跳至主要内容
临床试验/CTRI/2023/10/058492
CTRI/2023/10/058492已完成2 期

Single centric, Non-Randomized, An open clinical trial to evaluate the effectiveness of Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as Internal and Narseeraga Thailam as External in the management of Kalanjagapadai (Psoriasis) in children.

National Institute Of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月15日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
To evaluate the effectiveness of Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as Internal and Narseeraga Thailam as external for the management of Kalanjagapadai (Psoriasis) in Children.

研究概览

简要总结

**INTRODUCTION:**Psoriasis is defined as the characterization of proliferation of erythemato scaly eruptions, single or multiple disposed primarily on the extensor surfaces of the body. The scales are lamellated and silvery white.The incidence of Psoriasis among all age group is about 1-3 % of the world population.And the incidence of psoriasis in children increased significantly over time from 29.6 per 100,000 in 1970 to 1974 to 62.7 per 100,000 in 1995 to 1999. Chronic plaque psoriasis was the most common type (73.7%), and the most commonly involved sites were the extremities (59.9%) and the scalp (46.8%).According to the definition in the textbook of Siddha MaruthuvamSirrappu, Kalanjagapadai is described as a chronic non infectious, recurrent, inflammatory disorder of the skin characterized by reddish, slightly elevated patches covered with silvery white scales. In Siddha System, all the skin disorders are brought under the clinical entity “Kuttamâ€. The Siddha literature, Aathma Rachamirtham Ennum Vaithiya Saarasangiragam, mentions the charecteristics of Kuttam as, White scaly patches that appears in foot, hand, lips, vertex, finger and wrists. The drugs chosen for the project included Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as internal and Narseeraga Thailam as external, all of which have been used in the siddha system of medicine for centuries in various combination. In order to limit the issues of the disease the efforts were undertaken to study the result of the combination of these therapies.

MATERIALS AND METHODS: An open clinical trial will be conducted in OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai. A total number of 30 children diagnosed with Psoriasis (Kalanjagapadai) within the age  limit of 5 to 12 years who are willing to participate in the study by signing the assent and consent form, will be enrolled based on the inclusion and exclusion criteria. The trial drug of Sivanarvembu Kuzhi thailam with Sivanarvembu chooranam as internal and Narseeraga Thailam as external, will be given to the 30 children of both sex for the period of 45 days.

**RESULTS:**Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.

KEY WORDS: Kalanjagapadai in children, Psoriasis in children, Sivanarvembu Kuzhi Thailam, Sivanarvembu Chooranam, Narseeraga Thailam, PASI SCORE.

研究设计

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

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Age: 5 – 12 years 2.Sex: Both male and female children.
  • 3.Patients with two or more of the following symptoms •Erythema •Scaling •Dryness of the skin •Thickness of the skin with or without itching •Cracks followed by itching •Candle grease sign +ve •Auspitz sign +ve 4.Willing to cooperate for taking photographs whenever required with consent.
  • 5.Patients who are willing to stay in IPD Ward or willing to attend OP Dept.
  • as on required.
  • 6.Parent / Patient’s informant willing to sign in the informed consent.

排除标准

  • Psoriatic arthritis Psoriasis with evidence of any other skin diseases 1.Psoratic lesions with secondary infection 2.K/H/O Eczema 3.K/H/O Fungal infection 4.K/H/O Epilepsy 5.Any another Systemic (Cardiac) involvement.

结局指标

主要结局

To evaluate the effectiveness of Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as Internal and Narseeraga Thailam as external for the management of Kalanjagapadai (Psoriasis) in Children.

时间窗: Weekly once

次要结局

  • 1.To study the occurrence of new lesions anywhere else in the body after intake of trial medicine.(2.To improve the quality of life in Children.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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