| CTRI Number |
CTRI/2025/07/091151 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Compairing the benefits of Pippalyasava and Nimbasava nasya for treating long term sinus problems |
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the effect of Pippalyasava and nimbasava nasya in chronic rhinosinusitis. |
| 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 Aswathi I |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda College Pariyaram Kannur |
| Address |
Department of salakyatantra
OPD number 8
Government Ayurveda college Pariyaram
Kannur
Pariyaram po
670503
Kannur
KERALA
670503
India |
| Phone |
9048413293 |
| Fax |
|
| Email |
aswathiprabha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muhammed Nissam C P |
| Designation |
Assistant professor |
| Affiliation |
Govt.Ayurveda College Pariyaram Kannur |
| Address |
Department of salakyatantra
OPD number 8
Govt.Ayurveda college Pariyaram
Kannur
Pariyaram po
670503
Kannur
KERALA
670503
India |
| Phone |
9744047537 |
| Fax |
|
| Email |
dr.nissam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muhammed Nissam C P |
| Designation |
Assistant professor |
| Affiliation |
Govt.Ayurveda College Pariyaram Kannur |
| Address |
Department of salakyatantra
OPD number 8
Govt.Ayurveda college Pariyaram
Kannur
Pariyaram po
670503
Kannur
KERALA
670503
India |
| Phone |
9744047537 |
| Fax |
|
| Email |
dr.nissam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Pariyaram ,Kannur
pariyaram po
670503 pin
kerala
India |
|
|
Primary Sponsor
|
| Name |
Dr Aswathi I |
| Address |
Govt.Ayrveda college Pariyaram Kannur
Pariyaram po
670503 |
| 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 |
| Dr Aswathi I |
Govt.Ayurveda College Hospital Pariyaram Kannur |
Fepartment of salakyatanra
OPD number 8
Government Ayurveda College Kannur
Pariyaram po
670503
Kannur
KERALA |
9048413293
aswathiprabha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Government Ayurveda College Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: NASAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridayam, Procedure details: Measured dose of medicine, taken in a gokarna is made lukewarm by placing it over
boiled water and poured into either nostril in a single stream.
• Immediately after the instillation of medicine, mild massage is done over sole, palm,
shoulder, neck, forehead, face and ears .
• Subject is asked to inhale the medicine with moderate force and spit it through mouth
turning head to either side alternatively without rising from the cot)
(1) Medicine Name: Pippalyasavam, Reference: Sharangadhara Samhitha, Route: Nasal, Dosage Form: Asava, Dose: 0.4(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Nimbasava, Reference: Ashtanga Hridayam, Route: Nasal, Dosage Form: Asava, Dose: 0.4(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed with chronic rhinosinusitis within 1 month by X-rays
2. Chronicity greater than 12 weeks
3. Participants with 2 or more signs and symptoms such as nasal obstruction, mucopurulent discharge, facial pain, decreased sense of smell
4. Subjects who are willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Subjects with clinical features of any complication of Chronic rhinosinusitis.
2. Subjects who are advised for surgical procedure.
3. Subjects with hypertension or diabetes mellitus.
4. Subjects with any chronic debilitating infectious diseases.
5. Subjects with nasal polyp.
6. Subjects with any evidence of nasal tumors.
7. Subjects with a history of nasal bleeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nasal Signs and Symptoms Score
VAS Scale |
0th, 6th and 15th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
12/11/2025 |
| 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 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 is an inflammatory condition affecting the paranasal sinuses that lasts
for more than 12 weeks. The clinical features include nasal discharge, nasal obstruction,
disturbance of smell and headache.
In Ayurveda, this condition can be correlated with Dushtapratishyaya based on its
symptoms. As Dushtapratishyaya is an Urdhva jatrugata vyadhi, nasya is considered as the
best treatment option. Asava is indicated for shodhana nasya in Ayurvedic classics. The effect
of Nimbasava and Shirovirechana gana dravya siddha asava nasya in this conditions has been
proven in previous studies. So, this study is planned to compare the effect of Pippalyasava and
Nimbasava nasya in chronic rhinosinusitis.
A comparative clinical trial with 38 participants satisfying the inclusion criteria will be selected
from the outpatient department of Shalakyatantra, Government Ayurveda College Hospital,
Kannur. Group A and Group B will be administered Pippalyasava and Nimbasava nasya
respectively. The effect of both the interventions will be assessed by the improvement in Nasal
Signs and Symptoms Score and Visual Analogue Scale (VAS Scale) evaluated from the
baseline, on the 6th day and follow-up on 15th day. Result will be statistically analysed
after the study. |