FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/11/022029 [Registered on: 18/11/2019] Trial Registered Prospectively
Last Modified On: 15/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Ayurveda and Homeopathy in Common Cold 
Scientific Title of Study   An Integrated Approach In The Management Of Allergic Rhinitis – A Randomised Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashekhar V Sanapeti 
Designation  Associate Professor 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Associate Professor 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi


KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajashekhar V Sanapeti 
Designation  Associate Professor 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi


KARNATAKA
590003
India 
Phone  9611442881  
Fax    
Email  rajashekharpk@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
 
Primary Sponsor  
Name  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajashekhar V Sanapeti  KLE Ayurveda Hospital  OPD no 04 and IPD of KLE Ayurveda Hospital Shahapur Belagavi - 590003
Belgaum
KARNATAKA 
9611442881

rajashekharpk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHERs Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J308||Other allergic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Homoeopathic treatment   Allium cepa Arsenicum album Euphrasia officinalis Silicea Sabadilla Kali Carb Arum triphyllum Dulcamara Nux Vomica Hepar sulph Drugs will be administered orally in ectract form and dose prescribed is beginning will be 30 followed by 200 and 1 M. for 6 months 
Intervention  Shodhana chikitsa followed by Homoeopathic treatment   1-2 year chronic Deepana Pachana with orally Chitrakadi vati 2 bd, B / F or Vyoshadi vati 1 tid A / F Shiro – Virechana Nasya with Guda-nagar swarasa 8 drops each nostrils For 7 days Purvakarma – Stanika abhyanga with Nirgundi taila, Nadi sweda Paschat karma – Dhoomapana and Kavala with Triphala+ Yasti + Haridra + Saindhava lavana 2 year onwards Deepana Pachana with orally Chitrakadi vati 2 bd, B / F or Vyoshadi vati 1 tid A / F Koshta shodhana with Gandharva hastadi castriol – 30 ml + Ksheera – 60 ml Shiro – Virechana Nasya with Shadbindu taila 10 - 12 drops each nostrils For 7 days (Purvakarma – Stanika abhyanga with Nirgundi taila, Nadi sweda Paschat karma – Dhoomapana and Kavala with Triphala+ Yasti + Haridra + Saindhava lavana)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient presenting with the Symptoms of Allergic Rhinitis
Either sex
Fit for Shodhana treatment
 
 
ExclusionCriteria 
Details  Cases with gross nasal pathological changes like DNS, Nasal polyps, chronic sinusitis, any other nasal tumors
Complications affecting the lower respiratory system like pneumonia, asthma etc.,
Patients on immune suppressants
Associated with Systemic diseases, pregnant woman
Cases coming out with symptoms other than these 10 remedies included in research will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Integrated protocol is beneficial   10th day
30th day
60th day
90th day
120th day
150th day
180th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   02/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

—  Allergic Rhinitis a disease pertaining to Nose, induced by an immunoglobin E (IgE)-mediated inflammatory reaction after allergic exposure of the membranes lining the nose and is characterized by watery Nasal discharge, Nasal congestion, Sneezing and Itching in the nose1. Allergic rhinitis is the most common type of chronic rhinitis, affecting 10 to 20% of the population, and evidence suggests that the prevalence of the disorder is increasing2. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance3

Most cases of Allergic Rhinitis respond to pharmacotherapy. Patients with intermittent symptoms are often treated adequately with oral antihistamines, decongestants, or both as needed. Regular use of an intranasal steroid spray may be more appropriate for patients with chronic symptoms. Daily use of an antihistamine, decongestant, or both can be considered either instead of or in addition to nasal steroids4.

Anti-histamines relieve the symptoms temporarily and in addition it may lead to side effects like drowsiness or sedation, dryness of mouth, suppressing of appetite but avoidance of allergens or desensitization against the allergens is the ideal methods to avoid Allergic Rhinitis but these are not always possible.

Allergic rhinitis mimics lakshanas of Vataja Pratishyaya which is a Nasagataroga and one among five types of Pratishyaya5

Panchakarma (Shodhana - biopurificatory)  treatments will eliminate the morbod factors responsible for the genesis of disease6 and are proved effective in the management of Allergic Rhinitis (Pratishyaya). Panchakarma treatments will boost the immune system and can prevent recurrent episodes of Allergic Rhinitis7. Vamana karma (Theraupetic Emesis) / Virechana (Therapeutic Purgation) / Nasya (Errhine) karma are  Shodhana procedures that eliminate morbid Kapha dosha and thereby removing the allergens out of the body.

Homeopathy is safe and effective way to treat AR, which also decreases the recurrence of symptoms due to its influence on vital force and will trigger the body’s natural defences. Medicines are prescribed on the basis of symptom similarity. Homeopathic medicine stimulates the body’s own defense system to cope with exposure to allergens, rather than suppressing the allergic symptoms. Often, treatment doesn’t have to be taken continuously – for example, a homeopathic medicine taken at the begining of allergic rhinitis and can be repeated every month till the episodes and intensity of symptoms decreases8

 

With this background here is an attempt made to find out effective treatment of homoeopathic formulation to treat Allergic rhinitis along with Panchakarma (purifactory process) of an Ayurveda and its efficacy to prevent recurrent episodes. So the formulations which are explained in the treatment of Allergic rhinitis have been selected for the present study those are constitutional approach of homoeopathy and integrated approach of Ayurveda. So present study is aimed to know the efficacy and safety of these formulations in the management Allergic rhinitis.  

 
Close