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CTRI Number  CTRI/2025/03/082451 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 16/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To asses the effect of powder of vidanga used as nasya for headache caused due to sinusitis 
Scientific Title of Study   To Compare The Efficacy of Vidanga Churna Pradhamana Nasya With Vidanga Taila Nasya In Kaphaja Shirashula-Chronic Rhino Sinusitis-An Open Label Double Arm Randomised Clinical 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  Dr Navya R 
Designation  PG Scholar 
Affiliation  Shri Dharmasthala Manjunateshwara Institute of Ayurveda and Hospital Bangalore 
Address  N0 5/2 Geetanjali Apartment flat no 101 1st cross MRCR vijayanagar Bangalore 40

Bangalore
KARNATAKA
560040
India 
Phone  9611502333  
Fax    
Email  ayushveda2019@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharanprasad Kolliyavar 
Designation  Associate Professor 
Affiliation  Shri Dharmasthala Manjunateshwara Institute of Ayurveda and Hospital Bangalore 
Address  Shri Dharmasthala manjunatheshwara institute of ayurveda and hospital bengaluru

Bangalore
KARNATAKA
560070
India 
Phone  9844897784  
Fax    
Email  drsharanprasad.k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navya R 
Designation  PG Scholar 
Affiliation  Shri Dharmasthala Manjunateshwara Institute of Ayurveda and Hospital Bangalore 
Address  No 5/2 Geetanjali Apartment flat no 101 ,1st cross, MRCR vijayanagar Bangalore 40

Bangalore
KARNATAKA
560040
India 
Phone  9611502333  
Fax    
Email  ayushveda2019@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjusnateshwara institute of ayurveda and hospital bangalore 560070 Karnataka India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Navya R  Shri Dharmasthala Manjunateshwara Institute of Ayurveda and Hospital Bengaluru  Department of Shalakya Tantra OPD NO 11 10 16 SH17, Anchepalya, Bengaluru, Challegatta, Karnataka 560074
Bangalore
KARNATAKA 
9611502333

ayushveda2019@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Shri Dharmasthala manjunateshwara institute of ayurveda and hospital bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:3||Administration. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA, (2) ICD-10 Condition:3||Administration. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: vidanga churna, Reference: charaka , Route: Nasal, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: vidanga taila, Reference: sushrutha samhita, Route: Nasal, Dosage Form: Taila, Dose: 0.4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients presenting with lakshanas kaphaja shirashula (chronic rhinosinusitis)
2. Age 20-50 years
3. Patients of either sex
4. Patients fit for Nasya Karma
5. Chronicity less than 1 year
 
 
ExclusionCriteria 
Details  1. Patients suffering with other types of Shiroroga
2. Patients with complications of chronic sinusitis such as orbital cellulitis,osteomyelitis
3. Patients with nasal polyps
4. Cases of inverted papilloma
5. Malignancy
6. Congenital anomalies of nose and sinus
7. Patients with gross Deviated Nasal Septum
8. Patients unfit for nasya karma
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• To assess the effect of Vidanga Churna Pradhamana nasya in relieving the complaints of Kaphaja Shira Shula (Chronic Rhino Sinusitis) on the basis of subjective and objective parameters.  7th day 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
• Decrease in score in SNOT 22 from base score  7th day 15 th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   06/04/2025 
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="6"
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  

 

Sinusitis is a widespread health issue affecting millions of people worldwide. It may be acute or chronic it can result from various causes such as infections, allergies, or structural issues, causing symptoms such as facial pain, headaches, nasal congestion, and difficulty in breathing; these symptoms significantly impact a person’s daily life and can impose a significant economic burden on individuals, by finding treatments which are cost effective, healthcare costs related to sinusitis can be reduced, that include doctor visits, medications, and surgical interventions.  Understanding and developing effective treatments are necessary to alleviate these symptoms and improve the quality of life. Chronic rhino sinusitis is the inflammation of the nasal cavity and Para nasal sinuses in which the symptoms lasts more than 12 weeks Untreated sinusitis causes complications, such as the spread of infection to the nearby structures or the development of chronic inflammation. Studying treatment protocols help prevent these complications and help improve patient outcome which is a crucial aspect of healthcare research.

Chronic rhino sinusitis affects 1 in 8 people in India and about 5 to 15 percent of urban population.

 

Acharya Sushruta has mentioned 11 types of Shiroroga in uttara tantra and Kaphaja Shiroroga is one of them in this condition we find symptoms like kapha upadigdha shira  kapha upadigdha gala, guruta, shuna akshi kuta and vadana, Acharya vaghbatta  also explains kaphaja shirashula as one among the ten shirorogas presenting with manda ruk, shiro guruta, which resemble the symptoms of chronic rhino sinusitis.

 

The available treatments for chronic rhino sinusitis include nasal steroid drops/ sprays, antibiotics, analgesics, anti-histamines, decongestants and surgical interventions which provide temporary symptomatic relief with a high chance of reoccurrence and are economically draining.

In Ayurveda the line of treatment for kaphaja shirashula includes shirovirechana, teekshna vamana, pradhamana , gandusha dharana of which nasya is one of the prime treatment modality as it is rightly pointed nasa hi shiraso dwaram” nose is the gateway of the shiras  

Among these different set of treatments, a research study on Vidanga Taila has been proved to be effective in treating Chronic Sinusitis.

According to Acharya Charaka Pradhamana with teekshna dravyas (Shirovirechana Dravyas)is mentioned as one of the important treatment modality for Kaphaja Shirashula, Vidanga is one among the shirovirechana dravyas it is ruksha and teekshna in guna it is kaphavatahara, krimigna and vishagna these properties help in doing the kaphavilayana thus efforts are put forth to Compare The Efficacy of Vidanga Taila Nasya with Vidanga Churna Pradhamana Nasya In Kaphaja Shirashula.

 
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