| CTRI Number |
CTRI/2019/07/020155 [Registered on: 12/07/2019] Trial Registered Prospectively |
| Last Modified On: |
09/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of shigru taila nasya and pippalyadigana vati in vataja pratishyaya (allergic rhinitis) |
|
Scientific Title of Study
|
Evaluation of shigru taila nasya and pippalyadigana vati in the management of vataja pratishyaya (allergic rhinitis)-A comparative clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Rao |
| Designation |
Associate Professor |
| Affiliation |
Rishika campus haridwar UAU |
| Address |
Dep. Of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Dep. Of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077151820 |
| Fax |
|
| Email |
docrenuprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Rao |
| Designation |
Associate Professor |
| Affiliation |
Rishika campus haridwar UAU |
| Address |
Dep of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Dep of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077151820 |
| Fax |
|
| Email |
docrenuprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Rao |
| Designation |
Associate Professor |
| Affiliation |
Rishika campus haridwar UAU |
| Address |
Dep of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Dep of shalakya tantra, Rishikul campus haridwar uttarakhand ayurved university
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077151820 |
| Fax |
|
| Email |
docrenuprasad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Ayurvedic college haridwar, UAU university |
|
|
Primary Sponsor
|
| Name |
Rishikul campus |
| Address |
Rishikul campus UAU haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Dubey |
Rishikul campus haridwar |
Department of shalakya Tantra rishikul campus haridwar, OPD room no 5
Hardwar
UTTARANCHAL |
9479620644
dubepriyanka.267@gmail.com |
|
|
Details of Ethics Committee
|
| 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Group A 20 patients,3 sitting of Marsha nasya (nasal route) with shigru taila 8drops in each nostril for 7 days each will given with a gap of 7 days in between each sitting and 2 sitting of pratimarsha nasya with shigru taila 2 drop in each nostril for 7 days in between gap of Marsha nasya will be given. |
| Comparator Agent |
Group B |
Number of patients 20, nasya with shigru taila and pippalyadigana vati will be given. Shigru taila nasya dose and duration are same as group A and pippalyadigana vati 2 BD of 250mg twice a day will given. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fullfill the diagnostic criteria based on sign and symptoms of vataja pratishyaya and allergic rhinitis
Minimum 3 recurrent attack of sign and symptoms of vataja pratishyaya and allergic rhinitis |
|
| ExclusionCriteria |
| Details |
Patients suffering from chronic or acute sinusitis, rhinitis other than allergic rhinitis, other nasal pathology like DNS., polyp
Patients suffering from any chronic systemic disease like Dm, HTN, tuberculosis, lower respiratory tract disease
Patients who have taken any antihistaminic, mast cell stabilizer, nasal corticosteroid or any other nasal anatomic variants in nose since two weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cured 90% relief in sign and symptoms
Marked improvement 76-90%
Moderate improvement 51-75%
Mild improvement 26-59%
No improvement less than 25% |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| aggravation of symptoms |
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| 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="4"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
trial yet to be started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda is an ancient system of life. On reviewing the clinical presentation from the classical ayurvedic text the sign and system of vataja pratishayaya nearly simulate with the disease Allergic Rhinitis. The present study on shigru taila and pippalyadigana vati has been taken which has its pharmacological properties like vata kapha shamak , Anuloman, Vishaghana. In study 40 patients of vataja pratishyaya will be taken in two groups 20 patient in each on the basis of inclusion and exclusion criteria and shigru taila nasya in first A group and oral administration of pippalyadigana vati with shigru taila nasya in second B group will be given. the trial duration will be 35 days.
|