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临床试验/CTRI/2025/10/095959
CTRI/2025/10/095959尚未招募不适用

Efficacy of Panchakarma treatment protocol including Kashayadhara, Vamana and Manibhadragula in the management of Kitibha (Psoriasis) assessed with hsCRP and PASI Score - Open label Single arm Study

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
Change in hsCRP levels measured at various intervals:

研究概览

简要总结

INTRODUCTION:-

Psoriasis is a chronic, immune-mediated skin disorder marked by erythematous plaques and scaling, significantly affecting quality of life. The exact etiology of Psoriasis is still unknown, but it is believed to have a genetic component. Multifactorial inheritance, most likely a familial history of psoriasis, is found in 30% of patients. It is mediated by T-Cells. Psoriasis is seen worldwide in all races and both sexes with a prevalence from 0.1 to 3%. (1) It is associated with systemic inflammation. The blood levels of various inflammatory markers are increased in psoriasis. One of them is high-sensitivity C-reactive protein (hsCRP). The serum level of hs-CRP is increased in many inflammatory diseases like psoriasis, cardiovascular diseases, infections, arthritis, and others. In psoriasis, hsCRP is a reliable biomarker of systemic inflammatory burden, with elevated levels correlating with disease severity, beyond its role in tracking skin involvement. It also reflects the risk of associated comorbidities like cardiovascular disease and metabolic syndrome. The high-sensitivity CRP (hsCRP) test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation. As a diagnostic and prognostic tool, hsCRP is valuable for monitoring therapeutic outcomes and bridging clinical symptoms with underlying systemic pathology. In Ayurveda, the nearest entity to psoriasis is Kitibha, a Vata-Kapha predominant skin disease. Treatment focuses on balancing doshas and the removal of the morbid doshas. the treatment

principle includes repeated Shodhana, Bahirparimarjana Chikitsa, and Shamana medications. Key interventions include Vamana (therapeutic emesis), Kashayadhara (herbal decoction pouring), and Manibhadra Gula, a classical polyherbal formulation known for its detoxifying and skin-healing properties. In the present study, we are planning to determine the serum level of hs-CRP in psoriasis to its PASI score, which is a subjective method to determine the severity of the disease, when managed with Kashaya Dhara, Vamana, and Manibhadra Gula as Shamana medication.hs- CRP is an objective and more reliable method, and to have a better idea of systemic inflammatory process caused by psoriasis.

This open-label, single-arm study evaluates the effectiveness of this Panchakarma protocol in managing Kitibha (psoriasis), using PASI score and hsCRP levels as clinical and biochemical outcome measurements.

NEED OF THE STUDY:-

Psoriasis is a chronic, immune-mediated skin condition linked to systemic inflammation and reduced quality of life. High-sensitivity C-reactive protein (hsCRP), a marker of low-grade inflammation, is often elevated in psoriatic patients and offers greater sensitivity than conventional CRP tests. While CRP is a simple, cost-effective, and known prognostic marker, even though the data on hsCRP in psoriasis are limited. Ayurvedic medicine shows promise in

managing psoriasis, but its effect on inflammatory markers like hsCRP remains underexplored. This study investigates the impact of an Ayurvedic treatment protocol on hsCRP levels, aiming to assess its potential in monitoring and managing systemic inflammation in psoriasis.

OBJECTIVES:-

PRIMARY OBJECTIVE:

  1. To evaluate the effect of Panchakarma treatment protocol on hsCRP levels.

  2. To assess clinical improvement in Kitibha (psoriasis) symptoms and PASI score.

SECONDARY OBJECTIVE:

  1. To evaluate improvement in quality of life using DLQI and Skindex.

METHODOLOGY:

This study is a prospective, single-arm interventional clinical trial with an open-label design, conducted over a period of 2.5 years on diagnosed cases of psoriasis, in both outpatient and inpatient departments (OPD & IPD) of the All India Institute of Ayurveda (AIIA).

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
21.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Rasayana arhas mentioned in classics.
  • Vamana arhas mentioned in classics.
  • Duration = Up to 10 years of chronicity Patients having the clinical features of kitibha.
  • Plaque and Guttate Psoriasis.
  • PASI Score more than 7 hsCRP level (Moderate and above) Moderate- 1.0 and 3.0 mg/L.

排除标准

  • Patients with severe systemic disorders other than psoriasis.
  • Erythrodermic and Pustular Psoriasis.
  • Patients Ayogya for Snehapana.
  • Patients with known major illness like Hypertension, ischemic heart disease, Diabetes mellius,inflammatory disorders like SLE, rheumatoid arthritis.
  • Mentally ill/retarded patients.
  • Comorbidities like CRF, known case of Hepatitis B, Tuberculosis, HIV.

结局指标

主要结局

Change in hsCRP levels measured at various intervals:

时间窗: Baseline(0th day) | 14th day | 49th day | 79th day

Change in Psoriasis Area and Severity Index (PASI) score

时间窗: Baseline(0th day) | 14th day | 49th day | 79th day

次要结局

  • Change in Dermatology Life Quality Index (DLQI) and Skindex29(Patient-reported outcomes (itching, burning, discomfort))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shalini Singh

All India Institute of Ayurveda, Delhi

研究点 (1)

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