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CTRI Number  CTRI/2024/11/076595 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Amritadi Yoga in skin disease (Sheetapitta) 
Scientific Title of Study   A Randomised Open Label Controlled Clinical Study To Evaluate The Efficacy Of Amritadi Yoga In The Management Of Sheetapitta W.s.r To Urticaria 
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 Chandan Mahajan 
Designation  Pg Scholar  
Affiliation  Jammu Institute Of Ayurveda And Research  
Address  Dept. of PG Studies in Kayachikitsa Jammu Institute of Ayurveda and Research , Kot Bhalwal road Nardani Jammu and Kashmir
Jammu Institute Of Ayurveda And Research
Jammu
JAMMU & KASHMIR
181123
India 
Phone  9103742316  
Fax    
Email  chandanmahajan15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam Gupta  
Designation  ASSOCIATE PROFESSOR  
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH 
Address  Dept. of PG Studies in Kayachikitsa Jammu Institute of Ayurveda and Research , Kot Bhalwal road Nardani Jammu and Kashmir
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH
Jammu
JAMMU & KASHMIR
181123
India 
Phone  9149696904  
Fax    
Email  drpoonamgupta03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Poonam Gupta  
Designation  ASSOCIATE PROFESSOR  
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH 
Address  Dept. of PG Studies in Kayachikitsa Jammu Institute of Ayurveda and Research , Kot Bhalwal road Nardani Jammu and Kashmir
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH
Jammu
JAMMU & KASHMIR
181123
India 
Phone  9149696904  
Fax    
Email  drpoonamgupta03@gmail.com  
 
Source of Monetary or Material Support  
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH 
 
Primary Sponsor  
Name  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH 
Address  Kot Bhalwal , Nardani ,Jammu , Jammu & Kashmir 
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 Chandan Mahajan  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH  Room no. 102 First Floor
Jammu
JAMMU & KASHMIR 		 9103742316

chandanmahajan15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ammritadi yoga, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Haridra Khanda, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients of age 20-40 yrs. will be taken for study.
2. Patients showing and also with history of classical clinical features like - Kandu, Toda,
Mandalotpatti, Daha, Jwara, Chardi.
3. Sheetapitta (Urticarial rashes).
4. Patients willing for trial. 
 
ExclusionCriteria 
Details  1. Patients suffering from any other systemic disorders like HTN, DM, IHD and HIV.
2. Patients is having any malignancy or tumour.
3. History of Angioedema.
4. Other skin diseases like Psoriasis, Eczema.
5. History of active bleeding from rashes. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE CRITERIA:
Lakshana in subjective criteria is taken from Madhav Nidana :
1.Kandu
2.Toda
3.Mandalotpatti 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Number of Mandal
Size of Mandal 		 Baseline 15th day, 30th day, 45th day 
 
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 2 
Date of First Enrollment (India)   20/11/2024 
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 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  
Sheetapitta is a condition where all three dosha gets vitiated but Vata vitiation is more.
Sheetapitta is formed with two words which are exactly opposite to each other by their
meaning. Here, Sheetapitta denotes Kapha and Vata and their combination with Pitta
Dosha. Hence Dhatus involved in this are mainly Rasa and Rakta.
In Ayurvedic texts only in Madhava Nidana Sheetapitta was explained in detail. In Samhita
causes1

given for Sheetapitta are as follows-
1. Lavanakatu rasa, Shukta,Arnal, Sarshapaatisevana.

2. Exposure to cold environment, wind, water.
3. Diwaswap, Asamyaka Vamana.
4. Keeta Dansha, Krimi Sansarga.
When person comes in contact with above causes or similar to these causes Dosha gets
vitiated. Prakupita Vata and Kapha due to ‘Sheeta Marutadi Nidana’ when mixed with
‘Pitta’ spreads internally and externally and results in to ‘Sheetapitta-Udarda-Kotha’2
.
Mostly Rasa and Rakta Dhatu get affected first. Rasa is related to Kapha Dosha and skin
also Rakta Dhatu related to pitta dosha. By this Dosha Dushya Anubandha manifestation
occurs in skin and gives rise to unique features of Sheetapitta i.e. Rash with severe burning
and itching3
.

As per, modern aspect Sheetapitta is co-related with the urticaria and described as primary
cutaneous disorder consist of a recurrent, transient, cutaneous swelling with erythema
which resolves within 24 hours without leaving any residual cutaneous signs4

. An episode
of it may start with itching followed by red elevated patches at site of itching. Scratching,
beverages, emotional conditions and exercise are provocative factors forth symptoms.
Episodes of Urticarial may continue to relapse for days, weeks, months or year if not treated
properly. Frequent attacks may hamper patient’s mental condition. Urticariais counted as
allergic reaction due to some food and have only symptomatic treatment and anti-allergic



drug. Commonly antihistaminic drugs were used for urticaria and long- term use causes
many side effects.
Treatment for Sheetapitta according to Ayurveda includes both Shodhana and Shaman
chikitsa5
. Acharya have suggested that treatment can be done as of kushtha, Amlapitta
.
Various Aushadhiyoga are mentioned for Udarda, kotha which also can be used for
Sheetapitta. Main advantage for Ayurvedic treatment is that it helps to stop the recurrence
of Sheetapitta with correct use of Shodhana, Shamanachikitsa and Pathyapathyapalana7
 
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