| CTRI Number |
CTRI/2018/01/011195 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
06/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of recurrent cold since long time with the help of Shirishashwagandhadi avaleha with and without Anutaila Nasya |
|
Scientific Title of Study
|
Efficacy of Shirisha Ashwagandhadi Avaleha with and without Anutaila Nasya 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 |
Rozina A Khoja |
| Designation |
MS 2nd year |
| Affiliation |
Instite for Post Graduate Teaching and Research in Ayurveda |
| Address |
OPD 3, Shalakya tantra PG Ayurveda Hospital, IPGT and RA. GAU Jamnagar.
4th floor, department of Shalakya tantra, IPGT and RA,
GAU, Jamnagar
Valsad
GUJARAT
361008
India |
| Phone |
8866337312 |
| Fax |
|
| Email |
rozinakhoja28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anup B Thakar |
| Designation |
Head Department of Panchkarma IPGT and RA |
| Affiliation |
Instite for Post Graduate Teaching and Research in Ayurveda |
| Address |
4th floor Department of Panchkarma, IPGT and RA, GAU jamnagar. GUJARAT 361008, India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Anup B Thakar |
| Designation |
Head Department of Panchkarma IPGT and RA |
| Affiliation |
Instite for Post Graduate Teaching and Research in Ayurveda |
| Address |
4th Floor Department of Panchkarma, IPGT and RA, GAU Jamnagar. GUJARAT 361008 India.
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching And Research in Ayurveda. Gujarat Ayurveda university,Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
opp.city B Divison Police station PN Marg 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 |
| Rozina A Khoja |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Department of Shalakyatantra Opd no 3. Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar 361008
Gujarat
Jamnagar
GUJARAT |
8866337312
rozinakhoja28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with Allergic Rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Shirisha Ashwagandhadi Avaleha will be given 10 gms twice a day with luck warm water after meal and Anu taila Nasya 3 sittings of each 7 days. |
| Comparator Agent |
Group B |
Shirisha Ashwagandhadi Avaleha orally 10 gms twice a day with luck warm water after meal. |
|
|
Inclusion Criteria
|
| 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 |
1. Patient below 18 and above 50 years.
2. Cases which require surgical intervention like nasal polyps would be excluded.
3. Patients suffering from any chronic debilitating disease like T.B., D.M., Asthma and other respiratory or nasal problems.
4. Pregnant ladies and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptms of Vataja Pratishyaya |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves quality of life of the person |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
15/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is Randomized clinical trial to evaluate the efficacy of Shirisha Ashwaganndhadi Avaleha with and without Anutaila Nasya in the management of Allergic Rhinitis(Vataja Pratishyaya).Total 30 patients will be enrolled n the study.Selected patients will be divided in two groups on the basis of computer generated randomization. In this study Shirisha Ashwaganndhadi Avaleha will be given in dose of 10 gms twise a day after meal with luck warm water for 1 month with Anu taila Marsha Nasya 6 to 10 drops each nostrils 3 sittings of 7 days .In another group only Shirisha Ashwaganndhadi Avaleha will be given in dose of 10 gms twise a day after meal with luck warm for 1 month.Follow up will be carried out at 15 days interval for one month on routine medicine. |