Randomised controlled clinical study to evaluate the efficacy of pama-dadru-vicharchikahar lepa (1) 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 Pama-Dadru-Vicharchikaha lepa(1) compare to Mometasone Furoate (0.1%) in the management of vicharchika.
研究概览
简要总结
INTRODUCTION:
In Ayurveda, all skin disorders describes under the heading of ‘kushtha‘.
Which have been classified mainly into two groups-
Viz.
Mahakushtha
Kshudrakushtha[3,4]
च.नन.५/४
Vicharchika being one among kshudrakushtha. All kushthas having tridoshaj origin,[5] hence vicharchika can be explained in similar manner i.e Kapha is responsible for Kandu, Pitta is responsible for Strava and Shyava indicate the presence of Vata. Even with its Tridoshaj origion , various Acharyas have mentioned different dominances in Vicharchika i.e. Kapha, Pitta, Kapha-Vata pradhana
2
which also suggest specific symptoms complexes. The incidence rate of vicharchika is 15% to 20%[14] in India as per WHO and is seen among the people of every age group. As per the symptoms and pathogenesis, Vicharchika has been directly associated with Eczema (dermatitis) in modern science, with symptoms Kandu ( itching), Pidaka (eruptions), Shyava (blackish discolouration), Bahustrava ( discharge,oozing), Raji ( marked lining due to thickening of skin lesion), Arti (pain), Ruksha (dryness).[6,7,8,9]
3
Eczema is broad term used for many types of skin inflammations, usually first symptom of eczema is intense itching, the rash appears later and is red in nature has a eruptions of different sizes ,for this reason ,Eczema is also called as “itch that rashes.
OBJECTIVE:
PRIMARY OBJECTIVE:
To study the therapeutic effect of Pama-Dadru-Vicharchikaha lepa(1) compare to Mometasone Furoate (0.1%) in the management of vicharchika.
- To study the disease Vicharchika and Eczema .
SECONDARY:
- To see the effect of Pama-Dadru-Vicharchikahar lepa (1) in signs and symptoms of vicharchika i.e 1)Kandu
2)Shyava varna
3)Pidika
4)Bahu strava
5)Ruja
6)Rajyo
7)Rukshata
-
Lohit varna
-
To see the effect of Mometasone Furoate 0.1% ointment in Vicharchika .
12
-
To compare the effect of Pama-Dadru-Vicharchikhar lepa (1) with Mometasone Furoate 0.1% ointment in the management of Vicharchika.
-
Pathological measurable criteria is not applicable.
-
Affected area of the patients body will be measure.
METHODOLOGY:
Type of Study Design: Randomized controlled study, Single Blind, Double Arm, INTERVENTIONAL, comparative STUDY.
SAMPLE SIZE : 60 patients (30 in each group)
GROUPING AND DRUG DELIVERY REGIMEN:
Group A : Pama-Dadru-Vicharchikahar lepa (1) Local application for twice a day for 6 weeks
Group B: Mometasone Furoate 0.1% ointment Topical application for twice a day for 6 weeks
Age group: 17 - 70 yrs
Followup : 45 days
研究设计
- 研究类型
- Interventional
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.
- •Patient having controlled thyroid 8) Patient having controlled HTN.
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 17 7.6 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.
- •Psoriasis, Pulmonary tuberculosis.
结局指标
主要结局
To study the therapeutic effect of Pama-Dadru-Vicharchikaha lepa(1) compare to Mometasone Furoate (0.1%) in the management of vicharchika.
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 Pama-Dadru-Vicharchikahar lepa (1) in signs and symptoms of vicharchika i.e 1)Kandu)