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CTRI Number  CTRI/2023/10/058492 [Registered on: 10/10/2023] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Preventive 
Study Design  Other 
Public Title of Study   Management of Psoriasis in children by Sivanarvembu Kuzhi Thailam with Sivanarvembu Chooranam as Internal and Narseeraga Thailam as External 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megganah 
Designation  PG Scholar 
Affiliation  National Institute Of Siddha 
Address  Room No:9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  6381372797  
Fax    
Email  drmegumd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Vennila 
Designation  Associate Professor 
Affiliation  National Institute Of Siddha 
Address  Room No:16, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789093986  
Fax    
Email  gvennils@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megganah 
Designation  PG Scholar 
Affiliation  National Institute Of Siddha 
Address  Room No:16, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  06381372797  
Fax    
Email  drmegumd@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
 
Primary Sponsor  
Name  National Institute Of Siddha 
Address  Ayothidoss Pandithar Hospital,National institute of Siddha,Tambaram Sanatorium,Chennai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Megganah  Ayothidoss Pandithar hospital  Room No:16, Department of kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Kancheepuram, TAMIL NADU, Chennai_47, India
Kancheepuram
TAMIL NADU 		 6381372797

drmegumd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee,National Institute Of Siddha,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  SIVANARVEMBU KUZHI THAILAM WITH SIVANRVEMBU CHOORANAM (INTERNAL) AND NARSEERAGA THAILAM (EXTERNAL)  INTERNAL MEDICINE: 1.SIVANARVEMBU KUZHI THAILAM: Dosage: Kaasedai (400 mg), BD After food 5-7 years: 130mg 8-12 years: 200 mg Vehicle : Sivanarvembu chooranam Duration : 45 days Route of Administration: Oral Frequency: once in a week 2.SIVANARVEMBU CHOORANAM: Dosage: Verugadiyalavu (1.3-1.5 gm), BD After food 5-7 years: 500 mg 8-12 years: 750 mg Vehicle : Sivanarvembu kuzhi thailam Duration : 45 days Route of Administration: Oral Frequency: once in a week EXTERNAL MEDICINE: NARSEERAGA THAILAM: Required quantity 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details   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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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.
 		 7 days once 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/10/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 “Kuttam”. 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.
 
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