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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J320||Chronic maxillary sinusitis. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJAÂ SIROBITAPA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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 | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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. |