| CTRI Number |
CTRI/2025/12/099472 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic nasal treatments using herbal paste, medicated oil drops, and oral tablets to relieve nasal blockage, loss of smell, sneezing, and runny nose in patients with nasal mass. |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFICACY OF CHITRAKA KSHARA PRATISARANA KARAVIRADHYA MARSHA NASYA AND KSHARA GUTIKA IN NASA ARSHA WITH SPECIAL REFERENCE TO NASAL POLYPOSIS A SINGLE ARM STUDY |
| 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 Pradip Adhikari |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur, Rajasthan |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Jaipur
Department Of Shalakya Tantra, Academic Building, 3rd Floor Room Number 305
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8306377669 |
| Fax |
|
| Email |
dradhikari.p08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shamsa Fiaz |
| Designation |
Professor and Head of Department |
| Affiliation |
National Institute of Ayurveda, Jaipur, Rajasthan |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Jaipur
Department of Shalakya tantra, Academic Building, Third Floor Room Number 309
Jaipur
RAJASTHAN
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Shamsa Fiaz |
| Designation |
Professor and Head of Department |
| Affiliation |
National Institute of Ayurveda, Jaipur, Rajasthan |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Jaipur
Department of Shalakya Tantra, Academic Building, Third Floor Room number 309
Jaipur
RAJASTHAN
302002
India
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Amber Road, Jorawarsingh Gate, Jaipur, Rajasthan
302002
India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Amber Road, Jorawarsingh Gate, Jaipur, Rajasthan
302002
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pradip Adhikari |
National Institute of Ayurveda Hospital, Jaipur |
ENT OPD of Department of Shalakya Tantra (Room No 13) and IPD of Department of Shalakya Tantra, Male and Female General Wards, Cottage, Deluxe and Cubicle Wards of NIA Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
8306377669
dradhikari.p08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J330||Polyp of nasal cavity. Ayurveda Condition: NASARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushruta Samhita Sutrasthana 11/11-13, Procedure details: The Kshara Pratisarana procedure begins with Purvakarma by seating the patient with their face turned upward & visualizing the Nasa Arsha mass using a Thudichum speculum. During Pradhanakarma, the prepared Kshara is carefully applied only to the polypoidal mass & allowed to remain in contact for the prescribed time, typically 60–70 seconds. In the Paschatkarma, the Kshara is first wiped away thoroughly with dry cotton, & the area is immediately neutralized by wiping it again with a swab soaked in lemon juice.
dose: 500mg-1gm, duration 100 vaka matra. administered through: nostrils frequency: 1st,7th & 14th day.
Karviradhya Taila Nasya : dose: (6 bindu in each nostrils)0.5ml, administered through: nostrils frequency: 14 days.
Kshara Gutika
Ashtangahrdaya Chikitsa 10/59-60
Dose: 500 mg BID duration 21 Days, Route Orally )
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All diagnosed patients of Nasal Polyps having sign and symptoms of Nasa Arsha like Atyadhik pratishyaya, Kshyavahu, Krichho swasa-uchwasa, Putinasya, Anunasika, etc.
2. Patients aged between 16-60 years.
3. Patients with associated conditions, such as Chronic rhinosinusitis with Nasal Polyposis (CRSwNP).
4. Patients not currently on systemic corticosteroids or immunotherapy in the last 4 weeks.
5. Patients who provide informed consent for the study.
6. Able to comply with follow-ups and study protocols. |
|
| ExclusionCriteria |
| Details |
1. Patient having Sinonasal malignancies (e.g., squamous cell carcinoma, adenocarcinoma), Olfactory neuroblastoma.
2. Patients who have undergone recent nasal surgery within a span of one month.
3. Patient using systemic corticosteroids.
4. Patients with uncontrolled comorbidities like Hypertension , Diabetes, Bronchial Asthma etc.
5. Patient unfit for Nasya and Kshara Pratisarana.
6. Patient who has been already in any kind of experimental drug study.
7. Patients with cognitive impairment, non-compliance, or inability to provide informed consent.
8. Systemic illness, acute URTI, fungal rhinosinusitis etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms as measured by the Sino-Nasal Outcome Test (SNOT-22) score. |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in polyp size, assessed through the Endoscopic Nasal Polyp Score (NPS) |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 2 |
|
Date of First Enrollment (India)
|
18/08/2026 |
| 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
|
This single-arm clinical study evaluates an integrated Ayurvedic protocol for Nasal Polyposis correlated with Nasa Arsha in Ayurveda It assesses the efficacy of Chitraka Kshara Pratisarana Karviradhya Taila Marsha Nasya and oral Kshara Gutika given along with conservative treatment over 21 days with followup for 2 months The aim is to offer a cost effective minimally invasive alternative to conventional surgery and systemic drugs targeting both local polyp reduction and associated chronic rhinosinusitis with a focus on lowering recurrence and improving patient satisfaction |