| CTRI Number |
CTRI/2020/11/029424 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
26/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Single arm open label clinical study to access the efficacy of Gudadi nasya in the management of karnanada |
|
Scientific Title of Study
|
Single arm open label clinical study to access the efficacy of Gudadi nasya in the management of karnanada |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRoshan Shivappa Iregaonkar |
| Designation |
MS Scholar Shalakya Tantra |
| Affiliation |
Dr.D.Y.Research Centre , Pimpri Pune 18 |
| Address |
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850594528 |
| Fax |
|
| Email |
roshaniregaonkar111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMayur Shiralkar |
| Designation |
Professor |
| Affiliation |
DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri,Pune 18 |
| Address |
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9422007951 |
| Fax |
|
| Email |
mayur.shiralkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoshan Shivappa Iregaonkar |
| Designation |
MS Scholar ShalyaTantra |
| Affiliation |
Dr.D.Y.Research Centre , Pimpri Pune 18 |
| Address |
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850594528 |
| Fax |
|
| Email |
roshaniregaonkar111@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18 |
|
|
Primary Sponsor
|
| Name |
DrRoshan Shivappa Iregaonkar |
| Address |
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrRoshan Shivappa Iregaonkar |
Dr.D.Y.patil college of ayurved and research centre pimpri pune |
OPD NO.4,DR.D.Y.Patil College of Ayurved and Research Centre , Pimpri, Sant Tukaram Nagar,Pune 18
Pune
MAHARASHTRA |
9850594528
roshaniregaonkar111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H833||Noise effects on inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gudadi nasya in the management of Karnanada |
30 patients will be taken who are suffering from Karnanada and treatment with Gudadi Nasya , 8 Drops for 7 days, 0th day and 7th day total 2 follow up |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female. between the age group of 18 to 80 yrs will be included in the study. patient suffering from ringing sound and deafness will be selected irrespective of their sex, education , socio economic status and religion. |
|
| ExclusionCriteria |
| Details |
1.patient not willing for trial
2.pregnant&lacting women.
3.patient who need surgical and other in intervention.
4.hypertension,malignancy,diabetic mellitus,
5.heart disease,&bronchial asthma,anemia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| single arm open label clinical study to access the efficacy of gudadi nasya in the management of karnanada. |
single arm open label clinical study to access the efficacy of gudadi nasya in the management of karnanada. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Conceptual - Study of Tinnitus/ Karnada as per Ayurved and
Tinnitus as per modern science.
1) To evaluate efficacy of Gudadi Nasya in the management of
Tinnitus (Karnada). |
Duration of treatment total 7 days and follow up 0th , 7th day. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2020 |
| 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="8"
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)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give ayurvedic treatment to diseased patient to improve his/ her condition and we can give his/her cheaf, safe side effect , free maganement the trail will be conducted on 30 patient for follow up 0th , 7thand dose of drug 8 Drops twice a time for 7 days |