Management of Psoriasis in children by Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as Internal and Narseeraga Thailam as External

Phase 2

Completed

• Conditions: Other disorders of the skin and subcutaneous tissue,

• Registration Number: CTRI/2023/10/058492
• Lead Sponsor: National Institute Of Siddha

Brief Summary

**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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-15
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Weekly once

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ayothidoss Pandithar hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Megganah

Principal investigator

6381372797

drmegumd@gmail.com