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CTRI Number  CTRI/2023/08/055953 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical evaluation of Nityavirechanakarma (By Aragwadh Phalamajja) treated with Navkarshikaguggulu in the management of Sheetapitta (urticaria)  
Scientific Title of Study   A clinical evaluation of Nityavirechanakarma (By Aragwadh Phalamajja) treated with Navkarshikaguggulu in the management of Sheetapitta (urticaria) An open labeled randomized comparative clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjay B Hadiya 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurveda college 
Address  OPD NO 5 Panchkarma department Government Akhandanand Ayurveda College Bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  6355696981  
Fax    
Email  sanjayhadiya8541@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Hemang U Raghwani 
Designation  M.D.(Ayu),Phd, Assistant professor 
Affiliation  Government Akhandanand Ayurveda college 
Address  OPD NO 5 Panchkarma department Government Akhandanand Ayurveda College Bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  9925008060  
Fax    
Email  vdhemang@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Hemang U Raghwani 
Designation  M.D.(Ayu),Phd, Assistant professor 
Affiliation  Government Akhandanand Ayurveda college 
Address  OPD NO 5 Panchkarma department Government Akhandanand Ayurveda College Bhadra

Ahmadabad
GUJARAT
380001
India 
Phone  9925008060  
Fax    
Email  vdhemang@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurveda College And Hospital 
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda college 
Address  Government Akhandanand Ayurveda College and Hospital, Bhadra Ahmedabad Gujarat 380001  
Type of Sponsor  Government 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 
Sanjay B Hadiya  Government akhandanand ayurveda college and hospital  Opd no 5,Department of panchakarma ,Akhandanand ayurveda hospital, Bhadra Ahemdabad-380001
Ahmadabad
GUJARAT 		 6355696981

sanjuhadiya8541@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L503||Dermatographic urticaria. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Navkarshika Guggulu, Reference: Bhavprakash samhita 55/09, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ch.Chi. 7/41, Procedure details: 100-150MLof Aragvadha Phalamajja Phant will be administered according to Kostha & Agni of the patient at night before sleep. Dose of medicine will be adjust until 1 or 2 Vega of semisolid or loose consistency Mala observed in next day morning. )
(1) Medicine Name: Aragwadha Phalamajja, Reference: Bhavprakash Nighantu- Haritakyadi Varga, Route: Oral, Dosage Form: Phanta, Dose: 150(ml), Frequency: hs, Duration: 15 Days
3Intervention ArmDrugClassical(1) Medicine Name: Navakarshika Guggulu, Reference: Bhavprakash Samhita 55/9, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having minimum two classical signs and symptoms of Sheetapitta like
varatidashtasansthan vat shoth, Kandu 
 
ExclusionCriteria 
Details  Patient having age less then 18years and more than 60years will be excluded.
Disease like, Angio edema, Diabetes mellitus, T.B.infection, Myocardial infarction,
Congestive cardiac failure, various kind of Leprosy, AIDS and other systemic disorders that
may lead fatal condition will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The efficacy of treatment will be assessed on the basis of the diagnostic criteria.
varatidashtasansthanvat shoth,kandu,toda,chardi,vidah 		 Follow up will be taken after the completion of treatment for every week up to 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Patient will be assessed on the basis of Vartidashtasansthanvatshoth,kandu,toda,chardi,jwara,vidaha  follow uo will bw taken after the completion of treatment for every week up to 2 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 14/05/2024 
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)   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   According to Ayurveda Due to excessive use of Asatmya and ViruddhaAahara nowadays Sheetapitta became most common. Prevalence of Urticaria is about 8.8–20% of individuals in the community experience an attack of urticaria at least once in their lifetime.In modern science it is being cured by antihistamines, corticosteroids, and immunotherapy, which can produce adverse effects on the body. In Ayurveda very few research works have been done on Sheetapitta. Skin disorder is not always painful to the body but it generates pain in the mind of a person who is suffering. Every individual tries to maintain his dignity in the society but along with skin problem individual feels embarrassed in every social activity. For such people, Ayurveda is one of the authentic sciences which creates hope for the betterment.Here the study is selected to find out simple, sure and effective medicament for Sheetapitta which have least or no side effect. For this purpose, Nityavirechanakarma with navakarshikguggulu selected as trial and only Navakarshikguggulu from as standard drug mentioned for Sheetapitta from BhavprakashNighantu. 
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