| CTRI Number |
CTRI/2026/01/101330 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To the study the effect of a herbal nasal spray along with internal medicine in managing the symptoms of Allergic rhinitis |
|
Scientific Title of Study
|
Efficacy of Parnayavani arkam nasal spray as an add-on to Haridra Khandam in the management of Allergic Rhinitis- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sethulakshmi A M |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam Ayurveda College |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College, Thaikkattussery, Ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
8289983509 |
| Fax |
|
| Email |
sethulakshmi31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T C Marikutty |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam Ayurveda College |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College, Thaikkattussery, Ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
9447829212 |
| Fax |
|
| Email |
drmarikuttytc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T C Marikutty |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam Ayurveda College |
| Address |
Department of Kayachikitsa
Vaidyaratnam Ayurveda College, Thaikkattussery, Ollur, Thrissur
Thrissur
KERALA
680306
India |
| Phone |
9447829212 |
| Fax |
|
| Email |
drmarikuttytc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam Oushadhasala
Thaikkattussery P O, Ollur
Thrissur,Kerala,India
680301 |
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam Ayurveda College |
| Address |
Vaidyaratnam Ayurveda College
Thaikkattussery, Ollur, Thrissur,Kerala,India
680306 |
| Type of Sponsor |
Other [Aided college] |
|
|
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 |
| Sethulakshmi A M |
Vaidyaratnam Ayurveda College Hospital |
Department of Kayachikitsa
OP NO 1
Vaidyaratnam Ayurveda College Thaikkattussery, Ollur, Thrissur
680301
Thrissur
KERALA |
8289983509
sethulakshmi31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidyaratnam Ayurveda College |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Parnayavani Arkam, Reference: NA, Route: Nasal, Dosage Form: Arka, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: NA, Route: -, Dosage Form: Arka, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra Khandam, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants in the age group 18 to 50 irrespective of gender with Total Nasal
Symptom Score greater than 4.
2. Symptoms present for more than 2 days a week.
3. Elevated IgE levels greater than 100 IU PER ML |
|
| ExclusionCriteria |
| Details |
1. Previous history of Bronchial Asthma, Tuberculosis and any other lungs related
disease.
2. Participants with chronic sinusitis.
3. Cases requiring surgical treatment such as nasal polyp.
4. Participants with Hyper immunoglobin E syndrome
5. Participants who are currently under medications like antihistamines, corticosteroids
etc.
6. Pregnant women and Lactating Mothers.
7. Participants having completed any other trial within the past 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Total Nasal Symptom Score
2.Rhino conjunctivitis Quality of Life Questionnaire
Objective parameters
3.Total Lymphocyte Count
4.Erythrocyte sedimentation Rate
5.Absolute Eosinophil Count
6.Serum IgE |
Day 0,Day 7,Day 16,Day 31 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rhino conjunctivitis Quality of Life Questionnaire |
Day 0, Day 16, Day 31 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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 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
|
A Randomized Controlled Trial is planned to study the add on effect of Parnayavani arkam given as nasal spray along with Haridra Khandam in the management of Allergic rhinitis. Allergic rhinitis is a condition which involves upper respiratory tract which is characterized
by watery nasal discharge, nasal obstruction, sneezing, itching in the nose, associated with
ocular symptoms such as itching, watering, redness and swelling. Haridra khandam
is clinically proven for it’s efficacy in reducing symptoms of Allergic rhinitis. In this
study a nasal spray made of Arka prepared from Parnayavani is studied for it’s added benefit
in symptomatic management of Allergic rhinitis and improving the quality of life. . Rhinoconjunctivitis Quality Of Life Questionnaire
is used as a tool to assess the Quality of life before and after treatment. |