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临床试验/CTRI/2025/02/081429
CTRI/2025/02/081429尚未招募3 期

Efficacy of Virechana Karma Followed by Vishaghna Mahakashaya Siddha Yoga Basti in the Management of Sheetapitta W.S.R. to Urticaria:An Open Labelled Randomized Standard Controlled Clinical Trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
It is expected that trial protocol will provide relief in sign and symptoms of Sheetapitta(Urticaria) It may bring changes in the level of IgE, AEC, ESR

研究概览

简要总结

Introduction:

Ayurveda explain a variety of skin disease caused by various causative factors amongst which the most common being Asatmya Sevana. Sheetapitta is a skin condition caused by exposure to allergens but the exact pathology is not known. It may be caused by a prolonged intake of Asatma Ahara. Sheetapitta is vaatika predominance along with Kapha and Pitta has Sheeta Maruta Sparsha as causative factor. We generally co-relate it with Urticaria. The word Urticaria is derived from latin word urtica which means stinging nettle. A transient redness and swelling of skin with itching, causing wheals in dermis or large hypo-dermal swelling, is called urticaria. The physical symptoms, urticaria can also have a  significant impact on patients quality of life, affecting and psychological well-being.

Significance:

Urticaria present a significant global health challenges dur to its sudden onset and potential for allergic reactions. The worldwide incidence is 0.1%-3% of the population with women affected twice more likely than men. It is estimated that about 1 in 5 people will have urticaria once in their lifetime and this seems to be the case across all age groups. Up to 1% of the population suffer from chronic urticaria and all age groups appear to be affected, although the peak incidence in between 20 and 40 years of age.

Aims and Objective

To asses and evaluate the effect of Virechana karma followed by Vishaghna Mahakashaya Siddha Yoga Basti in management of Sheetapitta w.s.r. to urticaria.

Material and Methods:

40 Diagnosed and newly diagnosed patients of urticaria will be enrolled in two groups. Group A Patients will receive intervention with Virechana Karma Followed by Vishaghna Mahakashaya Siddha Yoga Basti. Group B patients will receive Standard drug (Tab. Cetrizine).

Result and Discussion:

Data generated during the above study will be present in a systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical Study, Pharmacological Study will be discussed.

Follow up:

After completion of therapy, follow up will be done after 4 weeks to assess the status of patients, where patients will be asked to report.

Adverse effect:

This drug have no known unwanted effect. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Willing and able to participate in the study Patient having eruption alone with any 2 or more symptoms of sheetapitta mentioned in diagnostic criteria and having Chronicity of disease less than or equal to 2 years yogya for Virechana Karma and Basti Karma as per Ayurvedic Classics.

排除标准

  • Patients of age group less than 20 years and above 60 years Disease like uncontrolled Diabetes mellitus, hypertension, heart disease or other systemic illness Pregnent and lactating women Patients Ayogya for Virechana and Basti Karma Having chronicity more than 2 years.

结局指标

主要结局

It is expected that trial protocol will provide relief in sign and symptoms of Sheetapitta(Urticaria) It may bring changes in the level of IgE, AEC, ESR

时间窗: Group-A 25-30 days | Group-B 25-30 days

次要结局

  • Improvement in Urticaria activity score UAS7(Group-A 25-30 days)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Omkumari Kumre

Institute of Teaching and Research in Ayurveda

研究点 (1)

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