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CTRI Number  CTRI/2017/09/009900 [Registered on: 25/09/2017] Trial Registered Prospectively
Last Modified On: 26/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Yoga based cleansing methods on people suffering from recurrent cold and cough. 
Scientific Title of Study   A randomized controlled trial on “the effects of shuddhi Kriyas based yoga program on allergic rhinitis” 
Trial Acronym  SKYP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh SK 
Designation  Assistant Professor 
Affiliation  Swami Vivekananda Yoga University 
Address  Division of Yoga and Physical Sciences Swami Vivekananda Yoga University [SVYASA] 19 Eknath Bhavan Gavipuram Circle K G Nagar

Bangalore
KARNATAKA
560 019
India 
Phone  9844118748  
Fax  8022639918  
Email  rajesheskay@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ripudaman Singh Chauhan 
Designation  PhD scholar, Division of life sciences 
Affiliation  Morarji Desai Institute of NAturopathy and Yogic sciences 
Address  Balwantray Mehta Arogya Bhavan Near Keshav Garden Karelibaug

Vadodara
GUJARAT
390022
India 
Phone  8141092382  
Fax    
Email  drripudaman84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ripudaman Singh Chauhan 
Designation  PhD scholar, Division of life sciences 
Affiliation  Morarji Desai Institute of NAturopathy and Yogic sciences 
Address  Balwantray Mehta Arogya Bhavan Near Keshav Garden Karelibaug

Vadodara
GUJARAT
390022
India 
Phone  8141092382  
Fax    
Email  drripudaman84@gmail.com  
 
Source of Monetary or Material Support  
Svyasa University Banglore, Morarji Desai Institute of naturopathy & Yogic sciences, Vadodara 
 
Primary Sponsor  
Name  Swami Vivekananda Yoga University  
Address  19 Eknath Bhavan Gavipuram Circle K.G.Nagar Bangalore Krnataka Bangalore  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Morarji desai Institute of naturopathy Yogic Sciences  Opp- RR park, Anand Nager, Water tank road, Karelibaug,Vadodara,Gujarat-390022 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ripudaman singh  Morarji Desai Institute of Naturopathy & Yogic Sciences  Yoga Hall, Division of Yoga, Morarji Desai college
Vadodara
GUJARAT 
8141092382
2652481623
drripudaman84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Svyasa Banglore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (2) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (3) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group will be continued with their current medicines as per the advice of their physician.  patients will be asked to continue their present treatment and medicines but any changes in dosage and symptoms will be noted timely. 
Intervention  Shuddhi Kriya based Yoga Program.  Yoga class specially focussed on Shuddhi kriyas along with sukshma kriyas, stretching & bending asanas,Pranayama, Relaxation and Meditation. Shuddhi kriyas- Laghu sankhprakshalana,Neti,Vaman Dhauti,kapalbhati etc. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  41.00 Year(s)
Gender  Both 
Details  Those who clinically diagnosed with Allergic rhinitis, based upon symptoms according to criteria proposed in the “International Consensus on Diagnosis and Management of Rhinitis (1994)”: Allergic Rhinitis could be seasonal or perennial, infectious or others.
Those who have typical symptoms of AR including rhinorrhea, sneezing, nasal obstruction for at least 2 previous consecutive years.
 
 
ExclusionCriteria 
Details  Nasal polyp.
Deviated nasal septum which is not suitable for entry of rubber catheter/Sutra.
Rhinitis medicaments.
Those who are under treatment with Systemic corticosteroid for any other disorder.
Patients receiving immunotherapy within the previous 2 years.
Subject with any history of Epistaxis.
CSF rhinorrhea
Hypertension & heart disease, renal disease, hepatic impairments, cancer or other active medical problem
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
TNSS, Anosmia, headache, fatigability and irritability
Changes in the dosage of medication
Biochemical changes- IgE, AEC,ESR
Nasal swab smear test
 
9th week, 25th week  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life Assessment tools -SQI,RQLQ,WPAI: SHP
Clinical Assessment tools-
PNIF,PEFR, 
Before Trial And
two months after commencement of Trail 
 
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   N/A 
Date of First Enrollment (India)   13/10/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

                                                                         Allergic rhinitis is very common nowadays making it difficult for the patients to work in their full efficiency during diseased condition it reduces productivity and quality of life. Even being very prevalent in the society it is mostly underdiagnosed till it do not cause other associated problems. There are numbers of methods of alternative medicine to relieve symptoms yogic management is being one of them. Yoga is more holistic because it has components like Kriyas (cleansing techniques), Asana (physical exercise), Pranayama (breathing exercise) and meditation. We are doing this research to find out if Shuddhi Kriya Based Yoga Program is effective for Allergic Rhinitis patients when done properly on Physical, Biochemical and Psychological profile of patients. Previous intervention studies on allergic rhinitis have been using pharmacological agents and have shown high effect sizes. (> 0.7) [give reference], however, in the present study, we plan to use non-pharmacological means (yoga practices and nasal wash technique) and therefore have fixed a conservative estimate of the effect size of 0.5 and with an alpha of 0.5 and power of 0.8 the sample size in each group is calculated to be 26. And considering 20% dropout, we will recruit 30 in each group so the total sample size would be 30+30= 60 no. of Subjects.

 
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