| CTRI Number |
CTRI/2019/07/020107 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effectiveness of Daruharidra ghana vati compare to arogyavardhini vati in karnasrava. |
|
Scientific Title of Study
|
Comparative Clinical Study of efficacy of Daruharidra Ghana Vati and Arogyavardhini Vati In the Treatment Of Karnasrava |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mangesh Nandkishor Hegge |
| Designation |
Pg student |
| Affiliation |
Tilak Ayurved Mahavidyalay pune |
| Address |
OPD No. 15 second floor Seth Tarachand Ramnath Ayurvedic Hospital rasta peth pune
Azad chowk vairag tq barshi dist solapur.
Pune
MAHARASHTRA
411011
India |
| Phone |
8793473225 |
| Fax |
|
| Email |
mangeshhegge80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salvi Sangeeta Santosh |
| Designation |
Hod and guide shalakya tantra |
| Affiliation |
Tilak Ayurved Mahavidyalay pune |
| Address |
Shalakya tantra department
second floor Tilak Ayurved Mahavidyalay rasta peth pune.411011
Cps hostel shivajinagar pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
salvisangeeta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Nandkishor Hegge |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalay pune |
| Address |
Opd no. 15 second floor seth tarachand ramnath dharmarth ayurvedic rugnalaya rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822082795 |
| Fax |
|
| Email |
mangeshhegge80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyala pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalay pune |
| Address |
Rasta peth pune 411011 |
| 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 |
| Mangesh Hegge |
Seth Tarachand Ramnath Ayurvedic Hospital pune |
OPD no. 15. 2nd floor. Tarachand Ramnath dharmarth ayurvedic rugnalaya.Rasta peth pune 411011
Pune
MAHARASHTRA |
8793473225
mangeshhegge80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H650||Acute serous otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arogya vardhini vati |
Orally 500 mg tablet
Twice a daily with luke warm water for age group 18 to 60 yrs |
| Intervention |
Daruharidra Ghana Vati
|
Orally
500 mg with luke warm water twice daily for 15 days
Follow up on 5th 10th and 15th day for age grp 18 to 60 yr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sings and symptoms of karnasrava vyadhi
Tubotympanic disease
Patients willing for trials |
|
| ExclusionCriteria |
| Details |
Atticoantral disease
Csf otorrhoea
Patients not willing for trials |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Daruharidra Ghana Vati and Arogya vardhini vati in the treatment of karnasrava |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe side effects of Daruharidra Ghana Vati |
15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/07/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Karnasrava is the condition mentioned by different Acharyas in Ayurvedic texts. Prevalance rate of otitis media in India is 5 % Routine treatment of otorrhoea is to relieve cause,systemic antibiotics ,anti histaminics,anti inflammatory drugs Which are having many side effects. Daruharidra drugs have similar effects regarding all above mentioned drugs. Ayurvedic preparations are globally accepted but they required scientific data and evidence so proposed this topic |