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CTRI Number  CTRI/2024/12/077835 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Evaluate The Efficacy Of Siravedhan And Durvadi Lepa Together In The Management Of Urticaria(sheetpitta) in age group of 20-60 years.  
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Siravedhan And Durvadi Lepa Together In The Management Of Sheetpitta With Special Reference To Urticaria In Age Group Of 20-60 Years  
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 Kirti Rajesh Dudhe 
Designation  PG Scholar 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalay and L.K. Ayurved Rugnalaya Yavatmal 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD No.5 Yavatmal MAHARASHTRA 445001 India

Yavatmal
MAHARASHTRA
445001
India 
Phone  9284030890  
Fax    
Email  kirtidudhe7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrLaxminivas Rajgopalji Soni 
Designation  Professor and HOD Shalyatantra 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalay and L.K. Ayurved Rugnalaya Yavatmal 
Address  DMM AYURVED MAHAVIDYALAYA ARNI ROAD SHIVAJI NAGAR , YAVATMAL
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD No.5 Yavatmal MAHARASHTRA 445001 India
Yavatmal
MAHARASHTRA
445001
India 
Phone  9422281424  
Fax    
Email  lrsoni10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kirti Rajesh Dudhe 
Designation  PG Scholar 
Affiliation  Dayabhai Maoji Majithiya Ayurved Mahavidyalay and L.K. Ayurved Rugnalaya Yavatmal 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD No.5 Yavatmal MAHARASHTRA 445001 India
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD No.5 Yavatmal MAHARASHTRA 445001 India
Yavatmal
MAHARASHTRA
445001
India 
Phone  9284030890  
Fax    
Email  kirtidudhe7@gmail.com  
 
Source of Monetary or Material Support  
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Shivaji nagar, Aarni road, Yavatmal 445001  
 
Primary Sponsor  
Name  DMM Ayurved Mahavidyalaya Yavatmal 
Address  Dayabhai Maoji Majithiya affiliated with L.K. Ayurved Rugnalaya, Department of Shalaytantra, Ground floor OPD No.5,Shivaji Nagar, Yavatmal,Arni road Dist.Yavatmal 445001  
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 Kirti Rajesh Dudhe   L.K.Ayurved Rugnalaya,Yavatmal  Department of Shalyatantra, Division 1,Room no 5, Shivaji nagar, Aarni road, Yavatmal 445001 MAHARASHTRA
Yavatmal
MAHARASHTRA 		 9284030890

kirtidudhe7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee D.M.M Ayurved Mahavidyalaya Yavatmal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Sushrut Sharir Sthan8/5 page no.241, Procedure details: PURVAKARAM: 1. First of all, Before a treatment day Sardvehik snehana with lukeworm Tila Taila will be done all over the bodyAfter that Taap Swedana will be given to the area. 3.Liquid diet will be given to patient.23 PRADHANKARAM: 1) The patient should be lying on the table. 2) A tourniquet must be applied above the elbow joint. 3) Vein should be selected on the cubital fossa in the right hand. 4) The area will be cleaned with spirit swabs. 5) The needle scalp vein set will be inserted into the desired vein. 6) The flowing blood will be collected in a measuring cylinder. 7) when the blood flow reduces, remove the tourniquet and scalp vein set. 8) Upto 180 ml of blood will be drained out in first sitting then after 15 days 180 ml be drained and again in the next 15 days 180 ml of blood will be drained out in this way in 3 sitting total 540 ml i.e Pradhan-matra of Raktamokshana is achieved.23 PASCHATKARAM: 1) A Tight Bandage will be applied on the punctured area.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient between 20to 60year of age will be selected,
2.Gender:Any sex
3.Patient belonging to any socio economic class
4.Cast: Irrespective of cast 
 
ExclusionCriteria 
Details  1.Patient unwilling to participate in the trial.
2. Vrudh (age more than 60 years)
3. Balak (age less than 20 years)
4.Garbhini(pregnant and lactation mother)
5.Pandu(anemia)
6.Shoth
7.Shatshin
8.Shawas(asthma)
9.Shosh(T.B)
10.Ashepak (convulsion)
11.upwas-pipasa
12.vamit,virikat
13.Alocholic
14.Eczema,Skin Disease
15.Patient with major illness like Cancer, CRF, CHD, ARF, COPD, Angioedema,
Chickengunia 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The parameters will be noted down before and
after treatment.
Varati dashta samsthana
Shotha( Wheals)

2.Kandu

3.Toda
(Local Pricking pain)

4.Chhardi (vomiting)

5. Jwara
(Fever)

6.vidah

7.Sarang Mandal
(circular patches)
 		 Study:1st, 15th, 30th, day then follow up will be taken on 1st,15th, 30th day  
 
Secondary Outcome  
Outcome  TimePoints 
) CBC
2) ESR
3) ALLERGY TESTING
Above Investigation and other required investigations will be carried out to
rule out serious illness if any and whenever they are necessary. 		 Study:1st, 15th, 30th, day then follow up will be taken on 1st,15th, 30th day  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/01/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Sheetpitta is one of the disorders which is made of two word Sheet” (cold) And “Pitta”. This disease occurs due to dominance of cold (existing in kapha and vata dosha) over pitta dosha.Three dosha gets vitiated but vata vitiation is
more. Dhatu involved in this mainly rasa and rakta sheetpitta is characterized by vartidansthsansthan shoth, kandu, toda,
chhardi, jwara, vidaha1. In modern science urticaria is characterized by Itching,erythematous macules and wheals2.
 SHEETPITTA can be correlated with Urticaria. Urticaria is commonly known as hives, nettle, rash, wheals. urticaria presents with short lived itchy wheals which may be pale or pink in the centre, surrounded by a red flare
 
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