| CTRI Number |
CTRI/2026/03/105573 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study of Two Ayurvedic Treatments for Allergic Rhinitis |
|
Scientific Title of Study
|
A Comparative Study on Effect of Vyoshadi Churna orally and Katuphaladi Churna Pradhaman Nasya In The Management Of Kaphaja Pratishyaya With Special Reference To Allergic Rhinitis. |
| 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 Shubham H Maraskolhe |
| Designation |
PG Scholar |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya, OPD No. 16, Shalakyatantra Department, Shivaji nagar, Arni Road, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
8446996857 |
| Fax |
|
| Email |
smaraskolhe22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayantkumar V Wagh |
| Designation |
Associate Professor |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya, OPD No. 16, Shalakyatantra Department, Shivaji nagar, Arni Road, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9420371870 |
| Fax |
|
| Email |
jayantkumarwagh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayantkumar V Wagh |
| Designation |
Associate Professor |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya, OPD No. 16, Shalakyatantra Department, Shivaji nagar, Arni Road, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9420371870 |
| Fax |
|
| Email |
jayantkumarwagh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L K Ayurved Rugnalaya Yavatmal
Shivajinagar Arni Road Yavatmal Maharashtra India 445001 |
|
|
Primary Sponsor
|
| Name |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya And L.K. Ayurved Rugnalaya, OPD No. 16, Shalakyatantra Department, Shivaji nagar, Arni Road, Yavatmal,445001,Maharashtra, 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 Shubham H Maraskolhe |
Lakshmanrao Kalaspurkar Ayurved Rugnalaya, Yavatmal |
OPD No. 16, Shalakyatantra Department L.K. Ayurved Rugnalaya, Shivaji Nagar, Arni Road, Yavatmal, Maharashtra, India 445001
Yavatmal
MAHARASHTRA |
8446996857
smaraskolhe22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee DMM Ayueved Mahavidyalaya Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pradhamanam/ dhmApanam, प्रधमनम्/ ध्मापनम् | (Procedure Reference: Ashtang hridaya, Procedure details: Purvakarma
1. The Purvakarma of Nasya was performed in a place having sufficient
light, devoid of direct flow of wind & dust.
2. Patient was asked to lie down comfortably in supine position on a table
and Sthanika mukha abhyanga was administered with Tila staila.
3. Both the eyes close with wet cotton swab.
Pradhana Karma
1. After completion of Purva Karma, patient was made to lie down
with head tilting position at 45-degree angle from edge of the table.
2. Patient was advised to relax with closing the eyes.
3. Required dose of Katuphaladi Churna was kept in the one end
(which smaller in diameter in comparison to other end) was
cautiously inserted into one nostril of patient and blown from end
by physician through mouth.
4. The same procedure was repeated in another nostril.
Pashchat Karma
1. After performing the Nasya Karma, patient was allowed to relax in
supine position.
2. Again, Mrudu Abhyanga and Sveda was done around face, nose, head,
neck and chin.
3. Patient was advised to spit out the nasal secretion reaching the throat.
Dhoomapana was given and Sukoshna Jala for Kavala.
4. After this, the patient was instructed not to take cold food or water and
to avoid exposure to wind, headbath, dust and all the regimens which
has to be followed at the time of NasyaKarma. )
(1) Medicine Name: Katuphaladi Churna, Reference: Charak chikitsasthan, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Churna, Reference: Chakardatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Jaggery), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as per diagnostic criteria.
2. Patients from Age group of 20 to 60 years irrespective of gender, religion, occupation having signs and symptoms of Kaphaj Pratishyaya.
3. Patients willing for Treatment. |
|
| ExclusionCriteria |
| Details |
a. Patients with Known case of systemic Illness like Hypertension,Diabetes mellitus HIV,HBsAg.
b. Patients Ayogya for Nasya Karma.
c. Patients not willing for treatment. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Signs and symptoms will be evaluated with the TNSS (Total Nasal Symptoms
Score)
It is widely used clinical tool for assessing the severity of allergic rhinitis
symptoms.
TNSS is typically based on a patients self-assessment of four key nasal
symptoms
A. Nasal congestion
B. Nasal itching
C. Sneezing
D. Rhinorrhea (runny nose) |
0th, 3rd, 5th, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.CBC, ESR
2.By History taking
3.By Questioning
4.By Local Examination |
0TH, 7TH Day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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
|
Allergic rhinitis is a common chronic inflammatory condition of the nasal mucosa characterized by sneezing, nasal discharge, nasal obstruction, and itching. In Ayurveda, it can be correlated with Kaphaja Pratishyaya, which predominantly involves vitiation of Kapha dosha.
The present study is designed to evaluate and compare the therapeutic efficacy of Vyoshadi Churna administered orally and Katuphaladi Churna Pradhaman Nasya (intranasal administration) in the management of Kaphaja Pratishyaya with special reference to allergic rhinitis.
Participants diagnosed with allergic rhinitis fulfilling the inclusion criteria will be randomly allocated into two groups. Group A will receive Vyoshadi Churna orally, and Group B will receive Katuphaladi Churna as Pradhaman Nasya for a specified treatment duration. The assessment will be carried out based on subjective parameters such as sneezing, nasal discharge, nasal obstruction, and itching, along with objective parameters wherever applicable.
The study aims to compare the effectiveness of both interventions and establish a safe and effective Ayurvedic management protocol for allergic rhinitis. |