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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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. |