CTRI/2025/12/099912 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On:
29/12/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda Nutraceutical
Study Design
Randomized, Parallel Group Trial
Public Title of Study
“A clinical study to evaluate the effect of an Ayurvedic nutraceutical supplement Nasaamrutam combined with nasal oil drops Anu Taila and Shirishavaleha in patients with Allergic Rhinitis.”
Scientific Title of Study
Evaluation of the add-on effect of a traditional nutraceutical supplement ‘Nasaamrutam ’ with Anu Taila Pratimarsha Nasya and Shirishavaleha orally in the management of Vataja Pratishyaya (Allergic rhinitis) - An open-label double-arm randomized 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 Aastha Agrawal
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
Room No. 505
Department of Shalakya Tantra
5th floor, Academic Block, All India Institute of Ayurveda, Sarita Vihar,New Delhi
South DELHI 110076 India
Phone
9079383947
Fax
Email
agrawalaastha1998@gmail.com
Details of Contact Person Scientific Query
Name
Dr Manjusha Rajagopala
Designation
Professor and Head of Department
Affiliation
All India Institute of Ayurveda
Address
Room No.501
Department of Shalakya Tantra
5th floor, Academic Block, All India Institute of Ayurveda, Sarita Vihar,New Delhi
South DELHI 110076 India
Phone
9560788850
Fax
Email
bhatrajma2008@gmail.com
Details of Contact Person Public Query
Name
Dr Aastha Agrawal
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda
Address
Room No. 505
Department of Shalakya Tantra
5th floor, Academic Block, All India Institute of Ayurveda, Sarita Vihar,New Delhi
South DELHI 110076 India
Phone
9079383947
Fax
Email
agrawalaastha1998@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda, Mathura Road, Gautampuri Awas, Sarita Vihar, New Delhi,110076
Primary Sponsor
Name
All India Institute of Ayurveda
Address
Mathura Road, Gautampuri Awas, Sarita Vihar, New Delhi,110076
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Aastha Agrawal
All India Institute of Ayurveda
OPD No.102, 1st floor ,Hospital block, Department of Shalakya Tantra,Mathura Road, Gautampuri Awas, Sarita Vihar South DELHI
9079383947
agrawalaastha1998@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee, All India Institute of Ayurveda
(Procedure Reference: Astanga Hridaya, Procedure details: Nasya karma is the name given to the procedure of administering medicines through the nasal route (trans-nasal medication). Among various types of nasya, Pratimarsha Nasya is a special type of Snehana Nasya with low dose , minimal complications & can be self-administered. Method of administration:- By lying down in supine position with head & neck low position; it is advised to instil 4 drops of medicated oil/ghrita in each nostril (closing/pinching the other nostril) and sucking the oil up. Thereafter, repeat the same for the other nostril. It is then instructed to spit the medication when it reaches the throat.)) (1) Medicine Name: Anu Taila, Reference: Astangahrdaya, Sutrasthana, Adhyaya 20; 37-38, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Duration: 30 Days
(Procedure Reference: Astanga Hridayam, Procedure details: Nasya karma is the name given to the procedure of administering medicines through the nasal route (trans-nasal medication). Among various types of nasya, Pratimarsha Nasya is a special type of Snehana Nasya with low dose , minimal complications & can be self-administered. Method of administration:- By lying down in supine position with head & neck low position; it is advised to instill 4 drops of medicated oil/ghrita in each nostril (closing/pinching the other nostril) and sucking the oil up. Thereafter, repeat the same for the other nostril. It is then instructed to spit the medication when it reaches the throat.) (1) Medicine Name: Anu Taila, Reference: Astanga Hridayam, Sutrasthana, Adhyaya 20; 37-38, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Duration: 30 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
1.Presence of Kshavathu (sneezing) as a mandatory symptom.
2.Patients having 3 or more diagnostic symptoms (either intermittent or persistent pattern) of Vataja Pratishyaya,i.e.,
i.Nasasrava (rhinorrhea)
ii.Nasauparodha (nasal blockage)
iii.Mukhashosha (dry mouth)
iv.Shirashoola (headache)
v.Nasa–bhru kandu (itchy nose –eyebrow)
- for a minimum of one year immediately preceding the study- Screening Visit
ExclusionCriteria
Details
1.Patients having lower respiratory tract infection.
2.Upper respiratory tract complaints such as nasal polyposis, nasal tumors, CSF rhinorrhea.
3.Patients with adenotonsillar hypertrophy, craniofacial syndromes, or neuromuscular diseases.
4.Patients with history of nasal surgery.
5.Other respiratory infectious conditions such as tuberculosis, pleural effusion, emphysema, lung abscess, bronchiectasis, pneumonia, pleurisy,etc.
6.Congenital anomalies of respiratory tract or rhinitis due to trauma.
7.Patients suffering from chronic debilitating diseases like HIV, Hepatitis-B, immuno- compromised patients etc.
8.Patients suffering from systemic diseases such as hypertension , diabetes mellitus etc.
9.Patients not willing to participate in the study.
Method of Generating Random Sequence
Permuted block randomization, variable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Improvement in Kshavathu (sneezing) in Vataja Pratishyaya - Allergic Rhinitis.
Day 0 (Baseline evaluation), 15th day, 30th day, 60th day (Follow-
up)
Secondary Outcome
Outcome
TimePoints
Improvement in other symptoms of Vataja Pratishyaya -Allergic Rhinitis viz., Nasavarodha (Nasal
obstruction), Kandu (Itching), Kasa (Cough), Shirahshul/ Shirogaurav (Headache),
Gandhagyan (Loss of smell), Swarbheda (Hoarseness of voice).
Day 0 (Baseline evaluation), 15th day, 30th day, 60th day (Follow-
up)
Decrease in the AEC (
cells/microlitre of blood)
and serum IgE levels
(IU/mL)
Day 0 (Baseline evaluation), 15th day, 30th day, 60th day (Follow-
up)
Target Sample Size
Total Sample Size="64" Sample Size from India="64" 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 1
Date of First Enrollment (India)
15/05/2026
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
Vataja Pratishyaya, described in Ayurveda as a Nasagata Roga, closely correlates with allergic rhinitis, a highly prevalent IgE-mediated inflammatory condition affecting the nasal mucosa. Allergic rhinitis significantly impairs quality of life and has a rising prevalence in India and globally, especially among adolescents. Conventional treatments provide symptomatic relief but are often associated with adverse effects and poor long-term compliance. Hence, there is a growing need for safe, effective, and holistic alternatives. Ayurveda offers well-established therapeutic modalities for Vataja Pratishyaya, including Anu Taila Pratimarsha Nasya for preventive and curative care of nasal disorders and Shirishavaleha for its anti-allergic, anti-inflammatory, and immunomodulatory properties. Previous clinical evidence has shown notable symptomatic improvement with this combination. The present study aims to evaluate the add-on effect of a traditional ready-to-drink nutraceutical supplement, Nasaamrutam, when combined with Anu Taila Pratimarsha Nasya and Shirishavaleha.
Nasaamrutam, formulated with ingredients such as poppy seeds, black pepper, almonds, nutmeg, cardamom, and muskmelon seeds, is traditionally valued for respiratory soothing, immune support, and anti-inflammatory actions. This open-label, double-arm randomized controlled clinical trial seeks to assess whether the addition of Nasaamrutam enhances therapeutic outcomes in Vataja Pratishyaya compared to the standard regimen alone, while also improving palatability and patient compliance with minimal side effects.