| CTRI Number |
CTRI/2019/06/019823 [Registered on: 24/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of Haridrakahanda and Vyoshadi vati in the treatment of Allergic Rhinitis as prophyalctic medicine |
|
Scientific Title of Study
|
Comparative Clinical trial of efficacy of Haridrakahanda and Vyoshadi vati in the management of Allergic Rhinitis as prophyalctic medicine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshata kalje |
| Designation |
PG student |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Charitable Hospital girls hostel first floor room no 102 rastha peth Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9011640493 |
| Fax |
|
| Email |
akshata.kalje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salvi Sangeeta Santosh |
| Designation |
HOD and Guide Shalakyatnatra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya 2nd floor shalakyatantra department rastha peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshata Rajaram Kalje |
| Designation |
PG student |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Charitable Hospital girls hostel first floor room no 102 rastha peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9011640493 |
| Fax |
|
| Email |
akshata.kalje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya 2nd floor Shalakyatnatra depart department rastha peth pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Rastha peth pune411011 |
| 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 Akshata Rajaram Kalje |
Seth Tarachand Ramnath Charitable Hospital |
Opd building 1st floor opd no 15 Rastha peth pune 411011
Pune
MAHARASHTRA |
9011640493
akshata.kalje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
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 |
Haridrakhanada |
Haridrakhanda prepared by awaleha kalpana.given to patienta of age between 18 to 60 dose 5gm twice a day for 30 days n follow up will taken on 15th,30th,60th and 90th day |
| Comparator Agent |
Vyoshadi vati |
Vyoshadi vati prepared by vati kalpana given to patients of age between 18 to 60 dose 500mg twice a day for 30 days n follow up will taken on 15th 30th,60th,90th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed as alleegic rhinitis
|
|
| ExclusionCriteria |
| Details |
Patients with vasomotor rhinitis, acute infective rhinitis, atrophic rhinitis, pregnant women, lactating mother, patients suffering from malignancy, tuberculosis, systemic illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Haridrakahanda and Vyoshadi vati in the management of Allergic Rhinitis as prophyalctic medicine |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study efficacy of Haridrakahanda in management of allergic rhinitis as prophylactic medicine
To study the efficacy of vyoshadi vati in management of allergic rhinitis as prophylactic medicine
To study adverse effects of Haridrakhanada and Vyoshadi vati |
3 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Allergic rhinitis is one of the most commonest disease found due to this changes.allergic rhinitis is well known for its recurrence.Recurrence of disease occur only when vitiated doshas have not been eradicated completely. In allergic rhinitis principle of treatment is avoid allergens causing allergic reaction, detoxification, and prophylactic treatment to increase the immunity and to decrease Recurrence of disease. Haridrakhanada has anti allergic and antioxidant property. |