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CTRI Number  CTRI/2025/02/081107 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   "A Study Comparing the Effects of Unbalanced Diets on Skin Health in Individuals Affected by Kitibha Kushta (Psoriasis) and Healthy Individuals" 
Scientific Title of Study   Case-Control study to assess the role of Samyoga Viruddha Ahara Kitibha Kushta 
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 Shruti  
Designation  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan, Karnataka 
Address  Department of Roga Nidana evam Vikruti Vijnyana, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan-573201

Hassan
KARNATAKA
573201
India 
Phone  8123931031  
Fax    
Email  shrutibhandi8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr NandeshMohan P 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan, Karnataka 
Address  Department of Roga Nidana evam Vikruti Vijnyana, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan-573201

Hassan
KARNATAKA
573201
India 
Phone  7204442020  
Fax    
Email  dr.srinanden@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr NandeshMohan P 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan, Karnataka 
Address  Department of Roga Nidana evam Vikruti Vijnyana, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan-573201

Hassan
KARNATAKA
573201
India 
Phone  7204442020  
Fax    
Email  dr.srinanden@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan - 573201, Karnataka, India. 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital 
Address  BM Road Thanniruhalla Hassan 573201 Karnataka India 
Type of Sponsor  Private medical college 
 
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 Shruti  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan  IPD and OPD under all the Departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan
Hassan
KARNATAKA 
08123931031

shrutibhandi8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  WHO criteria of health. 
Patients  (1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Case:

1. Subjects between age group 20 -60yrs irrespective of gender.

2. Subjects diagnosed as Kitibha Kushta based on diagnostic criteria.

3. Subjects willing to participate in the study and ready to sign informed consent form.


Control:

1. Healthy individuals (according to WHO) matched with sex and age of case group 
 
ExclusionCriteria 
Details  1. Drug induced skin disorders.

2. Patients with communicable infective disease.

3. Lactating mothers and pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
subjects fulfilling the inclusion criteria are selected for study and assessed for Role of Samyoga Viruddha Ahara in Kitibha Kushta by validated questionnaire  The Outcome will be assessed at baseline with questionnaire specially prepared for Role of Samyoga Viruddha Ahara in Kitibha Kushta 
 
Secondary Outcome  
Outcome  TimePoints 
subjects fulfilling the inclusion criteria will be selected for study and will be assessed in matched case and controls for Role of Samyoga Viruddha Ahara in Kitibha Kushta by validated questionnaire   The Outcome will be assessed at baseline with questionnaire specially prepared for Role of Samyoga Viruddha Ahara in Kitibha Kushta  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Skin diseases are one among the most common of all human health afflictions and affect almost 900 million people in the World 1.  Kitibha kushta is one among the kshudra kushta as per Charaka 2 and Sushruta3 affecting the Tridosha, Rasa, Rakta, Mamsa and Lasika, characterized by Shyava Varna, Kinakhara Sparsha, Parushya4, Ruksha Pidaka  and Ati-ugra Kandu5. From contemparary science Kitibha Kushta is analogous to psoriasis. Psoriasis is an immune mediated diseases associated with comorbidities6, 1.3% - 34.7% of individuals with psoriasis develop chronic, inflammatory psoriatic arthritis leading to joint deformity and disability 7. The prevalence of this disease is increasing day by day, at present the prevalence of psoriasis in India varies between 0.44% - 2.8% 8.  According to global psoriasis atlas (GPA) an estimated 3.59 million people in India and 125 million people Worldwide are affected by psoriasis 9. As per WHO the reported prevalence of psoriasis in countries ranges between 0.9% 10 -11.3%11and is considered the psoriasis as a global burden. Patients with this disease are more prone to face physical, emotional and socio-economical stigma in the society and have a significantly higher suicidal ideation12.

         Ahara, Nidra and Brahmacharya are described as Traya-Upastambas in Ayurveda 13. Ahara has been given more importance and considered as eminent factor1. Viruddha Ahara is unwholesome diet, that vitiates the Dosha and Rasadi Dhatus15. It is one of the potent causative factor for many mild to chronic diseases including Kushta16. Samyoga Viruddha Ahara is one among them17, which is a combination incompatibility of food. This Samyoga may be between two or more food substances18.When a person consumes diet which is Samyoga Viruddha, then it provokes the Doshas after very short time period where as other types of Viruddha Aharas require long period of Abhyasa to aggravate the Doshas19. Food- food interaction is a serious issue requiring much attention to prevent its possible harmful effects 20. In present study an attempt will be made to assess the role of Samyoga Viruddha Ahara in Kitibha Kushta.

 
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