Randomized controlled clinical study to evaluate the efficacy of Bakuchikadyam Choorna orally and Manashiladi tailam topically in the management of Vicharchika(Eczema)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the therapeutic effect of oral administration of Bakuchikadyam Choorna and topical application of Manashiladi tailam.
研究概览
简要总结
Introduction
Skin is the largest and important organ and outermost covering of the body which acts as a protective barrier.But very often, it is exposed to many entities which can damage it and cause many of the skin disorder. About 10-20% of the general practice includes the patients suffering from skin disorder and Eczema accounts for a very large proportion of all the skin diseases
In Ayurveda, The word Kushta is broad term, which covers almost all skin disorders.
“kushnatee iti kushthamâ€
(Ma.Ni./Kushta./Tika 1)
According to Astang hrudaya,in kushta due to vitiated dosha the part of skin becomes affected and changes its normal colour called kushtha.
Which have been classified mainly into two groups-
Viz.
(1) Mahakushtha (2) Kshudrakushtha
Vicharchika being one among kshudrakushtha,is also a Rasa,Rakta and Mansa dhatu pradoshaj vikara
According to charak samhita,vicharchika is kaphapradhan vyadhi.[6] and symptoms of vicharchika are kandu(Itching), shyava varna(blackish discolouration), pidika(eruption), bahustrava(discharge), ruja (pain), rajyo (marked lining due to thickness of lesion ), rukshata(dryness),lohit varna(redness of lesion).[5,6,10]
Also Many Acharya defined as various dosha responsible for Vicharchika vyadhi and defined vicharchika is kaphapradhan, pittapradhan, Kaphavatpradhan Disease.
purpose of study:- To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.
OBJECTIVE:
PRIMARY OBJECTIVE: To study the therapeutic effect of oral administration of Bakuchikadyam choorna and topical application of Manashiladi tailam.
SECONDARY OBJECTIVE: 1) To study the disease Vicharchika and Eczema .
2)To see the effect of Bakuchikadyam choorna and Manashiladi tailam in signs and symptoms of vicharchika i.e
1)Kandu
2)Shyava varna
3)Pidika
4)Bahu strava
5)Ruja
6)Rajyo
7)Rukshata
8)Lohit varna
3) To compare the effect of Bakuchikadyam choorna and Manashiladi tailam with Aarogyavardhini gutika and Karanjadi tailam in the management of Vicharchika.
Point for RCT :-
- Randomized proposed
Simple randomized control trial
- Allocation concealment proposed:-
Patient will be randomly allocated in intervention group with the help of Lottory method.
3)Blinding proposed :- Not applicable .
Sample size :- 60 patients
30 patients in each group
-
30 patients in intervention group.(Group –A)
-
30 patients in controlled group.(Group – B)
GROUPING AND DRUG DELIVERY REGIMEN:
Group-A (Trial group)- Bakuchikadyam choorna 3gm orally twice a day and Manashiladi tailam local application twice a day for 45 days
Group-B (Control group)- Aarogyavardhini gutika 250mg orally twice a day and Karanjadi tailam local application twice a day for 45 days
Time for drug administration :- 45 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group above 16 and below 70 years.
- •patient having classical signs and symptoms of vicharchika, a) Kandu (itching) b) Pidika (eruption) c) Syava varna (blackish discolouration) d) Strava (discharge) e) Ruja (pain) f) Rajyo (marked lining due to thickness of lesion) g) Rukshata(dryness) h) lohit varna (redness of lesion ) 3) Patient willing for clinical trial.
- •Irrespective of gender, occupation, Religion, economical barrier.
- •patients willing to participate.
- •patients who will fulfil criteria and take regular medicines with regular follow up.
排除标准
- •Age group below 16 years and above 70 years .
- •Pregnant and lactating mother.
- •Infective origins like a)Koch‘s b) Hansen‘s disease c) Scabies d) Fungal infection /herpes zoster.
- •Drug induced eczema.
- •Immune compromised like HIV,HBV 6) Systemic disorders DM,CVV 7) Diabetic wound 8) Renal diseases like CKD 9) Endocrine disorders will exclude from study to avoid over lapping of symptoms.
结局指标
主要结局
To study the therapeutic effect of oral administration of Bakuchikadyam Choorna and topical application of Manashiladi tailam.
时间窗: 7th 14th 21th 28th 35th 45th day
次要结局
- 1) To study the disease Vicharchika and Eczema(2) To see the effect of)