma such as reduction in the size and colour of the lesion and other symptoms like roughness, itching, tingling if present, observing the safety or no side effects of the intervention undertaken.
研究概览
简要总结
Mukha vyanga is caused due to the conjugation of vata dosha, pitta dosha and rakta dosha. Acharyas explained the causes of vyanga like krodha(aggression/irritability), ayasa(Mental Stress), shoka(feeling low) etc., which are lakshanas of manasa karma atiyoga and mithyayoga. Hence it can be drawn that Manas also plays an important role in the pathology of vyanga. Vyanga is characterised as Niruja(painless), Tanuka(thin), Shyava mandals(blackish grey patches) on mukha(face). Considering the Lakshana samanyata, Vyanga, according to modern science can be correlated to Melasma. Observing these points,Yashtimadhu in the form of ghrita is considered. Yashtimadhu has Madhurarasa,Varnya, Kandughna, Shonitastapana properties along with Medhya and Rasayani gunas and Ghrita is considered to possess Vatapitta prashamaka, Varnya, Medhya strengthens brain and nervous system with deepaniya properties which may helpin the aamanagement of Vyanga lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Classical signs and symptoms of Vyanga like Shyava(brown coloured patches), tanuka(thin,non elevated), niruja(painless) mandalas on mukha, with or without kandu or daha or chimchimata associated with or without manasika hetus.
- •Subjects willing to participate and comply with all study procedures for prescribed trial period.
- •Subjects willing to give a written consent.
- •Age group between 18-55 yrs of either sex.
- •Subject not using any topical treatment for melasma for 2 weeks prior to enrolment to the study.
排除标准
- •Any medical conditions, laboratory findings or physical examination findings like vital signs, outside of specific range.
- •If subject is on any concomitant medications like oral contraceptives, thyroid medications and hormone replacement therapies.
- •Known allergic reaction to component of study product.
- •Treatment with other investigatory drug or other intervention within a specific time frame.
- •H/O drug or alcohol abuse.
- •Pregnant and lactating women.
- •Subject who have taken topical or oral steroids within 1 month prior to enrolment.
- •Subject who have taken topical tretinoin within 3 months or topical hydroquinone within 6 months prior to enrolment.
- •Subject under treatment of another dermatological condition.
- •Post Inflammatory Hyperpigmentation(PIH).
结局指标
主要结局
Changes in signs and symptoms of Melasma such as reduction in the size and colour of the lesion and other symptoms like roughness, itching, tingling if present, observing the safety or no side effects of the intervention undertaken.
时间窗: 90 days
Improvement in the Melasma Quality Of Life Scale.
时间窗: 90 days
次要结局
- Gaining Twak sara purusha lakshana(Good skin health) like unctousness, smoothness, softness, clean, delcate & lustre.(Improvement in sleep & appetite of patient.)
研究者
Dr Sapna Xavier Lope
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and PhD studies center Gadag