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CTRI Number  CTRI/2023/05/052824 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Shigrubeeja taila (Oil prepared by Seeds of Moringa)nasya in Kaphaja Shirashoola (Chronic Sinusitis) 
Scientific Title of Study   A randomized open labelled controlled clinical study to evaluate the efficacy of Shigrubeeja Taila Nasya in the management of Kaphaja Shirashoola with special reference to Chronic sinusitis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhilash K N 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 305 Department of PG studies in Shalakya tantra, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM, Kanakapura main road Udayapura post 560082 Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9686382920  
Fax    
Email  abhilash2ayurveda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geethakumari B 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 305 Department of PG studies in Shalakya tantra, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM, Kanakapura main road Udayapura post 560082 Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9480056218  
Fax    
Email  ayurgeeta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geethakumari B 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital 
Address  Room no 305 Department of PG studies in Shalakya tantra, Sri Sri College of Ayurvedic Science and Research Hospital 21st KM, Kanakapura main road Udayapura post 560082 Bangalore.

Bangalore
KARNATAKA
560082
India 
Phone  9480056218  
Fax    
Email  ayurgeeta@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Abhilash K N 
Address  Sri Sri College of Ayurvedic Science and research Hospital 21st KM, Kanakapura main road, Udayapura post, Bengaluru 560082 
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 
Dr Abhilash K N  SRI SRI COLLEGE OF AYURVEDA SCIENCE AND RESEARCH HOSPITAL  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082
Bangalore
KARNATAKA 		 9686382920

abhilash2ayurveda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  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. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA, (2) ICD-10 Condition:J329||Chronic sinusitis, unspecified. 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: Subjects diagnosed with Kaphajashirashoola will be selected and in empty stomach Nasya procedure for continuous 7 days planned. As poorvakurma, mukhabhyanga and mild swedana will be done. As pradhana karma, 8 drops of selected medicine will be instilled in each nostril for continuous 7 days done. As paschat karma - Haridradivarti dhoomapana will be done.)
(1) Medicine Name: Shigru Beeja , Reference: Astanga Hrudaya, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Astanga Hrudaya, Procedure details: Subjects diagnosed with Kaphajashirashoola will be selected and in empty stomach Nasya procedure for continuous 7 days planned. As poorvakurma, mukhabhyanga and mild swedana will be done. As pradhana karma, 8 drops of selected medicine will be instilled in each nostril for continuous 7 days done. As paschat karma - Haridradivarti dhoomapana will be done.)
(1) Medicine Name: Vidanga, Reference: Astanga Hrudaya, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects aged between 21 to 60 years will be selected irrespective of gender,
occupation, religion and socio-economic status.
2. Subjects fulfilling diagnostic criteria.
3. Subjects willing to sign the informed consent.
4. Subjects fit for Nasya Karma. 
 
ExclusionCriteria 
Details  1. Subjects suffering with other types of Shiroroga.
2. Subjects diagnosed with uncontrolled systemic and neurological illness.
3. Subjects diagnosed with complications of sinusitis such as Orbital cellulitis
and Osteomyelitis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in following Symptoms
1. Shirobhitaapa (Tenderness in head)
2. Shirashoola (Headache)
3. Shiro Gurutva (Heaviness of head)
4. Nasasrava (Nasal discharge)
5. Pratistabdham (Nasal obstruction)
6. Shoonakshikuta Vadanam (Puffiness of face). 		 -0th day
-7th day
-21st day
-35th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in X-Ray PNS  -0th day
-35th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/06/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Kaphaja Shirashoola is one in which there will be Shirashoola due to accumulation of vitiated Kapha in Shirah Pradesha. Sinus headache or headache due to Sinusitis is caused by mucous build up as a result of inflammation and pressure within sinus during sinus infection. The pain from sinus headaches is usually more of a dull pain and usually worsen at nights. 
Nasya Karma is considered as a prime treatment modality in all types of Shiroroga and also in Kaphaja Shirashoola. Vidanga Taila Nasya and Shigru Beeja Taila Nasya is indicated in the management of Kaphaja Shirashoola. Hence, this work is intended to ascertain the efficacy of the Shigru Beeja Taila Nasya and Vidanga Taila Nasya in Kaphaja Shirashoola with special reference to Chronic Sinusitis.
 
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