Prospective single arm open clinical trial to study the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in the management of Vipadika
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika
研究概览
简要总结
Single arm open clinical trial
This study is conducting to evaluate the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika .
After screening patients at OPD and IPD level 30 patients will be selected for trial , informed written consent will be taken in native language.
Vipadika is one of the kshudra kushtha.It involves predominantly vata and kapha dosha and is characterized by pani-pada sphutanam(fissure in palms and soles),severe pain (teevra vedana).since there is no satisfactory treatment for Vipadika in conventional medicine, Ayurvedic treatment can provide promising results in this condition which is effective and prevents its recurrence.
Null hypothesis
Darvi Guduchyadi Ghan Vati (500 mg) and local application of Tundi Ghrit twice a day for 21 days is not significantly effective in Vipadika.
Alternate hypothesis
Darvi Guduchyadi Ghan Vati (500mg) and local application of Tundi Ghrit twice a day for 21 days is significantly effective in Vipadika.
Drug- Darvi Guduchyadi Ghan Vati
Dose- 500 mg twice daily orally
Anupana-koshna jala
Sevan kala- vyanodan (after food)
Duration - 21 days
Follow up -11 th day and 21 st day
Drug-Tundi Ghrit
Dose- local application as necessary
Kala- two times a day
Duration -21 days
Follow up - 11th day and 21 st day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 patients having clinical signs and symptoms of Vipadika like panipadasphutanam (cracks/fissures on palms or soles),vedana (pain),kandu (itching),saraga pitika(red coloured pustules on palms and soles),twakrukshata(roughness of skin) described in Ayurvedic classics without any bar of caste,sex, religion 2 patients having chronicity of Vipadika under 5 years.
排除标准
- •1 pregnant and lactating mothers.
- •2 patients with serious illness like HIV, Malignancy, major liver disorders,end stage renal disease.
- •3 patients having bleeding disorders.
- •4 patients taking immunosuppressive therapy.
结局指标
主要结局
To evaluate the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika
时间窗: 11 th day ,21 th day
次要结局
- 1 To study the efficacy of Darvi Guduchyadi Ghan Vati and local application of Tundi Ghrit in Vipadika(2 To study the etiopathology of Vipadika)
研究者
Dr Aishwarya Pralhad Mule
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara