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CTRI Number  CTRI/2023/05/052556 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on kotha w.s.r. urticaria and its management with dushivishari agada and saindhavadi yoga 
Scientific Title of Study   A study on kotha with special reference to urticaria and its management with dushivishari agada and saindhavadi yoga 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RAHUL SADIWAL 
Designation  PG SCHOLAR AGAD TANTRA EVUM VIDHI VAIDYAKA 
Affiliation  Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL 
Address  Science hills behind manit kolar nehru nagar Bypass road bhopal bhopal madhya pradesh 462003 India Bhopal Madhya pradesh 462003 India
Department of agad tantra evum vidhi vaidyaka room no-228
Bhopal
MADHYA PRADESH
462001
India 
Phone  7898452041  
Fax    
Email  rsadiwal60@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR URMILA SHUKLA 
Designation  PROFESSOR AND HOD OF DEPT OF AGAD TANTRA EVUM VIDHI VAIDYAKA 
Affiliation  Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL 
Address  Room no 229 science hills behind manit kolar nehru nagar Bypass road bhopal bhopal madhya pradesh 462003 India Bhopal MADHYA PRADESH 462003 India

Bhopal
MADHYA PRADESH
462003
India 
Phone  9425672655  
Fax    
Email  drurmilashukla5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR RAHUL SADIWAL 
Designation  MD SCHOLAR AGAD TANTRA EVUM VIDHI VAIDHYAKA 
Affiliation  Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL 
Address  SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL BHOPAL MADHYA PRADESH 462003 INDIA Bhopal MADHYA PRADESH 462003 India
department of agad tantra evum vidhi vaidyaka room no 228
Bhopal
MADHYA PRADESH
462001
India 
Phone  7898452041  
Fax    
Email  RSADIWAL60@GMAIL.COM  
 
Source of Monetary or Material Support  
Pt. KHUSHILAL SHARMA GOVT.(AUTO.) AYURVEDA COLLEGE AND INSTITUTE, BHOPAL, MP 
 
Primary Sponsor  
Name  Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL 
Address  SCIENCE HILLS BEHIND MANIT, KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL BHOPAL MADHYA PRADESH 462003 INDIA 
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 rahul sadiwal  Pt khushilal sharma govt auto ayurveda college and institute bhopal  Department of agad tantra evum vidhi vaidyaka science hills Behind manit, Kolar nehru Nagar bypass Road,bhopal Bhopal madhya Pradesh 462003 India Bhopal Madhya pradesh
Bhopal
MADHYA PRADESH 
7898452041

rsadiwal60@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 
Patients  (1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: KOTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dooshivishari gutika, Reference: sushruta kalp2/30, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: medicine will be prepared in the form of gutika and prescribed to pt in bid dose
(2) Medicine Name: saindhavadi yoga`, Reference: yogratnakar sheetpittodard chapter shlok no 12, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: one medicine dooshivishari gutika will be given internally and second medicine saindhavadi yoga will be given for local application as external medicine(saindhavadi yoga will be given as required
2Comparator Arm (Non Ayurveda)-placibo 250mg capsule filled with roasted suji bid for 30 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having cardinal sign and symptoms of Kotha (Urticaria), as in Ayurvedic classics and contemporary medicine.
AEC (absolute eosinophil count value is > 500 cells/cmL
Diagnosed mild and moderate cases of Urticaria.
 
 
ExclusionCriteria 
Details  1.Patient having disease like urticaria with angioedema, diabetes mellitus, tuberculosis, severe cardiac disease,
2.Patients having major systemic illness.
3.Pregnant and lactating mothers will be excluded.
4.Patient without written consent form.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
after completion the study,we will be able to demonstrate that Dushivishari Agada and Saindhavadi yoga is effective in management of Kotha (Urticaria)  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
after completion of study i would be able to explain that Dushivishari Agada and Saindhavadi yoga are not effective in the management of Kotha (Urticaria)  30 days 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Urticaria is allergic reaction marked by multiple discrete swelling on the skin that are intensely itchy and last up to 24 hrs. it is caused by hyper  sensitivity of the immune system. In present scenario people are using many types of products and food items, containing many hazardous chemicals. Use of beverages, food adulteration, preservatives, additives, fruit ripping agents, different chemicals, pesticides are the form of artificial poison. These chemicals get deposited in the system and remain in the form of latent poison(dooshivisha acc to ayurveda).These poisons trigger the immunity of the person, which ultimately results in hyper sensitivity of the immune system. the Urticaria or hives is a common skin condition that affects population with a lifetime prevalence of up to 22% and point prevalence of 1%. Approximately 4–33% of cases are reported to be physical urticaria and 1–7% of cases are cholinergic urticaria. It is expected that at the end of study we would be able to demonstrate the efficacy of Dushivishari Agada and Saindhavadi Yoga in the management of kotha w.s.r. Urticaria.

 
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