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CTRI Number  CTRI/2018/03/012589 [Registered on: 15/03/2018] Trial Registered Prospectively
Last Modified On: 14/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Allergic cold and cough 
Scientific Title of Study   Comparative Randomized Clinical Trial to Evaluate the Efficacy of Marsha and Pratimarsha Nasya with Haridrakhanda orally in the management of Vataja Pratishyaya with respect to Allergic Rhinitis”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Radha kumari 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD 103 hospital block All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi-110076
OPD 103 hospital block All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road,
South
DELHI
110076
India 
Phone  9455876335  
Fax    
Email  drradhakumari2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Kundal 
Designation  Assistant professor 
Affiliation  All India Institute of Ayurveda 
Address  OPD 101 hospital Block All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi
OPD 101 hospital Block All india institute of ayurveda, shalakya dept. gautampuri sarita vihar mathura road
South
DELHI
110076
India 
Phone  7291887810  
Fax    
Email  drpankajkundal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Narayan Bavalatti 
Designation  Assistant professor 
Affiliation  All India Institute of Ayurveda 
Address  opd 102 hospital block All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi-110076
South
DELHI
110044
India 
Phone  9650715615  
Fax    
Email  eyenimi@gmal.com  
 
Source of Monetary or Material Support  
All india institute of ayurveda Gautampuri Sarita vihar New Delhi-110076 
 
Primary Sponsor  
Name  All institute of ayurveda 
Address  All india institute of ayurveda, gautampuri, sarita vihar, mathura road, ned delhi-110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Radha kumari  All india institute of Ayurveda  O.P.D-103 Hospital block, All India institute of Ayurveda mathura road Gautampuri Sarita Vihar ,New Delhi-110076
South
DELHI 
7291887810

drradhakumari2015@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  with signs and symptoms of allergic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Haridrakhanda orally, pratimarsha nasya with Anutail nasal drops   Haridrakhanda orally 6gmBD, Anutail nasal drops, 2 drops per day in pratimarsha nasya in each nostril  
Intervention  Haridrakhanda orally,marsha nasya with Anutail   Haridrakhanda orally 6gmBD, Anutail 8 nasal drops per day in marsha nasya in each nostril 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  with signs and symptoms of Vataja pratishyaya(Allergic Rhinitis)
patients is willing and able to participate in study
SFAR score less than <7; no allergic rhinitis and if SFAR score more than and equal to 7 ;allergic rhinitis 
 
ExclusionCriteria 
Details  Fever, hypertrophic rhinitis, atrophic rhinitis, rhinitis sicca, patients suffering from systemic diseases like TB, DM, etc, pregnant and lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the clinical features of Vataja Pratishyaya-(Allergic rhinitis) assessed
through the specific questionnaire and tools. 
patient will be assessed at the end of three month. 
 
Secondary Outcome  
Outcome  TimePoints 
To enhance the quality of life.  it will be evaluated after the end of the study. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/03/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The outcomes of the study will be communicated to peer reviewed journals for wider dissemination 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pratishyaya (Rhinitis) has been a major problem to the physicians since long back.

Vataja Pratishyaya (Allergic rhinitis) by word itself indicates that it is a recurrent condition and can precipitate due to Minute etiological factors.  Vata is the main dosha and Pitta, Kapha are associated doshas.

Nose is the sense organ which perform two main functions i.e. olfaction and respiration. Due to its direct contact with environment it is exposed to lots of microorganism, allergens and pollutants present in atmosphere. This disease is characterized by sneezing, running, stuffy and itchy nose, coughing, sore-throat, watery eyes, and frequent headaches.

 In Ayurveda the Shira (head) is called the root of the body as it contains Prana  and all Indriyas.  The Nasya is the choice of administration of the medicine for the diseases manifesting at Urdhwajatrugata region and nose is the gate way of Head, that means drugs administered via nose is highly effective in curing of diseases pertaining to head. It cleanses & opens the channel of head and also has influence on the function of Brain. In classics , it has mentioned that daily administration of Anu Taila  act as a preventive and curative remedy for the diseases and preserves the health of the healthy individual.

Many oral preparations have been mentioned in the Ayurvedic texts for the treatment of Pratishyaya. One amongest them is Haridrakhanda .  Haridra is the main content of it and is having antihistaminic, antibacterial, antifungal, Shothaghna, Kandughna; Trikatu is having anti-inflammatory, antirhinoviral, antibacterial, Rasayana etc. properties, Triphala is having Srotoshodhana, Rasayana, antihistaminic, anti-inflammatory, antibacterial etc. properties.

Vidanga is having anti-inflammatory, antibacterial, Rasayana, Srotoshodhaka etc. properties.

Haridrakhanda also has the properties like Medhya, Rasayana, Balya, Brimhana, Agni Deepana, Pachana, Shothahara, Jwarahara etc. which promotes the physical and mental health of the patient.

 
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