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临床试验/CTRI/2022/06/042961
CTRI/2022/06/042961尚未招募2/3 期

Assessment of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti in the management of Kitibha Kushtha w.s.r. to Psoriasis - A comparative clinical trial

Parul Ayurved Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Helps in reduction of signs and symptoms of psoriasis and recurrence of the disease will be controlled.

研究概览

简要总结

Psoriasis is one of the most common dermatological diseases affecting 2% of the World’s population. In India, the prevalence of Psoriasis varies from 0.44% to 2.8%. To date, no proper curative measures are found to treat psoriasis in modern science, so it is necessary to find a safe and effective measure for Psoriasis. Psoriasis has maximum resemblance with the Kitibha kushtha mentioned as a type of Kushtha in Ayurvedic classics so can be treated as per Kushtha chikitsa. As per Ayurveda’s unique treatment, Basti karma here is an attempt to study the efficacy of  Darvyadi Niruhabasti and Panchatikta Panchaprasrutik Basti with Madanadi taila Anuvasana Basti in the management of Kitibha Kushtha (Psoriasis).

RESEARCH QUESTION:

Whether the Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti with Madanaditaila Anuvasanabasti are effective in the Yogabasti krama in the management of Kitibha kushtha w.s.r. to psoriasis?

AIM:

Comparison of the efficacy of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti along with Madanaditaila Anuvasanabasti in the management of Kitibha kushtha.

OBJECTIVES:

  • To determine the effects of Darvyadi Niruhabasti and Madanaditaila Anuvasanabasti in the management of Kitibha kushtha.
  • To determine the effects of Panchatikta Panchaprasrutik Basti and Madanaditaila Anuvasanabasti in the management of Kitibha kushtha.
  • To compare the efficacy of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti along with Madanaditaila Anuvasanabasti in the management of Kitibha kushtha.
  • To evaluate the role of Basti treatment in the management of Kitibha kushtha.

MATERIALS AND METHODS:

  • Duration of Study: 18 months
  • Study design: Randomized comparative clinical trial
  • Purpose of the study will be explained and written informed consent will be taken from every patient.
  • SOURCES OF DATA:
  1. LITERARY SOURCE: All classical, modern literature and contemporary texts including the journals and websites about the disease, drugs and procedures will be reviewed and documented for the study.
  2. PHARMACEUTICAL SOURCE: Madanaditaila for Anuvasanabasti will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurveda. Niruhabasti will be prepared at Parul Ayurveda Hospital as per proper SOPs.
  3. CLINICAL SOURCE: Diagnosed cases of Kitibha kushtha, will be selected from OPD and IPD of Parul Ayurveda Hospital, Limda, Vadodara.

TREATMENT GROUPS:

Group A (Trial group) – 20 patients will be administered Darvyadi Niruhabasti and Madanaditaila Anuvasanabasti.

Group B (Control group) – 20 patients will be administered Panchatikta Panchaprasrutik Basti and Madanaditaila Anuvasanabasti.

SUBJECTIVE CRITERIA –

  • Shyavavarna
  • Kinkhara sparsha
  • Parushatva
  • Kandu
  • Scaling

OBJECTIVE CRITERIA –

  • Auspitz sign
  • Candle Grease test
  • PASI Score

INTERVENTION:

  • Yoga Basti: 8 days
 1st day 2nd day 3rd day4th day 5th day6th day 7th day8th day
 AB NBABNBABNBABAB

Here, AB - Anuvasana Basti, NB - Niruha Basti

  • Basti Quantity: 1. Niruha Basti - 550 ml 2. Anuvasana Basti - 70 ml
  • Follow up - 15 days after treatment of 8 days

The effect of the Basti (Panchakarma therapy) will be assessed based on the following criteria – 

  • Samyak Basti Lakshanas
  • The retention time of Basti
  • Number of purisha vega
  • Possible complications after administration of Basti
  • Vital data of patients

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with clinical signs and symptoms of Kitibha Kushtha.
  • Kitibha Kushtha patients between the age group of 18 to 70 years.
  • Patients of either gender irrespective of caste and religion.

排除标准

  • Patients having other systemic disorders.
  • known case of Hypertension, Carcinoma, Tuberculosis, Infectious diseases and other life threatening disorders.
  • Patients contraindicated for Shodhana such as Pregnant & lactating women.

结局指标

主要结局

Helps in reduction of signs and symptoms of psoriasis and recurrence of the disease will be controlled.

时间窗: 8 days of treatment | After 15 days of treatment follow up

次要结局

  • There will be increased quality of life in psoriasis patients and complications of the disease will be reduced.(25 days)

研究者

发起方
Parul Ayurved Hospital
申办方类型
Research institution and hospital

研究点 (1)

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