FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/05/003709 [Registered on: 31/05/2013] Trial Registered Retrospectively
Last Modified On: 31/05/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Sinusitis treatment with Ayurvedic medicine 
Scientific Title of Study   Effect of Bhringaraj Patra Swarasa in the management of Suryavarta  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K S Sangolli 
Designation  Asst.Prof,Dept of Shalakyatantra 
Affiliation  KLEU Shri BMK Ayurved Medical College 
Address  KLE Ayurved Hospital, Dept of Shalakya tantra (ENT OPD Room No.16) Shahapur, Belgaum
KLEU Shri BMK Ayurved Medical College, Shahapur, Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  09448266969  
Fax  08312424157  
Email  drksskle@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K S Sangolli 
Designation  Asst.Prof,Dept of Shalakyatantra 
Affiliation  KLEU Shri BMK Ayurved Medical College 
Address  KLEU Shri BMK Ayurved Medical College, Shahapur, Belgaum
KLEU Shri BMK Ayurved Medical College, Shahapur, Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  09448266969  
Fax  08312424157  
Email  drksskle@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K S Sangolli 
Designation  Asst.Prof,Dept of Shalakyatantra 
Affiliation  KLEU Shri BMK Ayurved Medical College 
Address  KLEU Shri BMK Ayurved Medical College, Shahapur, Belgaum
KLEU Shri BMK Ayurved Medical College, Shahapur, Belgaum
Belgaum
KARNATAKA
590003
India 
Phone  09448266969  
Fax  08312424157  
Email  drksskle@gmail.com  
 
Source of Monetary or Material Support  
Patients attending both OPD and IPD of Dept of Shalakyatantra KLE Ayurveda hospital, Belgaum. And Exclusive ENT camps organised by KLE Ayurveda hospital  
 
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 K S Sangolli  KLE Ayurvedic Hospital  KLE Ayurvedic Hospital & Research Centre, Shahapur, Belgaum.
Belgaum
KARNATAKA 
0831-2486286
0831-2424157
drksskle@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects, KLE Universitys Shri B. M. Kankanawadi Ayurved Mahavidyalaya, Belgaum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Suryavarta (Frontal Sinusitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  6 drops of fresh juice of Bhringaraja(Eclipta Alba) leaves in each nostril continously for 7-days on early morning with empty stomach.  Freshly prepared 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients fulfilling the diagnostic criteria of Suryavarta (Frontal Sinusitis).
2.Patients in the age group of 15 to 60 years with chronicity less than 3 years.
3. Patients with normal values of Hemoglobin, Total count, Differential count, Erythrocyte Sedimentation Rate and Absolute Eosinophil count were included for the study. 
 
ExclusionCriteria 
Details  1 All chronic vascular headaches
2 Frontal headaches with involvement of inflammation of neighboring structures
3 Headaches with involvement of other intracranial pathology
4 Patient who has undergone any kind of surgical treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduces the headache, nausea, photophobia, Edema of upper eyelid and Nasal Discharge   2-days 
 
Secondary Outcome  
Outcome  TimePoints 
70% of existing symptoms were reduced  7-days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/01/2008 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Suryavarta is a commonest clinical condition among the patients presenting to physicians with headache as a cardinal feature. The symptomatology of which reveals its close resemblance with that of Frontal sinusitis of varied etiology found either with acute or chronic form. According to classics of Ayurveda pathogenesis of Suryavarta is a result of more than one doshas. Charaka opined that Rakta and Vatadoshas are responsible for the manifestation of the disease where as Sushruta described it as Tridoshaja disease and is difficult to cure. Frontal sinusitis affects 14% of total population with peak incidence in the age group between 20 to 30 years and less frequently seen in children.Recurrent attacks and incomplete treatment makes it chronic. It lacks in specific medical treatment and the surgical intervention is not suitable for all.  This instills a need for Ayurvedic management of Suryavarta(Frontal Sinusitis). For the same reason this study was undertaken to evaluate the effect of Nasya (Trans nasal administration) with  fresh juice of  Bhringaraja(Eclipta Alba) leaves in the management of Suryavarta(Frontal Sinusitis). 81 patients of Suryavarta(Frontal Sinusitis) were selected incidentally and administered Nasya with fresh juice of  Bhringaraja(Eclipta Alba) leaves – 8 drops in each nostril for 7 days. To assess the efficacy of treatment, the symptoms of Suryavarta(Frontal Sinusitis) such as Headache, Nausea, Edema of Upper eyelid, Nasal discharge, Photophobia and  Haziness of Sinuses were noted carefully before commencement and after completion of the treatment. All the parameters showed statistically significant results with ‘P’value<0.05.

 
Close