| CTRI Number |
CTRI/2016/02/006661 [Registered on: 18/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of Allergic Rhinitis with oral medicine and nasal drops. |
|
Scientific Title of Study
|
A further study on Vataja Pratishyaya (Allergic Rhinitis) and its management with Anu Taila Nasya and Shirisha- Ashwagandhadi Avaleha. |
| Trial Acronym |
ARATSA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parth Prakashbhai Dave |
| Designation |
PhD Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalakya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9638948973 |
| Fax |
|
| Email |
drppdave88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharmendrasinh B Vaghela |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalakya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmendrasinh B Vaghela |
| Designation |
Assistant Professor |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalakya
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Gujarat Ayurved University Jamnagar – 361008 |
| 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 |
| Parth Prakashbhai Dave |
Department of Shalakya Tantra |
OPD no. 3 IPGT and RA Gujrat ayurved university jamnagar
Jamnagar
GUJARAT |
9638948973
drppdave88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 VIde Ref- PGT/7-A/2014-2015/2652 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo capsule |
In M group Placebo capsule of 500mg will be given once daily for 60 days. |
| Intervention |
Shirisha Ashwagandhadi Avaleha |
In Group A Shirisha Ashwagandhadi Avaleha will be given to 50 patients orally 10 gms twicw a day. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria based on sighns and symptoms of Vataja Pratishyaya (Allergic Rhinitis) according to Ayurvedic classics and modern science |
|
| ExclusionCriteria |
| Details |
Cases which require surgical intervention like nasal polyps would be excluded.
Patients suffering from any chronic debilitating disease like T.B., D.M., Asthma and other respiratory or nasal problems.
Pregnant ladies and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sign and symptoms of Allergic Rhinitis will subside. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life and functions of Pranavaha Srotas will improve |
till present study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/03/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
it is a RCT with MOST (Multiphase Optimization STrayegy) approach To evaluate the role of Shirisha Ashwagandhadi Avaleha and Anu Taila Nasya in the management of Allergic rhinitis. In one group Ayurvedic medicine which includes Shirish Ashwagandhadi Avaleha 10 gms twice a day and Anu Taila Pratimarsha Nasya (Imstilation of 2 drops of Anu Taila in both nostrils daily will be given to 50 patients for 60 days). other group is Placebo group in which Placebo capsule will be given once daily to 50 patients for 60 days. It is hypothesised in this study that Ayurvedic Medicine will be effective in treatment of Allergic rhinitis.
|