| CTRI Number |
CTRI/2025/04/084097 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the efficacy of Pippalyadi Nasal Spray in Allergic Rhinitis |
|
Scientific Title of Study
|
PHARMACEUTICO- ANALYTICAL AND CLINICAL STUDY OF PIPPALYADI
NASAL SPRAY IN VATAJA PRATISHYAYA WITH SPECIAL REFERENCE TO ALLERGIC RHINITIS
|
| 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 Chethan Kumar R |
| Designation |
PG SCHOLAR |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No.4 Department of Shalakya Tantra,JSS AYURVEDA MEDICAL COLLEGE and Hospital, #41/E, LALITHADRIPURA ROAD,Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
08971840893 |
| Fax |
|
| Email |
chethangowdru1912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nischitha M S |
| Designation |
Associate Professor |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No.4, Department of Shalakya Tantra, #41/E JSS AYURVEDA MEDICAL COLLEGE, LALITHADRIPURA ROAD,Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9448673838 |
| Fax |
|
| Email |
drnischitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nischitha M S |
| Designation |
Associate Professor |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No.4, Department of Shalakya Tantra, #41/E JSS AYURVEDA MEDICAL COLLEGE, LALITHADRIPURA ROAD,Mysuru
Room No.4, Department of Shalakya Tantra, #41/E JSS AYURVEDA MEDICAL COLLEGE, LALITHADRIPURA ROAD,Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9448673838 |
| Fax |
|
| Email |
drnischitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura ,Mysuru-570028, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Chethan Kumar R |
| Address |
#5,Sri lakshmi venkateshwara nivasa, Venkatappa Layout, B V Nagara, TCI,Bangalore-562162 |
| 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 Chethan Kumar R |
JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura ,Mysuru-570028, Karnataka, India |
Room No.4, Department of Shalakya Tantra OPD, 41/E, Lalithadripura Road, Mysuru, Karnataka 570028
Mysore
KARNATAKA |
08971840893
chethangowdru1912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Bresol NS, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: .16(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Nasal Spray, Reference: Yogaratnakara, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: .16(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling the diagnostic criteria
2.Subjects of all gender aged between 18-60 years will be selected
3.Subjects fit for Vataja Pratishyaya(Allergic Rhinitis). |
|
| ExclusionCriteria |
| Details |
1.Subjects with Nasal polyp, Epistaxis and previous history of surgery for Nasal and paranasal sinuses are excluded.
2.Subjects having any systemic diseases.
3.Other types of Rhinitis like Atrophic Rhinitis and Rhinitis Sicca, Rhinosporidiosis and Infective Rhinitis.
4.Pregnant Women and Lactating Mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of Symptoms of Vataja Pratishyaya(Allkergic Rhinitis |
2nd day, 8th day, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TNSS Score reduction
Nasal Cytology cel count reduction
Reduction in Turbinatr Hyprtrophy |
28days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="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
|
Ayurveda is a science
which deals with many unique therapies, which is intended to remove the
impurities from the roots. In this busy life, people do dislike to visit the
hospitals and carry over the therapies for long period of time, which makes
people attracted to the instant therapies which relieves the symptoms faster.
In charaka samhitha,
Shira is considered as uttamanga (1), which includes
Nasa, Netra, Karna and Mukha. One
such disease pertaining to Nasa is Vataja
Pratishyaya, which is characterized under nasagata rogas. It is described from samhitha kala in bruhatrayee as
well as laghutrayee.
Worldwide prevelance is 10-30% in adults, 40% in children(2).
The nasal route of drug delivery can be used for both local and
systematic drug delivery. For instance, localized nasal drug delivery is
usually used to treat conditions related to nasal cavity, such congestion,
rhinitis, sinusitis and allergic condition etc. A diverse range of drugs
including corticosteroids, anti-histamines, anticholinergic and
vasoconstrictors can be administered locally. The nasal delivery seems to be a
favourable way to circumvent the obstacles of blood-brain barrier.
The formulation Pippalyadi
Nasya is chosen from Yogaratnakara (3),
where in the drugs contain teekshna guna which
is responsible for the action of decongestion. The pharmacological activity of
the drugs shows its potent Immune stimulatory, Cough suppressor, Anti-
histamine. Hence this formulation has been chosen in Pratishyaya.
The modification of the dosage form i.e, Nasal spray helps
the mankind with the easy administration. It also helps the peoples who have
busy schedule and who are not able to visit the hospitals, an easy method which
can be administered immediately. As per the reference the dosage form of the formulation
is swarasa. The same has to be
converted into another dosage form with same ingredients i.e, Arka. This arka is further modified into nasal spray to increase its shelf
life and also for easy administration. The Nasal spray dosage form is cost-effective,
easy to carry. Hence “PHARMACEUTICO-
ANALYTICAL AND CLINICAL STUDY OF PIPPALYADI
NASAL SPRAY IN VATAJA PRATISHYAYA WITH
SPECIAL REFERENCE TO ALLERGIC RHINITIS” has been
taken.
PLAN
OF STUDY – GROUP A
(Trial group) – Pippalyadi Nasal
spray to each nostril thrice a day 2 Sprays = 0.16ml (13) GROUP B
(Control group)- Bresol Nasal Spray to each nostril thrice a day 2 sprays= 0.16ml Intervention Period: 7 Days Assessment schedule: On 0th Day On 8th Day Follow Up: On 15th Day
Total study duration: 15 days
|