| CTRI Number |
CTRI/2025/02/081445 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare efficacy of Vachadi Kashaya and Shunthyadi Taila Nasya in Vataja Pratishyaya (Allergic Rhinitis) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vachadi Kashaya And Shunthyadi Taila Nasya In The Management Of Vataja Pratishyaya W.S.R. 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 Vikram Saini |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
P.G. Department of Shalakya Tanta.
Madan Mohan Malviya Government Ayurved College and Hospital
O.P.D. No. 9 &10
Udaipur(313001),Rajasthan,India
P.G. Department of Shalakya Tanta.
Madan Mohan Malviya Government Ayurved College and Hospital
O.P.D. No. 9 &10
Udaipur(313001),Rajasthan,India
Udaipur
RAJASTHAN
313001
India |
| Phone |
8824483316 |
| Fax |
|
| Email |
vikramsaini300590@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
P.G. Department of Shalakya Tantra.
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
P.G. Department of Shalakya Tantra.
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
P.G. Department of Shalakya Tantra.
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
P.G. Department of Shalakya Tantra.
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India |
| 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 Vikram Saini |
Madan Mohan Malviya Government Ayurved College and Hospital, Udaipur |
P.G. Department of Shalakya Tanta.
Madan Mohan Malviya Government Ayurved College and Hospital
O.P.D. No. 9 &10
Udaipur(313001),Rajasthan,India
Udaipur
RAJASTHAN |
8824483316
vikramsaini300590@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. Govt. Ayurved College Ambamata Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Chakradatta chapter 58/10, Procedure details: Medicated drops will be administered in nose.)
(1) Medicine Name: Shunthyadi Taila, Reference: Chakradatta chapter 58/10, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vachadi Kashaya, Reference: Harit Samhita Sthan 3,Chapter 2/49, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients willing to participate in the study.
ii.The patients having age in between 18-60 years will be selected.
iii. Patients presenting with sign and symptoms of Vataja Pratishyaya mentioned in Ayurvedic Classics and of Allergic Rhinitis according to modern science. |
|
| ExclusionCriteria |
| Details |
i. Patients having history of systemic disease as Diabetes Mellitus, Hypertension, Hypothyroidism etc.
ii. Patients suffering from gross deviation of nasal septum, nasal tumors, adenoidal hyperplasia, nasal polyps etc.
iii. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Vataja Praitishyaya w.s.r. to allergic rhinitis after treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other associated symptoms. |
15th day, 30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a clinical trial to compare efficacy of shunthyadi taila nasya and Vachadi kashaya on vataja pratishyaya with special reference to allergic rhinitis . In this trial 2 groups
each of 30 patients will be selected. Group A will be administered with Vachadi kashaya 2 Pal(100 ml) orally. Group B will be administered
with Vachadi kashaya 2 Pal(100 ml) orally along with shunthyadi taila nasya. |