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CTRI Number  CTRI/2023/07/055618 [Registered on: 24/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ayurvedic Management Of Maxillary Sinusitis 
Scientific Title of Study   A Comparative Study To Evaluate The Efficacy Of Shuntividangadi Grita Nasya And Vidanga Taila Nasya In The Kaphaja Shirashoola With Special Referance to Maxillary Sinusitis. 
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 K RAKSHA J UDUPA 
Designation  PG SCHOLAR 
Affiliation  Government Ayurveda Medical College, Bengaluru 
Address  Department Of PG Studies In Shalakya Tantra,Shalakya Tantra OPD,Room NO.11,Government Ayurveda Medical College,Dhanvantari Road,Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  7483453260  
Fax    
Email  rakshajudupa97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rathi S 
Designation  Professor 
Affiliation  Government Ayurveda Medical College, Bengaluru 
Address  Department Of PG Studies In Shalakya Tantra,Shalakya Tantra OPD,Room NO.11,Government Ayurveda Medical College,Dhanvantari Road,Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  8970779550  
Fax    
Email  drrathi.s@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Raksha J Udupa 
Designation  Pg Scholar 
Affiliation  Government Ayurveda Medical College, Bengaluru 
Address  Department Of PG Studies In Shalakya Tantra,Shalakya Tantra OPD,Room NO.11,Government Ayurveda Medical College,Dhanvantari Road,Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  7483453260  
Fax    
Email  rakshajudupa97@gmail.com  
 
Source of Monetary or Material Support  
Dr K Raksha J Udupa, Sri Jayachamarajendra Government Ayurveda And Unani Hospital,Government Ayurveda Medical College Campus, Majestic Bengaluru. 
 
Primary Sponsor  
Name  Dr K Raksha J Udupa 
Address  Dhanwantari,Near Ganesh Hollow Block,Ampar Post,Kundapura Taluk,Udupi District,Karnataka-576211  
Type of Sponsor  Other [SELF] 
 
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 
K RAKSHA J UDUPA  Government Ayurveda Medical College And Hospital Bengaluru  Department Of PG Studies In Shalakya Tantra,Shalakya Tantra OPD,Room NO.11,Government Ayurveda Medical College,Dhanvantari Road,Bengaluru-560009
Bangalore
KARNATAKA 
7483453260

rakshajudupa97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Ayurveda Medical College, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J320||Chronic maxillary sinusitis. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: astanga hrudaya, Procedure details: Patient asked to lie down in a supine position, with head slightly hanging down, & the legs slightly raised. Nasya is administered to both nostrils, daily in the morning in empty stomach with specified dose in each nostril for 7 Days. )
(1) Medicine Name: Shunti vidangadi grita, Reference: Gadanigraha, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Astanga Hrudaya, Procedure details: Patient asked to lie down in a supine position, with head slightly hanging down, & the legs slightly raised. Sneha Nasya is administered to both nostrils, daily in the morning in empty stomach with dose of specified bindus in each nostril for 7 Days. )
(1) Medicine Name: Vidanga Taila, Reference: Astanga Sangraha, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Kaphaja sirashoola Lakshana are observed and
included.
2.Patient belonging to the age group of 18-60
years.
3.Patient are selected irrespective of sex,
occupation religion, socio-economic status etc.
4.Those who are eligible for Nasya karma.
5.Patient with X-ray showing haziness in
Maxillary Sinus are included.
 
 
ExclusionCriteria 
Details  1.Patients associated with other systemic illness.
2..Patients with complication of maxillary
sinusitis.
3.Patients suffering from headache which is caused
due to migrane/tension headach.
4.Patients with contraindications of Nasyakarma
were excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
X-ray water’s view  58 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Headache
2.Heaviness of head
3.Nasal discharge
4.Foul smell in the breath
5.Nasal obstruction
6.Puffiness of face
 
58 days 
 
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   Phase 3 
Date of First Enrollment (India)   28/07/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

NEED FOR THE STUDY

Shiras occupying the prime place in human body has to be protected by all means, as it one among dasha pranayatanas.Kaphaja shira shoola is one among types of shirarogas explained Acharya Sushrutha, characterized by phlegm in throat and face, heaviness in the head, oedema of face and eyelids.

Most of the clinical features are correlated with signs and symptoms of maxillary sinusitis, this condition is becoming more significant in population because of few nidanas such as Rajo-Dhoomasevana(atmospheric pollutants), Purovatasevana(exposure to wind currents), ambukrida (swimming) sheeta, madhura, guru snigdha ahara.

Kaphaja shira shoola features include mild/modest headache and heaviness of head. The headache persists throughout the day, and it may increase at night. This condition is commonly associated with nasal discharge, nasal obstruction, and postnasal discharge.Sinusitis affects the mucosa of nose and para nasal sinus affecting approximately 15% population in India. It is seen that increased air pollution and exposure to cold and flu have caused an increase in this condition.Over 85% of people with cold inflamed sinus. These inflammations are typically brief & mild. Only between 0.5% and 5% people with cold develop true sinusitis. Maxillary sinusitis are most common sites.Conservative treatment is indicated for Maxillary Sinusitis like Antibiotics, nasal decongestant drops, steam inhalation, analgesics.

In this scenario, where there is no effective cure for Sinusitis in modern medicine, Ayurvedic line of management may be beneficial. Acharya Sushrutha has mentioned that the patient suffering from kaphaja shira shoola gets relived from the symptoms by kaphahara, teekshna nasya. Nasya karma is easy to administer, cost effective, easily acceptable by patients and can be done at OPD level. Considering the above factors this study was taken up.So Shuntividangadi Grita is used for Nasya as drugs used in this formulation has Kaphahara property.

HYPOTHESIS:

1.   1.  Null hypothesis H0 – shuntividangadi grita Nasya and vidanga taila Nasya is not having any effect on kaphaja shirashoola.

     2.Alternative hypothesis H1- shunti vidangadi griita nasya is having better effect than vidanga taila Nasya in reducing kaphaja shirashoola.

3. 3. Alternate hypothesis H2: vidanga taila nasya is having better effect than shunti vidanga grita Nasya in reducing kaphaja shirashoola.

   4. Alternate hypothesis H3: shuntividangadi grita nasya is having equal effect in reducing kaphaja shirashoola compared to vidanga taila nasya.

 
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