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临床试验/CTRI/2023/07/054849
CTRI/2023/07/054849已完成不适用

A Clinico-Comparative study on the effect of Virecanakarma with Kalyāṇaka guḍa and Māṇibhadra guḍa on Inflammatory markers in Kiṭibhakuṣṭha (Psoriasis)

S.V. Ayurvedic college and hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
To prove the Anti-inflammatory effect of Virecanakarma by comparing the efficacies of Kalyāṇaka guḍa & Māṇibhadra guḍa by evaluation of Inflammatory markers

研究概览

简要总结

KusÌ£tÌ£ha is mentioned in Ayurvedic classics as an obstinate skin disorder which comes under the spectrum of Raktaja vikaÌ„ra’s (Ca.Su.24/16, Ca.Su.28/11). Among eleven types of KsÌ£udrakusÌ£tÌ£ha, KitÌ£ibhakusÌ£tÌ£ha is a condition in which there is vitiation of VaÌ„ta and Kapha dosÌ£a’s. Acharya VÄghbaÅ£a mentioned KuÅŸÅ£ha as an indication of Virecana karma. Virecana is also considered as one of the important therapeutic options that has to be explored in the management of Rakta DusÌ£tÌ£i janya vikaÌ„ra’s (Ca.Su.24/18).

In modern parlance KitÌ£ibha can be co-related with Psoriasis. It is a genetically determined, auto immune kind of inflammatory skin disorder, the pathogenesis of which is still enigmaticin contemporary medicine. Cytokines play an important role in the pathophysiology of Psoriasis. Serum inflammatory markers are the important components of Cytokines and Interleukin -6 (IL-6)is one of the essential variety of Serum inflammatory markers, which could be found in high levels in lesional skin and in the peripheral blood of Psoriatic patients. High-sensitivity CRP (hs-CRP) is one among the inflammatory markers used to detect chronic inflammation and it measures low levels of CRP. An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. It’s an indirect marker of the inflammation levels in the body, because when inflammation is high, it takes longer for the red blood cells to drop. Systemic immune inflammation index (SII) is also an inflammatory marker. The SII was calculated by the formula: neutrophil x platelet/lymphocyte, Neutrophil-lymphocyte ratio (NLR), monocyte-lymphocyte ratio (MLR) and platelet-lymphocyte ratio (PLR).A PASI score is a subjective tool used to measure the severity and extent of Psoriasis (Psoriasis Area and Severity Index), which will be helpful to assess the inflammatory status of psoriasis.

Hence, in the present study it has been proposed that IL-6, hs CRP, ESR, SII (Systemic Immune Inflammation Index), in combination with PASI Score have been considered as inflammatory markers to assist in assessing disease severity and response to treatment in patients with psoriasis.

In Caraka saṃhita Kalpa Sthāna, Kalyāṇaka guḍa is mentioned in Syāma Trivruth Kalpa, which has been indicated in the management of Kuṣṭha by inducing Virecana (C.Ka.7/40-45).

Similarly, in Aṣṭāṅga Hṛdaya Cikitsā sthāna, Māṇibhadra Guḍa is mentioned in Kuṣṭha Cikitsā for inducing Virecana (A.H.Ch.19/31-32).

 Thus, the present study is entitled as “A Clinico-Comparative study on the effect of Virecanakarma with KalyaÌ„nÌ£aka gudÌ£a and MaÌ„nÌ£ibhadra gudÌ£a on Inflammatory markers in Kiá¹­ibhakuṣṭha (Psoriasis)â€.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group 18-65 years.
  • Patients presenting with the signs and symptoms of KitÌ£ibha.
  • Patients presenting with the signs and symptoms of Psoriasis.
  • Patients who are eligible for Virecana.

排除标准

  • Patients below the age of 18 and above the age of 65 years.
  • Patients with Diabetes and Hypertension.
  • Patients with TB, HIV, Cancer and other major systemic diseases.
  • Patients who are not eligible for Virecana.

结局指标

主要结局

To prove the Anti-inflammatory effect of Virecanakarma by comparing the efficacies of Kalyāṇaka guḍa & Māṇibhadra guḍa by evaluation of Inflammatory markers

时间窗: At baseline, aftr completion of treatment (11th-18th day), 7weeks

次要结局

  • To prove the Anti-inflammatory effect of Virecanakarma by comparing the efficacies of KalyaÌ„nÌ£aka gudÌ£a & MaÌ„nÌ£ibhadra gudÌ£a by evaluation of Inflammatory markers(At baseline, after completion of treatment( 11th-18th day), aftr 7weeks)

研究者

发起方
S.V. Ayurvedic college and hospital
申办方类型
Government medical college

研究点 (1)

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