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
|
|
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
|
|
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. |