CTRI/2025/07/091389 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On:
16/07/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Comparing Ayurvedic Nasal drops (Shadbindu Ghrita) and Common Nasal Spray (Xylometazoline) for managing Allergic Rhinitis (Chronic Runny Nose)
Scientific Title of Study
Evaluation of comparative efficacy of Navana Nasya with Shadbindu Ghrita versus 0.1 percent
Xylometazoline - Hydrochloride nasal drop in the management of Vataj Pratishyaya (Allergic Rhinitis):
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
Dr Darpan Madhao Borkar
Designation
PG Scholar
Affiliation
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Address
Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
India
Wardha MAHARASHTRA 442001 India
Phone
9561380194
Fax
Email
darpanborkar123@gmail.com
Details of Contact Person Scientific Query
Name
Dr Pramod Borghare
Designation
Professor
Affiliation
Mahatma Gandhi Ayurved College Hospital and Research Centre
Address
Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
India
Wardha MAHARASHTRA 442001 India
Phone
9881225532
Fax
Email
drpramodborghare@hotmail.com
Details of Contact Person Public Query
Name
Dr Darpan Madhao Borkar
Designation
PG Scholar
Affiliation
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Address
Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
India
Wardha MAHARASHTRA 442001 India
Phone
9561380194
Fax
Email
darpanborkar123@gmail.com
Source of Monetary or Material Support
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod, Hirapur, Wardha, Maharashtra
442001
India
Primary Sponsor
Name
Dr Darpan Madhao Borkar
Address
Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
India
Type of Sponsor
Other [Self]
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 Darpan Madhao Borkar
Mahatma Gandhi Ayurved College Hospital and Research Centre
Room No 24 Shalakyatantra OPD Mahatma Gandhi Ayurevd College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
INDIA Wardha MAHARASHTRA
0.1% Xylometazoline HCl nasal drops is a topical nasal decongestant acting as a selective α-adrenergic agonist. It causes vasoconstriction of nasal mucosa, reducing edema and congestion within 5–10 minutes, lasting up to 10 hours. Dose: 2–4 drops per nostril, 2–3 times/day for max 7 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
A patient who is willing to take part and provides signed informed consent, Patient having vataj Pratishyaya will be randomly selected, Selection is irrespective of gender, religion & socio economical class.
ExclusionCriteria
Details
Patients having Lower respiratory tract infections, Atrophic Rhinitis, C.S.F Rhinorrhoea and
any other systemic disease, recently operated patients (Nose cases), In lactating and pregnant women.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
1. To assess the efficacy of navan nasya with shadbindu ghrita on TNSS and DNE in Vataj Pratishaya (Allergic rhinitis)
2. To assess the efficacy of 0.1 percent Xylometazoline Hydrochloride nasal drop on TNSS and DNE in Vataj Pratishaya (Allergic rhinitis)
3. To compare the efficacy navan nasya with shadbindu ghrita and 0.1 percent Xylometazoline Hydrochloride nasal drop on TNSS and DNE in Vataj Pratishaya
(Allergic rhinitis)
1. Baseline (Day 0)- assessment of TNSS and DNE scores before intervention in both groups
2. Post-intervention (Day 14)- Reassessment of TNSS and DNE scores after completion of treatment in both groups.
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="56" Sample Size from India="56" 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)
27/08/2025
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="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
This study, titled Evaluation of comparative efficacy of Navana Nasya with Shadbindu Ghrita versus 0.1 percent Xylometazoline - Hydrochloride nasal drop in the management of Vataj Pratishyaya (Allergic Rhinitis) Randomized Controlled Trial, aims to compare an Ayurvedic nasal treatment with a modern nasal spray for allergic rhinitis. The research is important because while modern medicines offer quick relief, they can have side effects with long-term use, and there’s a lack of comparative studies for Ayurvedic alternatives. This study will involve 56 patients divided into two groups, receiving either the Ayurvedic treatment or Xylometazoline nasal drops for 7 days. The effectiveness will be measured using TNSS and DNE scores after 14 days to see if the Ayurvedic treatment is as effective as the modern nasal spray.
