| CTRI Number |
CTRI/2019/01/017243 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of shirishaswagandhadiavleha and anutail nasya in the management of vataj pratishyay- Allergic rhinities. |
|
Scientific Title of Study
|
Efficacy of Shirisha Ashwagandhadi Avleha with and without Anutaila Nasya in the management of Vataja Pratishyaya (Allergic Rhinitis) -An open labeled randomized 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 |
Bhagyashree Potdar |
| Designation |
MS 2nd year |
| Affiliation |
Institue For Postgraduate Teaching & Research in Ayurveda |
| Address |
4th floor department of shalakya IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427765159 |
| Fax |
|
| Email |
bkpotdar1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DBVaghela |
| Designation |
associate prof IPGT&RA |
| Affiliation |
Institue For Postgraduate Teaching & Research in Ayurveda |
| Address |
4th floor department of shalakya IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DBVaghela |
| Designation |
associate prof IPGT&RA |
| Affiliation |
Institue For Postgraduate Teaching & Research in Ayurveda |
| Address |
4th floor department of shalakya IPGTandRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGT and RA GAU Jamnagar |
| Address |
Gujarat ayurveda university
JAmnagar |
| 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 |
| bhagyashree potdar |
PG hospital IPGT and RA, Jamnagar |
Gujarat ayurveda university jamnagar
Jamnagar
GUJARAT |
9427765159
bkpotdar1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IPGT RA jamnagar |
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 |
Shirisha Ashwagandhadi Avleha and Anutaila nasya in Allergic rhinities |
In Group A Shirisha Ashwagandhadi Avleha and Anutaila nasya will be given and in
Group B Shirisha Ashwagandhadi Avleha will be given |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria based on signs and symptoms of Vataja Pratishyaya (Allergic Rhinitis) in Ayurvedic classics and modern science will be selected for the present study. According to the Ayurvedic view:
a. Aanadhdha Pihita Nasa
b. Tanu Strava
c. Gala Talu Austha Shosha
d. Nistoda Sankhayo
e. Svaropa Ghata
According to the Modern view:
SYMPTOMS
a. Sneezing
b. Nasal discharge
c. Nasal blockage
d. Headache/heaviness of head
e. Itching in Nose, Eyes, Throat, Palate SIGNS
f. "Allergic shiners"
g. "Nasal crease" (allergic salute).
h. Swollen (boggy), pale, blue-gray nasal mucosa
2. Patients between the ages of 18 to 50 years of irrespective Sex Religion and Caste.
3. Patient willing and able to participate
|
|
| ExclusionCriteria |
| Details |
Below 18 and Above 50yr,surgical intervention like nasal polyp,T.B,D.M,Asthma and other respiratory diseases. Pregnant ladies and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of vataja pratishyay for 30 days of trialdrug. |
Relief in signs and symptoms of vataja pratishyay for 30 days of trialdrug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of vataja pratishyay for 30days of trialdrug |
Relief in signs and symptoms of vataja pratishyay for 30days of trialdrug |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2019 |
| Date of Study Completion (India) |
26/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/07/2019 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The trial is randomized clinical trial to evaluate the efficacy of shirishaswagandhadiavleha ashwagandhadi avaleha with and without anutail nasya in the management of Allergic rhinitis- vataja pratishyay.Total 30 patients will be enrolled in the study.selected patients will be divided into two groups on the basis of computer generated randomization.In this study shirishaswagandhadiavleha ashwagandhadi avleha will be given in dose of 10 gms twice a day after meal with Luke warm water for one month with anutaila Marsh nasya 6 to 10 drops each nostrils 3 sitting of 7 days.In another group only shirisha ashwagandhadi avleha will be given in dose of 10 gms twice a day after meal with Luke warm for 1 month.follow up will be carried out at 15 days interval for one month on routin medicine. |