| CTRI Number |
CTRI/2025/06/088773 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Effect of ayurveda treatment protocol using Nasal Oil Therapy and Herbal Drink in long term sinus problem |
|
Scientific Title of Study
|
Effectiveness Of Shirovirechana Gana Taila Nasya and Mundopakulyadi Kashaya Pana In The Management Of Chronic Rhino-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 |
Mayuri J S |
| Designation |
PG Scholar Department Of Salakya Tantra |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
PG scholar
Department of salakya tantra
OPD NO 5
Government ayurveda college
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
09496959145 |
| Fax |
|
| Email |
karthikaunnimayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bijumon O C |
| Designation |
Associate professor, Department Of Salakya Tantra |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of salakya tantra
Government ayurveda college
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
09496959145 |
| Fax |
|
| Email |
drocbijumon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayuri J S |
| Designation |
PG Scholar Department Of Salakya Tantra |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
PG scholar
Department of salakya tantra
OPD NO 5
Government ayurveda college
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
09496959145 |
| Fax |
|
| Email |
karthikaunnimayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital
Thiruvananthapuram
pin 695001
kerala |
|
|
Primary Sponsor
|
| Name |
MAYURI J S |
| Address |
Karthika
Venga P O
Sasthamcotta
Kollam
Pin 690521 |
| 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 |
| Mayuri J S |
Government Ayurveda College Hospital Thiruvananthapuram |
PG scholar
Department of salakya tantra
OPD NO 5
Government ayurveda college Hospital, MG road, Thiruvananthapuram
Pin 695001
Thiruvananthapuram
KERALA |
9496959145
karthikaunnimayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IES) Govt ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: DUSHTAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mundopakulyadi Kashayam, Reference: Arogya Raksha Kalpa Drumam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 36 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridayam Sutrasthanam, Procedure details: 10 ml of shirovirechana gana taila will be taken and made lukewarm.While instilling the medicine, physician has to stand at the back of the patient, then raise the tip of the nose with middle finger of left hand and close the left nostril with ring finger of the same hand.Then 2.5 ml of lukewarm medicine should be continuously poured into the right nostril with right hand.Then 2.5 ml has to be instilled into left nostril after closing the right nostril.Ask the participant to inhale slowly and spit out the sputum, which causes proper expulsion of medicine.
20
Care should be taken that no trace of medicine is left out.Before administrating the remaining medicine, Abhyanga and Swedana will be repeated.
Again 2.5 ml of shirovirechan gana taila will be instilled in each nostril in the same manner
alternatively, and same procedure will be followed.)
(1) Medicine Name: Shirovirechana Gana Tailam, Reference: Ashtanga Hridayam, Route: Nasal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Clinically Diagnosed Cases Of Chronic Rhino-Sinusitis With Symptoms Headache, Nasal
Obstruction, Nasal or Postnasal Purulent Discharge, Loss Of Smell, Facial Pain and Pressure.
b) Participants Between Age Group Of 18-50 Years irrespective of gender, religion and
socioeconomic status.
c) Participants who are suitable for nasya. |
|
| ExclusionCriteria |
| Details |
a) Diagnosed Cases Of Pan sinusitis, Middle Ear Infection.
b) Participants Diagnosed With Any Other Forms Of Headache Such As Migraine, Tension Headache And
Trigeminal Neuralgia.
c) Pregnant And Lactating Mothers
d) Those Contraindicated For Nasya.
e) Diagnosed Cases Of TB On Medication.
f) Participants With History Of Multiple Episodes Of Epistaxis, Disorders Of Blood Coagulation And
Malignancy.
g) Participants With History Of Major Brain Surgery.
h) Participants With History Of Traumatic Injury Of Brain And Diagnosed Cases Of Cerebro-Vascular Accidents.
i) Participants With History Of Status Asthmaticus
j) Participants Diagnosed With Nasal Polyp And With Severely Neviated Nasal Septum. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Visual Analogue Scale (VAS) Score In Headache
Change In Sino Nasal Outcome Test (SNOT 22) For, Nasal Obstruction, Nasal or Postnasal Purulent Discharge, Loss Of Smell, Facial Pain And Pressure.
|
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in score values of X-ray PNS graded by using Lund Mackay Scale
0 No haziess
1 mild haziness
2 complete haziness |
X-ray will be taken before treatment (0th day) & on 22 nd day. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of nasal and paranasal sinus mucosa,
where symptomatology has continued beyond 12 weeks. It is a multifactorial disease caused by infection
or inflammatory process. Structural deformities obstructing sinus ostia, smoking, snuff dipping, prolonged
intra nasal medications, primary and acquired immune deficiency, primary ciliary dyskinesia, cystic
fibrosis are the predisposing factors of chronic rhinosinusitis.1 The infection results in mucosal swelling
with obstruction of the sinus ostia. Due to inflammation mucous that become more viscous.
These changes in the nasal-sinus environment leads to mucostasis and bacterial colonization.
The cardinal symptoms of chronic rhinosinusitis are headache, nasal obstruction, nasal or postnasal
purulent discharge,facial pain and pressure, disturbance of smell. The clinical presentation of
chronic rhino-sinusitis indicates an excess of kapha-vata dosha in the upper respiratory tract, which shares
similarities with the symptomatology of dushtapratisyaya. In this condition there is increased dosha
vitiation and uttarothara dhatu dushti. Therefore, it is essential to undergo a sodhana therapy to eliminate
the excess dosha. 20 patients within the age group of 18-50 years diagnosed with CRS selected on
the basis of inclusion criteria, attending OPD and IPD of Shalakyatantra, Govt.Ayurveda College,
Thiruvananthapuram will be subjected to Marsha nasya with shirovirechana gana taila for 7 days followed
by mundoupakulyadi Kashaya pana for the next 14 days. Clinical evaluation and investigations will be
done prior to the commencement of intervention, 8th day and 22 th day.Follow up will be done after 2
weeks to access any recurrence of the disease. Results will be statistically analysed after the study by
Kruskal-wallis test. |