| CTRI Number |
CTRI/2021/10/037097 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Sahijan taila in Vataja Pratishyaya (allergic rhinitis) |
|
Scientific Title of Study
|
Clinical study on the efficacy of Shigru taila Nasya in the management of Vataja Pratishyaya W.S.R to Allergic rhinitis |
| Trial Acronym |
STVP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dolly Kumari |
| Designation |
MS (Ayu) Scholar |
| Affiliation |
Government Ayurvedic college patna |
| Address |
MS (Ayu) Scholar,Department of Shalakya tantra, Government Ayurvedic College,Kadamkuan, Near Buddha murti,Patna
Patna
BIHAR
800003
India |
| Phone |
9435223048 |
| Fax |
|
| Email |
missdollysah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drprof Kumari Uma Pandey |
| Designation |
Prof cum HOD Shalakya tantra |
| Affiliation |
Government Ayurvedic college Patna |
| Address |
Prof Cum HOD Department of Shalakya tantra, Government Ayurvedic College,Kadamkuan, Near Buddha murti,Patna
Patna
BIHAR
800003
India |
| Phone |
9431646285 |
| Fax |
|
| Email |
dr.kumariuma@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dolly Kumari |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurvedic college Patna |
| Address |
Department of Shalakya tantra, Government Ayurvedic College,Kadamkuan, Near Buddha murti,Patna
Patna
BIHAR
800003
India |
| Phone |
9435223048 |
| Fax |
|
| Email |
missdollysah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college,Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic college Patna |
| Address |
Government Ayurvedic college,Kadamkuan Near Buddha murti, Patna |
| Type of Sponsor |
Government 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 Dolly Kumari |
Government Ayurvedic college and Hospital |
Department of shalakya/ENT OPD/Room No.3
Patna
BIHAR |
9435223048
missdollysah@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 Pratishyaya , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shigru taila, Reference: vangasena samhita nasarogadhikar 35/102, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shadbindu taila , Reference: Bhaisajya Ratnavalli 65/81-83, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients having specific lakshanas of vataja pratishyaya |
|
| ExclusionCriteria |
| Details |
patients below 10yrs and above 50yrs of age.
patients suffering from other systemic infectious disease.
patients suffering with nasal polyps,DNS,any other nasal mass. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign & symptoms of vataja pratishyaya |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in vataja pratishyaya |
2 months |
| Improvement in sign & symptoms of vataja pratishyaya |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2021 |
| Date of Study Completion (India) |
25/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
vataja pratishyaya is a first & foremost among the different type of pratishyaya in which there is vitiation of vata & kapha doshas resulting in profuse sneezing blocking of nose watery discharge dryness of mouth constant pain in temples & disorders of voice .it is compared with allergic rhinitis because most of the sign & symptoms are similar.in ayurveda all the acharyas have said about nasya karma for pratishyaya therefore shigru taila nasya has been selected as treatment for the present study. in modern aspect many treatment modalities are explained in form of medicine like corticosteroids,antiallergic etc but none of them are totally effective in curing the disease as well as to prevent its recurrence .moreover they have there own side effects so there is a need for more effective treatment to eradicate this problem from root base.for this purpose an effort is put into to find the effective treatment in series of patients sufferening from vataj pratishyaya which is well known for its recurrence and chronicity. shigru taila nasya is mentoned in vangsen samhita for general nasgata rogas. shigru tail drugs having ushana ,tikshana guna,vatakaphahar properties & having antiinflammatory action so it has sothahar,vednasthapana,sirsulhara ,analgesic action on vataja pratishyaya. in order to study the significance of this method of treatment a study on another group patients of vataja pratishyaya with shadbindu taila nasya which has alreday been established by previous study is also taken up. |