| CTRI Number |
CTRI/2025/05/086243 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Guda-Ardrak Nasya in Vataja Pratishyaya Allergic Rhinitis A Randomized Controlled Clinical Trial |
|
Scientific Title of Study
|
Effect of Gudaardrak nasya in the Management of Vataja Pratishyaya with special reference to Allergic Rhinitis A Randomised Controlled Clinical 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 |
Dr Adeeb A |
| Designation |
Assistant Professor |
| Affiliation |
KAHERs SBM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs SBM Kankanawadi Ayurveda Hospital Department of Shalakyatantra OPD number 26 and 27 Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
09535861139 |
| Fax |
|
| Email |
dradeeb1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita S Angadi |
| Designation |
Professor HOD |
| Affiliation |
KAHERs SBM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs SBM Kankanawadi Ayurveda Hospital Department of Shalakyatantra OPD number 26 and 27 Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
74111213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita S Angadi |
| Designation |
Professor HOD |
| Affiliation |
KAHERs SBM Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs SBM Kankanawadi Ayurveda Hospital Department of Shalakyatantra OPD number 26 and 27 Shahapur Belagavi
KARNATAKA
590003
India |
| Phone |
74111213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Adeeb A |
| Address |
KAHERs SBM Kankanawadi Ayurveda Mahavidyalaya shahapur Belagavi 590003 Karnataka India |
| Type of Sponsor |
Other [PhD Thesis] |
|
|
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 Adeeb A |
KAHERs SBM Kankanawadi Ayurveda Hospital |
KAHERs SBM Kankanawadi Ayurveda Hospital Department of Shalakyatantra OPD number 26 and 27 Shahapur Belagavi
Belgaum
KARNATAKA |
09535861139
dradeeb1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethics committee |
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 | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Prof K R Srikantha Murthy Ashtanga Hridaya Volue no 2 Edition 2021 Chowkamba Krishnadas Academy Shwasa chikitsa shloka num 47 pg no 252 , Procedure details: Gudaardrak Nasya for 14 days (two sittings with gap of 7days))
(1) Medicine Name: Gudardraka, Reference: Prof K R Srikantha Murthy Ashtanga Hridaya Volue no 2 Edition 2021 Chowkamba Krishnadas Academy Shwasa chikitsa shloka num 47 pg no 252 , Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 6(drops), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudardraka, Reference: R vidyanath k nishteshwar chakradatta chikitsa sangraha of chakrapani chaukambha prakashan first edition chapt 39 shodha adhyaya pn 296, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gudaardraka, Reference: R vidyanath k nishteshwar chakradatta chikitsa sangraha of chakrapani chaukambha prakashan first edition chapt 39 shodha adhyaya pn 296, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Rajeev kumar rai Vangasena Samhita chikitsa sangraha nasaroga chikitsa pgno 597, Procedure details: Rasanjanadi Taila Nasya for 14 days (two sittings with gap of 7 days) )
(1) Medicine Name: Rasanjanadi taila, Reference: Rajeev kumar rai Vangasena Samhita chikitsa sangraha nasaroga chikitsa pgno 597, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria of Vataja Pratishyaya (Allergic Rhinitis)
Subjects fit for Nasya karma
Subjects with signs & symptoms of Vataja Pratishyaya ,who are willing to enrol in the study by giving written consent
|
|
| ExclusionCriteria |
| Details |
Nasal polyps (anterior rhinoscopy & probe test )
Any abnormal nasal growth like Rhinoporidiosis, Rhinolith
Epistaxis
D.N.S. grade 1 (with anterior rhinoscopy)
Tumours of the nose
Acute Upper respiratory tract infection.
Other Systemic Disorders like Tuberculosis, Leprosy, uncontrolled DM and hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in reduction of prstishyaya lakshana like Nasavarodha Nasasrava Kshavathu Shirashoola Toda in Nasa Akshi Gala and Talu Kandu in Nasa Akshi Gala and Talu |
1st day Before treatment 30th day after treatment and 60th day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in AEC |
Baseline 1st day to 30th day after tretament |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
29/05/2025 |
| 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="2"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Title:Evaluation of Gudaardrak Nasya and Internal Gudaardrak in the Management of Vataja Pratishyaya (with special reference to Allergic Rhinitis) in Comparison with Rasanjanadi Taila Nasya Introduction -Allergic Rhinitis (AR) is an IgE-mediated chronic inflammatory condition of the nasal mucosa, affecting a large global population and significantly impairing quality of life. It is linked with complications such as sinusitis, asthma, and turbinate hypertrophy. Modern treatments provide symptomatic relief but often lead to side effects like mucosal atrophy or sedation. Ayurveda identifies AR with Vataja Pratishyaya, a subtype of Nasagata Roga. Among the treatments, Nasya Karma is highlighted as a prime modality to eliminate Doshas from Urdhvajatru regions. Gudaardrak (a combination of jaggery and ginger) is cited in Ayurvedic texts for its Vata-Kapha hara and mucolytic actions. It is hypothesized that the synergistic use of Gudaardrak Nasya along with internal administration may provide effective relief in Vataja Pratishyaya. This study aims to evaluate and compare the efficacy of this approach with Rasanjanadi Taila Nasya, a classical formulation. Methodology Study Design: Randomized Controlled Clinical Trial
Site: KAHER’s Shri B M K Ayurveda Mahavidyalaya, Belagavi
Ethics: Approved by Institutional Ethics Committee; CTRI registration to be completed Population: -
Inclusion: Adults aged 18–60 diagnosed with Vataja Pratishyaya, with Grade 1 DNS, and willing for Nasya -
Exclusion: Nasal polyps, tumors, acute URTI, or systemic disorders Sample Size: 52 participants in each group Dosage: -
Nasya: 6 drops bilaterally -
Internal: 1 Karsha (12 gm/day) in divided doses Assessment: -
Days: 1 (Baseline), 30 (Post-treatment), 60 (Follow-up) -
Parameters: Nasal discharge, blockage, sneezing, headache, itching and pricking pain in nose, eyes, throat, and palate -
Laboratory: AEC (Absolute Eosinophil Count) Statistical Tools: -
Descriptive stats, Chi-square, Mann-Whitney U-test, Wilcoxon matched pairs test, Student’s t-test -
Significance level: p < 0.05 Conclusion- use of Gudaardrak Nasya and internal Gudaardrak may offer significant relief in symptoms of Vataja Pratishyaya, potentially positioning it as a reliable and side-effect-free alternative in the Ayurvedic management of Allergic Rhinitis. |