| CTRI Number |
CTRI/2024/08/072252 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Vataj pratishyaya(Allergic Rhinitis)i.e. nasal congestion , rhinorrohea and nasal itching through nidigdhika avaleha and shadbindu taila nasya |
|
Scientific Title of Study
|
An Exploratory Single arm Study on the efficacy of Nidigdhika Avaleha with Shadbindu Taila nasya in vataj pratishyaya(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 Anushka chauhan |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved ,jodhpur
Jodhpur
RAJASTHAN
342037
India
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Jodhpur
Rajasthan
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7374021382 |
| Fax |
|
| Email |
chauhananshu1102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Jodhpur
Rajasthan
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07976967729 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Jodhpur
Rajasthan
PG Department of Agad Tantra Post Graduate Institute of Ayurved
Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07976967729 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Jodhpur 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved
jodhpur 342037 |
| 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 Anushka chauhan |
Sanjeevani Hospital |
Room No. 113,
PG department of Agad
tantra
Post graduate
institute of ayurved
DsRRAU
Jodhpur
RAJASTHAN |
07374021382
chauhananshu1102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Ayurved Jodhpu |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nidigdhika avaleha, Reference: Bhav prakash Svarbheda, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadbindu taila, Reference: Siddha yoga sangrah adhyaya 46, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patient of allergic rhinitis willing to participate in the trial.
2. Patients above 18 years of age will be taken.
3. Patients presenting with signs and symptoms of Vataja Pratishyaya mentioned in Ayurvedic
classics & of Allergic rhinitis according to modern texts. |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18 years .
2. Patients not willing for trial.
3. Those having history of Bronchial asthma, Hypertension & Diabetes mellitus .
4 .Pratishyaya due to systemic disorders (like T.B., Syphilis).
5. Those with any inflammatory disease & those requiring surgical treatment of nasal region
(for eg. Nasal polyp).
6. Other Doshaja Pratishyaya, (other than Vataja Pratishyaya & Allergic rhinitis). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Vataj Pratishyaya (Allergic rhinitis) |
Reduction in signs and symptoms of Vataj Pratishyaya (Allergic rhinitis) within 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Absolute Eosinophill Count |
30 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="10"
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
|
METHODOLOGY Type of study :Interventional Purpose : Treatment / Efficacy Timing : Prospective End point : Effectiveness Duration : 30 days Sample size : 40
Criteria for selection :
Clinically diagnosed and registered patients of Peenas (Allergic rhinitis ) history attending the
OPD of Post Graduation Institute of Ayurveda, Jodhpur and various medical camps
conducted by department of Agad tantra.
Posology:
Drug :Nidigdhika Avaleha Kalpana: Avaleha Dose: 6 gram Anupana: Luke warm water Route of administration :Oral Time of administration :Twice a day (After meal) Duration : 30 days
Drug: Shadbindu taila Kalpana:Taila Dose: 2 drops Route of administration : Nasal Time of administration : Morning and evening (empty
stomach) Duration : 30 days
Follow up: 1. Duration of clinical study will be 30 days. 2. All patients will be followed up once in 10th day regularly. 3. Improvements and other effects will be noted. 4.Clinical assessment will be done once in 10th day. 5.Pathya ahara and vihara will be noted during follow up.
|