FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045654 [Registered on: 19/09/2022] Trial Registered Prospectively
Last Modified On: 05/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management in Urticaria 
Scientific Title of Study   A Clinical studty to evaluate the Role of Virechanottara Udwartana in Sheetapitta with special reference to Chronic Urticaria 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uma Mantha 
Designation  PG Scholar 
Affiliation  Dr. BRKR Govt Ayurvedic Medical College 
Address  Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad 500038
Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad 500038
Hyderabad
TELANGANA
500038
India 
Phone  9491854040  
Fax    
Email  dr.umabutta71@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Praveen Kumar 
Designation  Associate Professor 
Affiliation  Dr. BRKR govt Ayurvedic Medical College 
Address  Room No 5, Panchakarma O.P. Dr. BRKR Govt Ayurvedic Medical College, S.R. Nagar, Hyderabad
Room No 5, Panchakarma O.P. Dr. BRKR Govt Ayurvedic Medical College, S.R. Nagar, Hyderabad
Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Uma Mantha 
Designation  PG Scholar 
Affiliation  Dr. BRKR Govt Ayurvedic Medical College 
Address  Room No. 5, Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad 500038
Dr. BRKR Govt Ayurvedic Medical College , S.R.Nagar Hyderabad 500038
Hyderabad
TELANGANA
500038
India 
Phone  9491854040  
Fax    
Email  dr.umabutta71@gmail.com  
 
Source of Monetary or Material Support  
Dr.BRKR Govt Ayurvedic Medical College Hyderabad. 
 
Primary Sponsor  
Name  Dr BRKR Govt Ayurvedic medical college 
Address  Dr. BRKR Govt Ayurvedic Medical College S.R.Nagar Hyderabad Telangana 500038 
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 
Dr M Uma  Govt Ayurvedic Hospital   Room no 5,Department of Panchakarma, Govt Ayurvedic Hospital, S.R. Nagar, Hyderabad.
Hyderabad
TELANGANA 
9491854040

dr.umabutta71@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:L50||Urticaria. Ayurveda Condition: SITAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AByantarasnehaH , आभ्यन्तर स्नेहः (Procedure Reference: Baishajya Ratnavali, Procedure details: Mahatiktaka gritha )
(1) Medicine Name: Triphaladi Yoga, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Baishajya Ratnavali, Procedure details: Sarshapa Taila)
(1) Medicine Name: Sarshapa taila, Reference: Baishajya Ratnavali, Route: Otic, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 3 Days
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Baishajya Ratnavali, Procedure details: Triphaladi yoga with Eranda taila)
(1) Medicine Name: Triphaladi Yoga, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Duration: 1 Days
4Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Baishajya Ratnavali, Procedure details: Siddarthakadi Yoga)
(1) Medicine Name: Siddarthakadi Yoga, Reference: Baishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 150(g), Frequency: sos, Duration: 14 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Urticaria more than 6 weeks.
2 Patients fit for Purgation therapy vis a vis Virechana karma. 
 
ExclusionCriteria 
Details  1 Urticaria less than 6 weeks duration
2 Patients suffering with other skin diseases such as Eczema, Psoriasis
3 Patient unfit for Purgation therapy vis a vis Virechana karma
4 Tuberculosis, HIV, HbsAg
5 Major systemic disorders, un controlled Diabetes
6 Patients suffering with Severe form of Angioedema
7 Drug induced Urticaria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Average change from baseline in following parameters: 1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals.  Assessment done on base line visit (day 0), and after 4 weeks of treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
To Improve the quality of life  Assessment done on base line and after8 weeks of treatment
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1 
Date of First Enrollment (India)   19/09/2022 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Chronic Urticaria (CU) is a common dermatological condition affecting an estimated 15-20% of the general population at least once during the life time. Urticaria causes inconvenience in family structures, compromising performance at work, school, and negatively impacting on leisure activities.

Urticaria is a mast-cell-driven disease. Histamine and other mediators, such as platelet-activating factor (PAF) and cytokines released from activated mast cells, result in sensory nerve activation, vasodilatation, and plasma extravasations as well as cell recruitment urticarial lesions.

Contemporary modern medicine does not have complete cure for Urticaria. Modern second-generation antihistamines are considered as the first-line symptomatic treatment for urticaria and these medicines have undesirable side effects such as drowsiness, dry mouth, weight gain and increased resistance to infections.

The symptoms of urticaria is comparable to sheetapitta. The main focus of the present therapies aimed at symptomatic relief. Panchakarma therapies helps in cleansing the body and also helps in detoxification. The hyper immune response is seen in urticaria is countered effectively with panchakarma therapies. Virechana karma is one among the panchakarma therapy. Virechana Karma is a simple method of shodhana therapy which acts on sleshmasamsrusta pittaja vyadhi. After samshodhana, udwarthana can be used to ensure better results in sheethapitta vis-a vis Urticaria.

This study is designed as single arm study in patients with Virechanottara Udwarthana. After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on baseline, 10th and 50th day of treatment. This includes subjective assessment of general wellbeing, weekly UAS7 scores and physical examination. The total duration of treatment will be 50 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. 


 
Close