| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |