| CTRI Number |
CTRI/2019/06/019914 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
31/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of Ayurvedic drug in the management of Karnasrava w.s.r. to C.S.O.M. |
|
Scientific Title of Study
|
A randomised clinical trial of Karnapichu with Gandhaka Taila, Karnadhupana and Rasnadi Guggulu in the managemaent of Karnasrava w.s.r. to chronic suppurative otitis media (C.S.O.M.) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gulab Chand Pamnani |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Department OF Shalakya Tantra, National Institute Of Ayurveda, Joravar singh Gate, Amer road, Jaipur, Rajasthan, 302002, India
House no.104/33
Vijaypath,Mansarovar,Jaipur, 302020
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Pamnani |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Department OF Shalakya Tantra, National Institute Of Ayurveda, Joravar singh Gate, Amer road, Jaipur, Rajasthan, 302002, India
House no.104/33
Vijaypath,Mansarovar,Jaipur, 302020
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Nagar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur,Rajasthan |
| Address |
Department OF Shalakya Tantra, National Institute Of Ayurveda, Joravar singh Gate, Amer road, Jaipur, Rajasthan, 302002, India
C/O Biradhi Lal Nagar house no. 44-A shivpura dadabari Kota, Rajasthan,324009
Kota
RAJASTHAN
302002
India |
| Phone |
9462973774 |
| Fax |
|
| Email |
dr.meenanagar774@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, joravar Singh gate Amer road Jaipur,302002, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jaipur |
| Address |
National Institute Of Ayurveda, Amer Road, Joravar Singh Gate, Jaipur, 302002, Rajasthan, India |
| 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 Meena Nagar |
National Institute Of Ayurveda, Jaipur |
OPD no. 13, P G Department of Shalakya tantra, National Institute Of Ayurveda, Amer Road, Joravar singh Gate, Jaipur, 302002, Rajasthan,India
Jaipur
RAJASTHAN |
9462973774
dr.meenanagar774@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Karnadhupana locally along with Rasnadi Guggulu |
Karnadhupana outside the ear and into the external auditory canal twice daily for 30 days |
| Intervention |
Karnapichu with Gandhaka Taila along with Rasnadi Guggulu |
Karnapichu (8 to 16 drops) twice a day for 30days and Rasnadi Guggulu (500 mg)twice daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of karnasrava described as per Ayurvedic and modern parlance |
|
| ExclusionCriteria |
| Details |
1. Age below 8 years and above 60 years.
2. Systemic diseases like uncontrolled DM, Meningitis,Tuberculosis,HTN etc
3. History of long term intake of ototoxic drugs
4. C.S.O.M. with complications like acute mastoiditis, petrositis, facial paralysis, adenoids, tonsilitis, labyrithitis etc.
5. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Karnapichu with Gandhaka Taila,Karnadhupana and Rasnadi Guggulu in the management of Karnasrava(C.S.O.M.) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse event reported voluntarily, observed or enquired.Recurrence in sign and symptoms of Karnasrava(C.S.O.M.) |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
13/11/2019 |
| Date of Study Completion (India) |
08/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be a randomised clinical phase1 trial.The
screened patients will be randomly divided in two groups using computerized
randomization method for unbiased allocation.
Group A:
Patients will be treated with Karnapichu with Gandhaka
Taila along with Rasnadi
Gugglu.
Group B:Patients
will be treated with Karnadhupana along
with Rasnadi Guggulu.
Aims
and objectives:
- To study Karnasrava in both Ayurveda and modern
parlance.
- To evaluate the efficacy of Karnapichu and Karnadhupana on Karnasrava clinically.
- To evaluate the effect of Rasnadi Guggulu on Karnasrava clinically.
- To compare the efficacy of
trial drugs.
|