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CTRI Number  CTRI/2023/05/052294 [Registered on: 04/05/2023] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effect of 18 types of food combination on psoriasis 
Scientific Title of Study   To study the role of Ashtadasha Viruddha Ahara in the etiopathogenesis of Ekakushtha with special reference to Psoriasis-A case control study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarti Devi 
Designation  MD scholar 
Affiliation  institute of teaching and research in Ayurveda Jamnagar 
Address  Department of rog nidan and vikriti vigyan fifth floor institute building ITRA

Jamnagar
GUJARAT
361008
India 
Phone  9041287614  
Fax    
Email  bkaartid@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chinmayi C Shah 
Designation  Reader 
Affiliation  Institute of teaching and research in Ayurveda Jamnagar 
Address  room no 517 fifth floor department of rog nidan and vikriti vigyan institute building ITRA

Jamnagar
GUJARAT
361008
India 
Phone  9998964805  
Fax    
Email  drcu_16@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chinmayi C Shah 
Designation  Reader 
Affiliation  Institute of teaching and research in Ayurveda Jamnagar 
Address  room no 517 fifth floor department of rog nidan and vikriti vigyan institute building ITRA

Jamnagar
GUJARAT
361008
India 
Phone  9998964805  
Fax    
Email  drcu_16@hotmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research In Ayurveda Jamnagar Gujarat 361008  
Address  opposite reliance mart ITRA Jamnagar 
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 Aarti Devi  ITRA hospital Jamnagar  OPD No 16 Department of roga nidana and Vikriti vijnana,Institute of Teaching and research in ayurveda hospital, Opp city B division police station,Pn Marg,Jamnagar,Gujarat 361008
Jamnagar
GUJARAT 		 9041287614

bkaartid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age and gender matched healthy individuals who have Annabhilasha, Bhuktasyaparipakasukhena, sukhaswapanprabodhan, prashannendriya, Srishtavitta-mutra-vata, bala-varna smaagnit, shareeralaghava, saumanasya will be selected as control 
Patients  (1) ICD-10 Condition: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age between 18 yrs. to 60 yrs
Patients willing to participate and follow study protocol
Patients with the chronicity of 2 years
Patients with controlled DM (FBS ≤130mg/dl) and HTN (systolic B.P.-110-140 mm of Hg and diastolic-70-90mm of Hg) and who follow regular medication for the same
 
 
ExclusionCriteria 
Details  Patients of age < 18 yrs. & >60 yrs. of age
Patients not willing to abide by study protocol
Patients with the chronicity of >2 years
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the exposure of eighteen types of Viruddha Ahara in ekakushtha and psoriasis patients  0ne day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/05/2023 
Date of Study Completion (India) 15/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/09/2024 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Present work is a case control study for which 48 subjects had been recruited in each group to assess the Ashtadsha Viruddha Ahara in the context of Ekakushtha. In case group, patients of Ekakushtha diagnosed according to presence of general symptoms of Ekakushtha like Aswedanam (absence of sweat), Mahavastu (which covers large area) and Matsyashakalawat twacha (skin resembles scales of fish) are considered along with the current gold standard for assessment of extensive psoriasis i.e. Psoriasis Area and Severity Index (PASI) between the age of 18 yrs to 60 yrs. and chronicity 2 yr. were enrolled. Whereas in control group age and gender matched healthy individuals were selected. A closed ended questionnaire containing demographic details, Ashthadasha Viruddha Ahara on the basis of classics and present times with relevant examinations was prepared and used for data collection. In both group hemoglobin, complete blood count, fasting blood sugar, lipid profile, renal profile, were carried out to rule out any other pathology condition.

Obtained data from survey of case and control groups had been presented in tabular form and statistical tests such as chi square, odds ratio and confidence interval (CI) were applied and interpreted. In this study, maximum participants observed were of age group 51-60 yrs. (case and control- 29.16 each), male (case and control-52.1% each), Hindu (case-91.67%, control- 93.75%), married (case-77.1%, control- 83.33%), urban resident (case- 56.3%, control- 45.83%), Jangala Desha (case- 97.6%, control- 83.33%), graduate (case- 37.5%, control- 47.91%), housewife (case- 37.09%, control-32.25%) and middle class (case- 64.6% , control-75% and 80.64% respectively).

on comparing the data from case and control group both (OR and chi square are highly significant for Paka Viruddha Ahara (OR – 9.0 chi square 20.3) Matra Viruddha Ahara (OR 10.52 chi square 26.3) Vidhi Viruddha Ahara ( OR 11.4 , chi square 28.2 ) Desha Viruddha Ahara ( OR 18.8, chi square 35.8 ) Kostha Viruddha Ahara ( OR 21, chi square 38.09) significant for Samyoga Viruddha Ahara ( OR 3.7, chi square 9.5 ) Kala Viruddha Ahara (OR 2.6, chi square 5.15 ) Parihara Viruddha Ahara ( OR 10.4 ,chi square 12.0 ) Upchara Viruddha Ahara ( OR 20.35 chi square 8.72) Virya Viruddha Ahara ( OR 4.1 chi square 8.7 ) Krama Viruddha Ahara ( OR 10.12, chi square 8.7 ) Samskara Viruddha Ahara ( OR 10.12 ,chi square 15.03) Sampada Viruddha Ahara ( OR 47, chi square 28.61 ) Hridya Viruddha Ahara ( OR 28.20 ,chi square 18.96 ) Agni Viruddha Ahara ( OR 3.66, chi square 4.8 ) Dosha Viruddha Ahara ( OR 7.27 chi square 14.89 ) insignificant for Satmya Viruddha Ahara ( OR 0.31, chi square 1.04 ) Avastha Viruddha Ahara (OR 1.69 chi square 1.56 ).

It shows that Ashtadasha Viruddha Ahara play significant role for manifestation of diseases.

Thus, we can conclude null hypothesis is rejected and alternate hypothesis i.e., there is a positive role of Ashtadasha Viruddha Ahara in the etipathogenesis of Ekakushtha with special reference to Psoriasis is accepted.

 
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