A single blind randomised controlled clinical study to evaluate the combined efficacy of Dvitiya edagajadi lepa and Aragvadhadi kashaya over Prathama edagajadi lepa and Aragvadhadi kashaya in Dadru kushta with special reference to Tinea Corporis
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
- 1.Changes in signs and symptoms of Dadru kushta such as reduction in size and color of lesion and other symptoms like kandu, pidaka and udgatam mandala etc
研究概览
简要总结
A healthy skin reflects the health of an individual. Skin is considered as one of the most important part of the body. It acts as primary defence system and also known as largest organ of the human body it is the first organ of the body interacting with environmental stimuli and natural ability of body.
Dadru kusta is Raktavaha sroto vyadhi having symptoms of iching skin, rashes etc.In Contemporary medicine Dadru kushta is correlated to fungal infection that is Tinea.
In modern medical science management of Tinea infection is carried out with usage of topical therapy alone, systemic therapy indicated for patients of Tinea are unresponsive In modern the long term usage of antifungal drugs like Azole group of drugs such as ketoconazole or Itraconazole is known to cause anaphylaxis by excreting toxins and drugs into the intestine .So prolonged intake of these antifungal drugs will leads to side effects like liver damage and altered estrogen level .Many antifungal medicines can cause severe allergic reactions such as blisters and peeling of skin or may leads to skin related diseases .Resistance can also develop over the time when fungi are exposed to antifungal drugs .The Ayurvedic formulation of bahirparimargana in the form of lepa and shamana aushadi should be taken which can acts as sthanika chikitsa externally and internally, do rakta shuddi so that disease will be cured from root.The Ayurvedic formulations having the property to completely cure this dadru kushta and the chances of reoccurrence are also very less.There are numerous yogas in the form of lepa in Ayurveda for the treatment of Dadru Kushta.
· The drugs selected under this study were Dvitiya edagajadi lepa for external application and Aragvadhadi kashaya nternally from Chakradatta and prathama Edagajadi lepa for external application and Aragvadhadi kashaya for internally from Chakradatta The drug Aragvadadha having the property of kushtaghna ,kapha pitta shamana and helps in subsiding the Dadru kushta as a shamana aushadi .
· The whole drugs of Dvitiya Edagajadi lepa having katu tiktha kashaya rasas,laghu, ruksha, tikshna gunas and having the properties of tridoshagna, kushtaghna, kandughna, krimighna, tvachya, rasayana also having shodana properties and easily available and method of preparation and administration is also easy to approach for the patient.Thus by keeping above aims this clinical trial has been selected
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects having the signs and symptoms like Viz Kandu, Raaga,Pidaka and Udgatam mandala.
- •2.Age group between 18- 65 of either sex 3.Subjects willing participate and complete with all study prescribed for prescribed trial period 4.Subjects willing to give a written consent 5.Subjects not using any topical and oral treatment for Dadru Kushta for 2 weeks prior to enrollment to study.
排除标准
- •1.Any medical condition, laboratory finding or physical examination findings like vital signs outside of specific range 2.If patient is on any concomitant medication like oral contraceptive, Thyroid medication etc 3.Patients with history of systemic illness like Diabetic mellitus, Hypertension, Endocrine disorder,Cardiac pathology, Cancer, Immune system disorder like AIDS.
- •4.Any known allergic reaction to component of study products 5.History of drug or alcohol abuse.
- •6.Pregnant and lactating women 7.Patient who have taken topical or oral steroids within one month prior to enrollment 8.Patient under treatment of another Dermatological condition.
结局指标
主要结局
1.Changes in signs and symptoms of Dadru kushta such as reduction in size and color of lesion and other symptoms like kandu, pidaka and udgatam mandala etc
时间窗: 45 days
2.Improvement in the scale
时间窗: 45 days
次要结局
- 1.Absence of scars from healed lesion(2.No occurrence of the same)
研究者
Dr Sangeetha G M
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103