| CTRI Number |
CTRI/2022/02/040468 [Registered on: 21/02/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role Of Jala Neti And Pratimarsha Nasya In The Management Of Vataj Pratishaya (Allergic Rhinitis ) |
|
Scientific Title of Study
|
A Comparative Clinical study On The Role Of Jala Neti And Pratimarsha Nasya In The Management Of Vataj Pratishaya (Allergic Rhinitis ) |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemant Kumar |
| Designation |
Ayurvedic Medical Officer |
| Affiliation |
Guru Ravidas Ayurvedic university Hoshiarpur Punjab |
| Address |
Govt. Ayurvedic Hospital Model Gram ludhiana
Ludhiana
PUNJAB
141002
India |
| Phone |
8427640022 |
| Fax |
0 |
| Email |
hemantpatialvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Sharma |
| Designation |
Professor in the Dept. of Swathavritta |
| Affiliation |
Dhanwantri Ayurvedic College |
| Address |
Dhanwantari Ayurvedic College Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
0 |
| Email |
neerjasharma2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemant kumar |
| Designation |
Ayurvedic medical officer |
| Affiliation |
Guru Ravidas Ayurvedic University |
| Address |
Guru Ravidas Ayurvedic University
Vpo kharkan Una Road Hoshiarpur Punjab
Hoshiarpur
PUNJAB
146110
India |
| Phone |
8427640022 |
| Fax |
0 |
| Email |
hemantpatialvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Ayurvedic Hospital Model Gram Ludhiana |
|
|
Primary Sponsor
|
| Name |
Dr Hemant kumar |
| Address |
Govt.Ayurvedic Hospital Model gram ludhiana |
| 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 |
| Hemant kumar |
Govt .Ayurvedic hospital |
Model gram Opposite Sampurna Palace O.P.D Room No - 1
Ludhiana
PUNJAB |
8427640022
0
hemantpatialvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GuruRavidasAyurvedicUniversityHoshiarpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: Vataja Pratishaya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Jala Neti | Group A Patients are advised to perform Jalaneti in the morning on an empty stomach for a period of 28 days. | | 2 | Comparator Arm | Procedure | - | Pratimarsha nasya | (Procedure Reference: Astang Haridya, Procedure details: Group B Patients will be advised to instill Anu tail two drops in each nostril every morning empty stomach for 28 days)
(1) Medicine Name: Anu tail, Reference: Astang Haridya, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 28 Days | | 3 | Comparator Arm | Procedure | - | Jala Neti /Pratimarsha nasya | (Procedure Reference: Gherand Samhita/Astang Haridya, Procedure details: Group C Patients will be advised to perform Jalaneti in the morning on empty stomach and after that instill two drops of Anu tail in each Nostril for a period of 28 days)
(1) Medicine Name: Anu Tail, Reference: Astang Haridya, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from vataj pratishyaya (Allergic Rhinitis)
The selection of the patient will be irrespective of their Sex,Religion,Socioeconomic status
Patient ready to give written consent
|
|
| ExclusionCriteria |
| Details |
Patients suffering from a Nasal polyp Epistaxis Benign and Malignant tumors Tuberculosis Hypertension and Diabetes will be excluded
Pregnant women will also excluded
Patients suffering from any other systemic disorder and on any other medications will also excluded
Patient having any Nasal congenital deformity will not taken for this study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Normalization in Absolute Eosinophil Count (AEC) Improvement in clinical features of Vataj Pratishyaya like nasal congetion , Nasasrava , Kshavathu ,kasa , Shirashoola etc.
|
0th 7th 14th 21th 28th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in frequency of attack of Vataj Pratishyaya
It can help in alleviating anxiety, anger and depression , asthama , relieve disorders of Urdhavajatrugata rogas like ears, eyes and throat .
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
26/02/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication still |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 26-02-2022 and end date provided 25-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Allergic rhinitis is most common disease affecting all age group of either sex. Allergic rhinitis has a close resemblance with vataja pratishyaya in Ayurveda. The clinical features of Vataj Pratishyaya are Kshavathu , Aanadha Nasa (nasal obstruction), Nasa Srava (nasal discharge), Talu Ostha Shosha (dryness of throat, palate and lips) ,Shankha Nistoda (Pain at temporal region),Hoarseness of voice, Shiro Gauravatahead, Gala, Ostha, Talu, Nasa and Netra Kandu (throat, lips, palate, nose and eyes) . According to Yoga, Jalaneti is one of the important cleaning processes described in yoga for nasal passage. Nasyakarma is one of the important procedures of Panchkarma and it is very useful in the management of Urdhavajatrugata rogas, Pratimarsha nasya is used for daily regime for maintain Nasa swasthya. So a clinical study will be conducted on Diagnosed Patients with Vataj Pratishyaya (allergic rhinitis) for the period of 28 days. Patients were divided into three groups Each consisting of 40 patients ,Group A will be treated with Jalaneti , Group B will be treated with Anu Tail Pratimarsha Nasya and Group C will be treated with Jalaneti and Anu Tail Pratimarsha Nasya. Observation on parameters was done on 0th ,7th, 14th, 21th, 28th day of the Treatment. Analysis of symptoms will be done statistically on the basis of results obtained in objective and subjective Parameters . Conclusion will be done on the basis of Analysis of the data obtained |