FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030495 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 10/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of Vamana karma and Maricha choorna in the patients of sheetapitta (Urticaria). 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF VAMANA KARMA AND MARICHA CHOORNA WITH GHRITA IN THE MANAGEMENT OF SHEETAPITTA W.S.R TO URTICARIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PREETI PATEL 
Designation  M.D SCHOLAR 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA NEW DELHI 
Address  ROOM NO 725 ACADEMIC WING DEPARTMENT OF PANCHAKARMA ALL INDIA INSTITUTE OF AYURVEDA GAUTAMPURI SARITA VIHAR NEW DELHI South DELHI 110076 India

South
DELHI
110076
India 
Phone  7067495386  
Fax    
Email  patelpreeti25592@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr S H Acharya 
Designation  Professor 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA NEW DELHI 
Address  ROOM NO 701 ACADEMIC WING DEPARTMENT OF PANCHAKARMA ALL INDIA INSTITUTE OF AYURVEDA GAUTAMPURI SARITA VIHAR NEW DELHI South DELHI 110076 India

South
DELHI
110076
India 
Phone  9879550157  
Fax    
Email  dracharyadr@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S K Bhatted 
Designation  Associate Professor  
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA NEW DELHI 
Address  ROOM NO 703 ACADEMIC WING DEPARTMENT OF PANCHAKARMA ALL INDIA INSTITUTE OF AYURVEDA GAUTAMPURI SARITA VIHAR NEW DELHI South DELHI 110076 India

South
DELHI
110076
India 
Phone  8130711860  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita Vihar, New Delhi-110076 
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 
PREETI PATEL  All India Institute of Ayurveda  OPD No. 6, Department of Panchakarma, Gautampuri, Sarita Vihar, New Delhi South DELHI
South
DELHI 		 7067495386

patelpreeti25592@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- All India Institute of Ayurveda  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: SHEETAPITTA ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  MARICHA CHOORNA WITH GHRITA  Maricha Choorna 2gm with 4 ml Ghrita once a day early morning before food for 1 month  
Intervention  VAMANA KARMA FOLLOWED BY MARICHA CHOORNA WITH GHRITA  1.Classical Vamana Karma with Madanphala Yoga followed by 2. Maricha Choorna 2gm with 4ml Ghrita once a day early morning before food for 30 days 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients showing clinical features of 2.Sheetapitta Chronicity more than 6 weeks and had experienced of minimum 3 attacks
3.AEC level above 350 /cu mm
 
 
ExclusionCriteria 
Details  1.Patient Ayogya for Vamana Karma.
2.Patients Ayogya for Snehapan.
3.Other skin disease e.g. Psoriasis.
4.Pregnant Women and lactating mothers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptomatic relief based on classical sign and symptoms of Sheetapitta and UAS 7 Score.

 		 0th day,46th day,76th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.Overall improvement in quality of life.
2.Reduction in the level of AEC. 		 0th day,46th day,76th day 
 
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)   01/02/2021 
Date of Study Completion (India) 02/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  


SUMMARY

 

Sheetapitta is a clinical condition characterised by reddish rashes on the skin with severe itching. The symptomatology and treatment of Sheetapitta have been explained in detail in Ayurveda classics. The clinical presentation of Sheetapitta is similar to Urticaria in conventional science. The conventional treatment provides relief for a short period of time but is associated with adverse effects with long-term use. Various treatments are mentioned in Ayurveda classics for Sheetapitta. The study entitled “a comparative clinical study on the efficacy of Vamana karma and Maricha Choorna with Ghrita in the management of Sheetapitta w.s.r to urticaria” was carried out with the objective to compare the efficacy of Vamana Karma and Maricha Choorna with Ghrita in terms of management of sign and symptoms of Sheetapitta (urticaria) and in improving the quality of life in patients of Urticaria.

The research proposal has been endorsed by the IRB and IEC. It was registered on CTRI with no - CTRI/2021/01/030495. After procurement of raw drugs, patient enrollment was done at O.P.D and I.P.D. level of AIIA. After assessing the patients based on inclusion criteria, they were randomly assigned into two different groups A and B.  In group A, Vamana Karma followed by Maricha Choorna with Ghrita and Group B only Maricha Choorna with Ghrita was administerd.

All the subjects were assessed for Ayurveda Lakshana Scale, UAS 7, DLQI, investigations i.e., IgE, AEC, and four assessments were done in this clinical study, before treatment, after Vamana Karma, after Shamana and after follow-up.30 patients fulfilling the inclusion criteria were included in the study and randomly grouped into two. Statistically significant improvement was noticed in both groups.in this clinical study it was observed that improvement was higher in group A (Vamana karma followed by Maricha choorna with Ghrita) as compared to use of only Shamana drug.

This clinical study comprises 6 parts.

 1 – Introduction 

 2 – Litreture review

- Disease review (Ayurveda) and Disease review (Modern)

- Drug review

- Procedure review

 3 – Material & Methods

 4 – Observation & Results

 5 – Discussion

 6 – Conclusion

INTRODUCTION:

In this chapter description of the disease Sheetapitta & its Contemporary correlation, including need of study, its incidence and prevalence, selection protocol, about intervention, assessment periods and assessment criteria, objectives etc. described.

LITRETURE REVIEW:

It deals with the historical review of Sheetapitta, Nirukti, definition, Nidana, Purvarupa, Rupa, Samprapti, Sadhyasadhyata, Chikitsa and Pathyapathya of Sheetapitta.
Conceptual study on Urticaria, Causes, its types, symptoms and treatment, differential diagnosis and treatment.

Also, the general aspects of given Panchakarma procedures such as - importance of Abhyantar Snehapana, Sarvanga Abhyanaga & Sarvanga Swedana, Vamana Karma, and Samsarjana Krama with some details, indications and contraindications of all the Vamana.

A brief summary of the drugs utilised in this study is included in the drug review.The drug profile includes information about the species, Rasa Panchaka, and pharmacological activities, as well as their classical therapeutic uses.

MATERIALS AND METHODS:

This section discusses the study’s methodology i.e., criteria for selection, given interventions and procedures such as Vamana Karma. Evaluation of subjective as well as objective criteria.

OBSERVATIONS AND RESULTS:

The observations & results of 30 patient’s such as observation on age, sex, diet, and so on, are presented in the form of tables and charts. The data was statistically analysed with the help of SPSS software by using repeated major ANOVA test.

DISCUSSION:

It comprises with the discussion on disease Sheetapitta, procedures, drugs, and clinical findings as well.

CONCLUSION:

It can be concluded from this study that relapse of the disease Sheetapitta can be prevented by a Vamana Karma. For authoritative conclusion similar study may be conducted with large sample size and long-term follow-up.


 
Close