An open labelled single arm prospective clinical trial to evaluate the efficacy of Arka Taila along with Navkarshika Kwatha in management of Vicharchika w.s.r. to Eczema.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in subjective parameters like itching, depigmentation, eruption, roughness, burning.
研究概览
简要总结
TITLE-AN OPEN LABELLED SINGLE ARM PROSPECTIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF ARKA TAILA ALONG WITH NAVKARSHIKA KWATHA IN MANAGEMENT OF VICHARCHIKA W.S.R. TO ECZEMA
AIM AND OBJECTIVES:
AIM: To assess the efficacy of arka oil along with navkarshika kwatha in the management of vicharchika.
OBJECTIVE
To assess the clinical efficacy of external application of Arka Taila along with oral administration of navkarshika kwatha in relieving various symptoms of Vicharchika.
To elaborate the conceptual details of Vicharchika as per Ayurvedic classics & correlate it with Eczema.
INTRODUCTION -
Kustha is a disease of skin and so to understand the total
etiopathogenesis of disease, normal structure of the skin should be
considered.Tvacha is a sthana of Sparshanendriya. Tvacha, Charma words
are used for the skin in all Ayurvedic classics.
According to Charak, the features ofVicharchika are
Kandu,Pidika,Shyvta,Vahushrava.
a skin ailment where in eruptions over the skin appear with dark pigmentation, itching and with a profuse discharge.
Skin is the largest sense organ of human body which even covers the other sense organs. It is a very sensitive part of human body. Any pathological change in the external or internal environmental factor shows great effect on skin which leads to improper functioning.
In Ayurveda, all skin diseases are explained under a single heading of Kushtha. All Kushtha occur due to aggravation of Tridoshas.
Vicharchika is a type of Kshudra Kusthaoccuring mainly due to the imbalance of Kapha doshas according to Charak*, Acharya*Sushrut mentioned it is mainly due to imbalance of pitta.
NEED OF THE STUDY:
Being skin manifestations, psychological distress can lead to significant depression and social isolation and it affects the personal, social, and economic life of a person.According to WHO, the most common skin diseases are Dermatitis (24.2%) as [chronic dermatitis (16.9%), allergic contact dermatitis (3.5%), irritant contact dermatitis (1.2%), seborrheic dermatitis (1.2%), and stasis dermatitis (1.5%)], then fungal infections (17.6%). The prevalence of contact dermatitis was 4.38% among the dermatology OPD attendees. Contact dermatitis was common in the age group of 41 to 50 years. In urban areas, femaleswere more affected than those in rural area.Steroid creams, vitamin D3 cream, PUVA and immune system suppressing medications such as methotrexate(antimetabolite) are the mainstay of treatment of eczema. These modern treatment modalities are not devoid from grave complications mainly in long term use. Owing to these reasons, there is a need for treatment having good efficacy and no toxicity Profile**.**This study will therefore, help in filling the gap by establishing the role of arkaoil along with navkarshika kwatha described in Ayurveda in management of vicharchika
STUDY DESIG:
Study Type: Interventional
Purpose: Treatment
Masking: Open Labelled, Clinical trial
Direction: Prospective
End point: Efficacy
No. of Groups: Single Group
Sample size: 40 Patients
DRUG DETAILS:
1.Navkarshik Kwatha- Triphala, Manjistha, Nimba, Vacha, Katurohini, Daruharidra , Vatsadani.
2.Arka Taila: Haridra Kalka, Shasarpa Taila, Arka Taila.
Probable Mode of Action of Drugs:
1.Navkarshik Kwatha-
katu,tikta kashaya rasa pradhana, with laghu & ruksha guna predominance and six content have ushna veerya,five contents have katu vipaka.
Katu andtikta rasa of Navkarhika kwatha katu & tikta rasaact onkapha dosha,laghu & ruksha gunas arekaphashamakahave deepana, pachana karma that helps to improve metabolism by the property of Amapachana.
Ushna veerya of Navkarshika kawtha act as stroto shodhaka and kleda shoshaka; eliminate morbid doshas accumulated in the body,addition, laghu andruksha guna act as kleda shoshaka, mala of kapha dosh.
2.Arka Taila:
Vicharchika is caused due to vitiation of Tridoshas. ThedushyasareTwak, Rakta, Mansa &*Lasika.It is caused inBahya Rogamarga.*Mode of entry for this is Bahya Rogamrga.
The three components of Arka taila are Arka patra, Haridra, andSarshapa taila.
Vishaghna and Kusthaghna are active in Arka Patra.in action Haridra is Kuthagna,Vishagan and Varnya.
In action,Sarshapa tailais kandughna and kushtagha.
Arka Taila helps to minimize discharge by Tikshna, Ushna Guna of Arka, Haridra, and Sarshapa on a local level. Katu Vipaka, Vranashodana, and Vranaropana are attributes of Haridra and SarshapaTaila.
TREATMENT REGIMEN:
| PROCEDURE |
DRUGS
DOSESROUTE
DURATIONFOLLO UP
|Local application
Arka taila
sufficent amount of taila(Morning and Evening)
bahya lepanartha (local application on affected areas)
21 days
6 month
|Shaman Aushadh
Navkarshika kwatha
Twice a day
10 to 20ml
(Morning and
Evenin)(before meal)
oral
21 days
6 month
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age 16-70 years 2.Patient who fulfill the diagnostic criteria.
- •3.Disease chronicity less than 3 years.
- •4.Previous diagnosed patients.
- •5.Patients who have given written consent to participate in the study.
排除标准
- •1.Lactating and Pregnant women.
- •2.Patients who are not willing to give written consent to participate in the study.
- •3.Patients who have undergone any major or minor surgery.
结局指标
主要结局
Improvement in subjective parameters like itching, depigmentation, eruption, roughness, burning.
时间窗: from 0 to 21 days
次要结局
- To assess the effect of trial drugs in improving(the signs, symptoms as per assessment criteria.)
研究者
Dr Shivani Lowanshi
Govt. Ayurvedic College Nipaniya Rewa
