跳至主要内容
临床试验/CTRI/2023/05/052168
CTRI/2023/05/052168已完成2/3 期

A Randomised comparative trial to evaluate the effect of Lelitak Prayog in Mandala Kushtha with and without Kosthashuddhi w.s.r.toTwak Sharir.

National institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Assessment of change in PASI score

研究概览

简要总结

Brief summary

Short description of the primary purpose of the protocol, including the brief statement of the study hypothesis. Include publication details.

(link/reference), if anyNEED OF STUDY:

Because of the high prevalence of psoriasis, lots of Research works have already been done on its management in both allopathy and Ayurveda fields and lots of them are still going on. Each science has its own claims over the management and success rate.

The Allopathic medicine have some limitations and certain side effects as a Hepatotoxicity, Renal failure etc.

Allopathic drugs basically involve steroids which are known for their long-term side effects and withdrawal effects.

To develop a more effective and validated treatment for the betterment of the patients is the responsibility and challenge for Ayurveda practitioners.

Literary meaning of Kosthshuddhi can be correlated with internal cleaning of body. It is one of the prime and important factors for absorption and assimilation of any substance through intestinal mucosa.

Ayurveda believes in internal cleaning through drug or therapy, after internal cleaning impact of disease is decreased and action of drug is increased. Keeping above fact in mind Hypothesis was generated and study is planned.

SELECTION OF DRUG:

Trivrit has been mentioned as the drug giving Sukhvirechna and used in treatment of Kapha and Pitta predominant diseases. Since in this study Kosthashuddhi is to be done, in order to not cause any huge discomfort to the patient and Mandala Kushtha is a Kapha predominant disease Trivrit has been opted as the choice of drug.

There are a different Kalpanas mentioned in different Ayurvedic classics. Among them, Vati Kalpana is being a easy palatable form and here an attempt is made to assess the effect of Kosthashuddhi in Mandala Kushtha by administering Trivrit Ghanavati.

AIM:

To evaluate the Kosthashuddhi effect of Trivrit Ghanavati in Mandala Kushtha.

OBJECTIVES:

•To determine more clear vision on Kostha specially on Kosthashuddhi.

•To study the pathophysiology of Mandala Kushtha.

•To study the effect of Lelitak Prayog in Mandala Kushtha.

•To compare the effect of Trivrit Ghanavati and Lelitak Prayog in Mandala Kushtha.

STATEMENT OF HYPOTHESIS :

Null hypothesis(H0)

There is no effect of Kosthashuddhi by using Trivrit Ghanavati in Mandala Kushtha.

Alternative Hypothesis(H1)

There is effect of Kosthashuddhi by using Trivrit Ghanavati in Mandala Kushtha.

ASSESSMENT CRITERIA:

•Kosthshuddhi Assessment Questionare

•Ayurvedic Symptom Score

•Psoriasis Area and Severity Index (PASI Score)

INVESTIGATIONS:

•SGOT

•SGPT

•ESR

Pre and post treatment blood investigations will be done in all subjects.

FOLLOW UP:

Primary assessment to be done at baseline screening visit. Regular assessment will be done after every 15 days.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Subjects with classical sign and symptoms of mandala kushtha Subjects who are willing to participate and sign the informed consent form.

排除标准

  • Pregnant women and lactating mothers Subjects suffered from other systemic disorders Subjects taking any other medicine for mandala kushtha.

结局指标

主要结局

Assessment of change in PASI score

时间窗: 4 weeks

次要结局

  • Assessment of change in classical sign and symptoms of mandala kushtha(30 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验