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CTRI Number  CTRI/2024/10/075679 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Pranic Healing as add–on therapy in chronic rhinosinusitis 
Scientific Title of Study   Evaluating the Impact of Pranic Healing as a Complementary Therapy on Physical, Functional, and Emotional Outcomes in Chronic Rhinosinusitis without Nasal Polyp: A Mixed Method Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roopa N 
Designation  Research Associate 
Affiliation  World Pranic Healing Foundation, India -Research Centre 
Address  44, 4th Main Saraswathipuram, Mysuru

Mysore
KARNATAKA
570009
India 
Phone  9886185872  
Fax    
Email  roopacrc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sowmya N Ghosh  
Designation  ENT Specialist  
Affiliation  Darlas Health Care  
Address  Room No3, No 20, New CH 44, 7th, Main, Swimming Pool Rd, Saraswathipuram, Mysuru,

Mysore
KARNATAKA
570009
India 
Phone  9741805003  
Fax    
Email  entsowmya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Srikanth Jois Nagaraja  
Designation  Head of Research  
Affiliation  World Pranic Healing Foundation, India - Research Centre  
Address  44, 4 Main Saraswathipuram Mysuru

Mysore
KARNATAKA
570009
India 
Phone  9901502828  
Fax    
Email  srikanth@pranichealing.co.in  
 
Source of Monetary or Material Support  
World Pranic Healing Foundation, India, Dharsons, 12, First Floor, Hospital Road, Shivajinagar, Bangalore 560001 
 
Primary Sponsor  
Name  World Pranic Healing Foundation India - Research Centre  
Address  44, 4th main, Saraswathipuram, Mysuru 
Type of Sponsor  Other [Trust ] 
 
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 Sowmya N Ghosh   Darla’s Health Care   ENT Consultation room number 3, No. 20, 7th Main, Swimming Pool Road, Saraswathipuram, Mysuru 570009
Mysore
KARNATAKA 		 9741805003

entsowmya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee World Pranic Healing Foundation, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Treatment + Pranic Healing  Oxymetazoline Nasal drops 2-2-2 drops X 5 days T. Amoxicillin with clavulanic acid 625mg, 1-0-1 X 5 days T. Paracetamol+ Chlorpheniramine maleate + pseudoephedrine 500mg+10mg+4mg, 1-0-1 X 5 days Pranic Healing session twice a week for 4 weeks  
Comparator Agent  Conventional Treatment only  Oxymetazoline Nasal drops 2-2-2 drops X 5 days T. Amoxicillin with clavulanic acid 625mg, 1-0-1 X 5 days T. Paracetamol+ Chlorpheniramine maleate + pseudoephedrine 500mg+10mg+4mg, 1-0-1 X 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Those who consent to participate in the study
2. Both male and female subjects aged 18 years to 65 years
3. Those who were diagnosed with chronic rhinosinusitis without nasal polyp with at least two of the symptoms (a) nasal blockage/obstruction/congestion, (b) nasal discharge (anterior or posterior), (c) facial pain or pressure, or (d) reduction or loss of smell.
4. Subjects with moderate to severe symptoms indicated by SNOT -22 scores ranging from 21 -100
 
 
ExclusionCriteria 
Details  Subjects with positive skin prick test indicating atopy
Subjects with abnormal spirometry results
Subjects who require surgical management within 2 months
Subjects with nasal tumors, acute sinusitis, allergic fungal rhinosinusitis, allergic rhinitis
Subjects with uncontrolled diabetes mellitus
Subjects with severe hepatic and renal disease, and other severe medical conditions requiring immediate intervention.
Subjects with skin diseases such as eczema, urticaria, skin rashes
Lund Mackay CT scores more than 14
Subjects who are on corticosteroids
Subjects with a history of epistaxis due to secondary cause
Subjects who are cognitively impaired and unable to provide reliable symptom ratings.
Subjects who are pregnant or lactating.
Subjects who are not willing to participate
Subjects who are participating in any other clinical or interventional study 
 
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 
Change in SNOT -22 scores and Change in Pittsburgh Sleep Quality Index scores   0, 4 Weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Change in SNOT -22 scores   2 weeks and Telephonic follow up 6 weeks 
Improvement in nasal airflow and nasal patency   0, 4 Weeks  
Pranic Healing Experience Questionnaire (PEPQ) – Qualitative narrative  2, 4 weeks and Telephonic follow up 6 weeks 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   04/11/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [research@pranichealing.co.in].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Chronic rhinosinusitis (CRS), is a common condition where the lining of the nose and sinuses gets inflamed, causing symptoms like a blocked nose, face pain, and trouble smelling, which can last for more than 12 weeks. It impacts quality of life (QOL) and sleep. This study aims to evaluate the effect of Pranic healing as a complementary therapy in CRS patients without Nasal Polyp. 
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