| CTRI Number |
CTRI/2018/05/014165 [Registered on: 29/05/2018] Trial Registered Prospectively |
| Last Modified On: |
23/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Gojihvadi Syrup and Anu Taila Nasya in managing childhod recurrent cold |
|
Scientific Title of Study
|
Randomised clinical trial for determination of efficacy of Gojihvadi syrup and Anu taila nasya in managing childhood allergic rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Agrawal |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Kaumarabhritya Room No 208 OPD block All India Institute Of Ayurveda Gautampuri Sarita vihara New Delhi
Gautampuri Sarita Vihara New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9711681024 |
| Fax |
|
| Email |
manisha.agarwal089@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abhimanyu Kumar |
| Designation |
professor HOD |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Kaumarabhritya Room No 208 OPD block All India Institute Of Ayurveda Gautampuri Sarita vihara New Delhi
Gautampuri Sarita Vihara New Delhi
New Delhi
DELHI
110076
India |
| Phone |
8800543828 |
| Fax |
|
| Email |
ak_ayu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Department of Kaumarabhritya Room No 208 OPD block All India Institute Of Ayurveda Gautampuri Sarita vihara New Delhi
Gautampuri Sarita vihara New Delhi
New Delhi
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
All India Institute Of Ayurveda Gautampuri Sarita Vihara New Delhi |
| 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 |
| Manisha Agrawal |
ALL INDIA INSTITUTE OF AYURVEDA |
Gautam Puri Sarita Vihar
South West
DELHI |
9711681024
manisha.agarwal089@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 |
Childhood Allergic Rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anu taila |
Anu taila nasya 2 drops in each nostrils/day for 6 weeks |
| Intervention |
Gojihvadi syrup
Anu taila |
Gojihvadi syrup dose 7-8 years 36 ml/day TID,9-10 years 38 ml/day TID,11-12 years 40 ml/day TID,13-14 years 42 ml/day TID,15-16 years 44 ml/day TID for 6 weeks and Anu taila nasya 2 drops in each nostrils/ day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Cardinal features of Pratishaya like kasa, Nasa Srava, Ghranoparodha,
Gandhagyan, Galashotha, Shwaskashtata, Akshikandu, Sashabdaswaas, Shirahshoola,
Jwara, Kshwathu, Swarasada.
3. Recurrence of at least one episode every month for last one year or more.
4. Patients who are willing to participate in the study and come for follow up |
|
| ExclusionCriteria |
| Details |
Severe and Complicated respiratory allergic disorders.
2. Other respiratory infectious conditions such as Tuberculosis, Plural effusion,
Emphysema, Lung abscess, Bronchieactasis, pneumonia, Pleurisy.
3. Upper Respiratory complaints such as Nasal polyposis, Nasal tumours.
4. Congenital anomalies of respiratory tract.
5. Children with chronic debilitating diseases like JDM, HIV, HBsAg, immune
compromised children etc.
6. Patients who are not willing to be included in the study protocol and also who are not
willing to give the consent for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity score of Allergic rhinitis. |
Reduction in severity score of Allergic rhinitis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the Quality of Life of children in both the groups according to WHO. |
at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/05/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized comparative interventional parallel group clinical trial comparing the therapeutic efficacy and to evaluate the anti-allergic and immuno-modulatory effect of ANU TAIL NASYA (2 drops daily) with or without GOJIHVADI Syrup daily in doses as per the patient’s age for a period of 6 weeks in 100 patients of Respiratory Allergic Disorder that will be conducted in All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi. The primary endpoint measures will be reduction in the severity score of Allergic rhinitis assessed after 6 weeks of treatment. The secondary endpoint will be changes in the Quality of Life of children in both the groups. |