CTRI Number |
CTRI/2022/08/044908 [Registered on: 25/08/2022] Trial Registered Prospectively |
Last Modified On: |
18/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A Pharmaceutical analytical and Clinical pilot trial to evaluate efficacy of Herbal nasal spray in Allergic Rhinitis. |
Scientific Title of Study
|
PHARMACEUTICAL ANALYTICAL AND CLINICAL STUDY OF HERBAL NASAL SPRAY FOR ALLERGIC RHINITIS – PILOT STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Neerja Thakur |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurved |
Address |
Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India
Vadodara GUJARAT 391760 India |
Phone |
9780094524 |
Fax |
|
Email |
neerjathakur8@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anitha H |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurved |
Address |
Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India
Vadodara GUJARAT 391760 India |
Phone |
9739624874 |
Fax |
|
Email |
docvaishnavi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Neerja Thakur |
Designation |
PG SCHOLAR |
Affiliation |
parul institute of Ayurveda |
Address |
Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India
Vadodara GUJARAT 391760 India |
Phone |
9780094524 |
Fax |
|
Email |
neerjathakur8@gmail.com |
|
Source of Monetary or Material Support
|
Parul institute of Ayurved Parul university Limda Vadodara Gujarat |
|
Primary Sponsor
|
Name |
Department of Rasashastra and Bhaishajya Kalpana |
Address |
Parul institute of Ayurved Parul university |
Type of Sponsor |
Private medical 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 |
Dr Neerja Thakur |
Parul Ayurved Hospital |
OPD No 109 Department of Shalakyatantra Parul Ayurved Hospital Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India Vadodara GUJARAT |
9780094524
neerjathakur8@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
parul institute of ayurved-Institutional Ethics Committee for Human Research |
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: Herbal Nasal Spray, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Herbal Nasal Spray contains a combination of 3 drugs which are Bala (Sida cordifolia, Linn), Adaraka (Zingiber Officinalis Rosc), and Haridra (Curcuma longa Linn). |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Subjects willing for the trial.
2) Mild to moderate cases of Allergic rhinitis.
3) Subject in age group between 18 to 60 years.
|
|
ExclusionCriteria |
Details |
1) Subjects not willing for the trial.
2) Subjects below 18 and above 60 years.
3) Cases which require surgical intervention like nasal polyps and deviated nasal septum would be excluded.
4) Patients suffering from any chronic debilitating disease like Tuberculosis, Diabetes mellitus type 2, Asthma and other respiratory or nasal problems.
5)Pregnant ladies and lactating mothers. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of the symptoms of Allergic Rhinitis |
Efficacy of treatment will be analyzed by Assessment of symptoms on Gradation like 0, 1, 2, 3. Symptoms are 1)Running nose 2)Nasal blockage 3)Sneezing 4)Headache at baseline and at the end of 7 days. |
|
Secondary Outcome
|
Outcome |
TimePoints |
CBC
Absolute eosinophilic Count
|
Effect of treatment will be assessed on CBC, Absolute eosinophilic Count at baseline and at the end of 7 days |
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
01/09/2022 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Allergic Rhinitis
is an atopic disease. Allergy is a type-1 hypersensitivity reaction that
produces IgE antibodies to allergens i.e, pollen, dust, cold, and heat. In Ayurveda, various
symptoms of Vataja pratishaya like Tanu Nasa Srava,
Shirashoola, and Kshavathu are more relevant to symptoms of Allergic
rhinitis.
Multiple formulations are administered by different
routes to treat allergic rhinitis. Nasal route act on systemic as well as local
drug delivery route. Different dosage form through nasal routes includes nasal
spray, nasal drops, nasal powders, nasal gels, and nasal inserts.
Long-term
use of modern nasal sprays can damage the tissue, causing infection and pain.
Sometimes it swells even more than before. If the person continues to use it,
this swelling can get more severe and lead to permanent swelling of the tissue.
Hence Herbal nasal spray may help to overcome these side effects.
Ayurveda
medicine makes up an important component of the trend toward alternative
medicine. Bala is an Ayurvedic medicine that is used to treat
Influenza, Headache, Nasal Congestion, Cough, and Wheezing. Secondly, Haridra has been used for ages in different
inflammatory conditions of the respiratory tract due to active ingredients like
curcumin. Previous research studies proved that Adaraka (Ginger) has
alkaloids Gingerol, gingerdione, and zingiberene which are anti-oxidant,
antimicrobial, anti-inflammatory, anti-asthmatic, and Mucolytic in action.
The merits of the Nasal delivery route are that it ensures rapid absorption by
both systemic and local drug delivery routes. Also, very few preparations of
Nasal Spray are available in Ayurveda pharma companies that signify the
industrial applicability of the product. Hence, in this present study, an
attempt will make to prepare an herbal nasal spray for symptomatic treatment of
allergic rhinitis. |