| CTRI Number |
CTRI/2025/07/090586 [Registered on: 09/07/2025] 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 the Effects of Pathadi Taila Nasya and Xylometazoline Nasal Drops in Managing common cold |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Pathadi Taila Navana
Nasya versus 0.1 percent Xylometazoline- Hydrochloride nasal
drop in the management of Peenas (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 Osama Abdul Nabi Shaikh |
| 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
Wardha
MAHARASHTRA
442001
India |
| Phone |
9049392283 |
| Fax |
|
| Email |
skossu786@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
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881225532 |
| Fax |
|
| Email |
drpramodborghare@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Osama Abdul Nabi Shaikh |
| Designation |
PG Scholar |
| 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
Wardha
MAHARASHTRA
442001
India |
| Phone |
9049392283 |
| Fax |
|
| Email |
skossu786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Osama Abdul Nabi Shaikh |
| 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Osama Abdul Nabi Shaikh |
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
Wardha
MAHARASHTRA
INDIA
Wardha
MAHARASHTRA |
9049392283
skossu786@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGACH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi Taila, Reference: Śārṅgadharapaddhati, Chikitsa Khanda, 9.181, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 0.1% Xylometazoline - Hydrochloride nasal drop | 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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
A patient who is willing to take part and provides signed informed consent, Patient having Peenas will be randomly selected, Selection is irrespective of gender, religion & socio economical class |
|
| ExclusionCriteria |
| Details |
Patients having Lower respiratory tract infections, 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the efficacy of Pathadi Taila Nasya on TNSS and DNE in peenas (rhinitis)
2. To assess the efficacy of 0.1 percent Xylometazoline - Hydrochloride nasal drop on TNSS and DNE
in peenas (rhinitis)
3. To compare the efficacy Pathadi Taila Nasya and 0.1 percent Xylometazoline - Hydrochloride nasal
drop on TNSS and DNE in peenas (rhinitis) |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms |
14 days |
|
|
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)
|
01/09/2025 |
| 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 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
|
This study, titled “Evaluation of comparative efficacy of Pathadi Taila Navana
Nasya versus 0.1% Xylometazoline- Hydrochloride nasal
drop in the management of Peenas (Rhinitis): Randomized
Controlled Trial”, aims to compare an Ayurvedic nasal treatment with a modern nasal spray for 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. |