| CTRI Number |
CTRI/2020/07/026416 [Registered on: 07/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study and compare the effect of Agaru Dhoopna and Guggula Dhoopana in Kranasrava. |
|
Scientific Title of Study
|
Randomised comparative clinical trial to study the effect of Agaruwadi Dhoopan and guggula Dhoopan in Karnasrava. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShradha Jaiwant Pandagale |
| Designation |
M.S.Schlor Shalakyatantra(Ayurvedic Dhanwantari) |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD No 8 Department of Shalakyatantra ,
Sane Guruji Aarogya Kendra,Malwadi Road, Hadapsar,Pune.Pin coad-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8669779363 |
| Fax |
|
| Email |
shradhapandagale018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMrsNilakshi Pradhan |
| Designation |
HOD and Professor of Shalakyatantra Department |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD.no 8 Department of Shalakyatantra,
Sane Guruji Arogya Kendra, Malwadi , Hadpasar,Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShradha Jaiwant Pandagale |
| Designation |
M.S.Schlor Shalakyatantra(Ayurvedic Dhanwantari) |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD No 8 Department of Shalakyatantra ,
Sane Guruji Aarogya Kendra,Malwadi Road, Hadapsar,Pune.Pin coad-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8669779363 |
| Fax |
|
| Email |
shradhapandagale018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra ,Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune. |
| 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 |
| DrShradha Pandagale |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune |
OPD NO.8 , Department of Shalakyatantra,Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune
Pune
MAHARASHTRA |
8669779363
shradhapandagale018@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 |
(1) ICD-10 Condition: H603||Other infective otitis externa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agaruwadi Dhoopana |
Agaruwadi Dhoopan 2 times/day for 7days |
| Comparator Agent |
Guggula Dhoopan |
Guggula Dhoopan 2 times /day for 7days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Karnasrava i.e.Karnashoola (pain)
Karnakandu (Itching), Badhirya (Conductive loss of hearing) |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any systemic disease like DM ,TB,HTN
2. Chronic suppurative otitis media.
3. Acute suppurative otitis media.
4. Perforation of Tympanic membrane.
5. Chronic otitis media.
6. Active otitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective criteria 1) Karnashool (pain) 2) karnakandoo 3) Karnasrava (itching) 4) badhirya |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the concept of Karnasrava and otomycosis in details.Study the Dhoopan karma and its use,indications and its complications |
8 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
10/07/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is particularly randomised comparative clinical trial to evaluate the effect of Agaruwadi Dhoopan given in Dhoopan form for 5min. two times per day for 7 days. Guggula Dhoopan given same as agaruwadi Dhoopan in karnasrava. The primary outcome will be effect of Agaruwadi Dhoopan in Karnasrava and secoundary outcome will be decrease the severity of Karnasrava. |