| CTRI Number |
CTRI/2023/03/050434 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
The effect of Anu taila pratimarsha nasya along with Shirisha avaleha orally in the treatment of Vataj pratishyaya (Allergic rhinitis) |
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Scientific Title of Study
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To evaluate the effect of Anu taila pratimarsha nasya along with Shirisha avaleha orally in the management of Vataj pratishyaya (Allergic rhinitis) An open label double arm randomized controlled clinical trial |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
KARAN RATHOD |
| Designation |
Pg scholar |
| Affiliation |
|
| Address |
5th floor, Department of shalakya tantra, Academic block, All india institute of ayurveda, Mathura road, Gautam puri, Sarita vihar, New delhi, Delhi
South
DELHI
110076
India |
| Phone |
09098880826 |
| Fax |
|
| Email |
karankrathore707@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr PANKAJ KUNDAL |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
5th floor, Department of shalakya tantra, Academic block, All india institute of ayurveda, Mathura road, Gautam puri, Sarita vihar, New delhi, Delhi
South
DELHI
110076
India |
| Phone |
07291887810 |
| Fax |
|
| Email |
pankajkundal1146@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PANKAJ KUNDAL |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
5th floor, Department of shalakya tantra, Academic block, All india institute of ayurveda, Mathura road, Gautam puri, Sarita vihar, New delhi, Delhi
South
DELHI
110076
India |
| Phone |
07291887810 |
| Fax |
|
| Email |
pankajkundal1146@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of ayurveda, new delhi |
|
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Primary Sponsor
|
| Name |
All india institute of ayurveda, Director |
| Address |
All india institute of ayurveda, Mathura road, Gautampuri, Sarita vihar, New delhi |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr karan rathod |
All india institute of ayurveda |
Opd no. 102, 1st floor, Hospital block, All india institute of ayurveda, Mathura road, Gautampuri, Sarita vihar, New delhi
South
DELHI |
9098880826
karankrathore707@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, (2) ICD-10 Condition:J308||Other allergic rhinitis. Ayurveda Condition: VATAJ PRATISYAYAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirisha avaleha, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -(2) Medicine Name: Haridrakhanda, Reference: Astanghradya, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(3) Medicine Name: Anu taila, Reference: Astanghridaya, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the diagnostic criteria which are based on symptomatology of Vataja Pratishyaya – Allergic Rhinitis in Ayurvedic classics and modern science will be selected for the present study. |
|
| ExclusionCriteria |
| Details |
1.Rhinitis caused by virus, bacteria etc.
2.Hypertrophic rhinitis
3.Atrophic rhinitis
4.Rhinitis sicca
5.Patient, suffering from systemic diseases like T.B., D.M. etc.
6.Pregnant women and lactating mother.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the clinical features like sneezing, runny nose etc of allergic rhinitis assessed through specific questionnaire and tools. |
At baseline and 30 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in haematological parameters (CBC with ESR, IgE) |
At baseline and 30 days |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
16/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/06/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Pratishyaya has been a major problem to the physicians since long back. In Ayurveda a detailed description of Pratishyaya and its types are explained. The features of Vataja Pratishyaya in general are similar to that of allergic rhinitis in modern science. Throughout the world, the prevalence of allergic rhinitis has slightly escalated. Currently, approximately 10 to 30% of adults and 40% of children are affected. The European Community Respiratory Health survey recorded a prevalence of 10 to 41% in adults with allergic rhinitis.Shirisha avaleha contains shirisha, Pippali, Priyangu, Kushta, Ela, Nilini, Haridra, Daruharidra, Shunthi, Nagakesara, Guda, Jala. In this formulation which properties Shothhara, Swasahara, Deepan, Anulomana, Vatashamaka probably can control the allergic condition and improves the Vyadhikshamatva (Immunomodulatory). Due to all these properties Shirisha Avaleha is being given in Vataja Pratishyaya.
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