| CTRI Number |
CTRI/2024/06/068457 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Karnapooran and Nasya with Eranda Shigruvadi Taila along with Ghritpana in the Management of Karna Badhirya or Sensorineural Hearing Loss. |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Efficacy of Karnapoorana and Nasya with Eranda Shigruvadi Tail along with Ghritpana in the Management of Karna Badhirya w.s.r. to Sensorineural hearing loss. |
| Trial Acronym |
SNHL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrawan Kumar Gupta |
| Designation |
PG Scholar |
| Affiliation |
Goverment Ayurvedic college and Hospital Kadamkuan Patna |
| Address |
Department of shalakya tantra Government Ayurvedic college and Hospital Kadamkuan Patna 800003 Bihar
Patna
BIHAR
800003
India |
| Phone |
8757493735 |
| Fax |
|
| Email |
drshrawangupta75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Mittal |
| Designation |
Assistant professor |
| Affiliation |
Goverment Ayurvedic college and Hospital Kadamkuan Patna |
| Address |
Department Of Shalakya tantra Government Ayurvedic college and Hospital Kadamkuan Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7783092350 |
| Fax |
|
| Email |
drmamtania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Mittal |
| Designation |
Assistant professor |
| Affiliation |
Goverment Ayurvedic college and Hospital Kadamkuan Patna |
| Address |
Department Of Shalakya tantra Government Ayurvedic college and Hospital Kadamkuan Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7783092350 |
| Fax |
|
| Email |
drmamtania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna 800003 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic college Health Department Government of Bihar |
| Address |
Government Ayurvedic College and Hospital Kadamkuan Patna 800003 |
| Type of Sponsor |
Government medical college |
|
|
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 Mamta Mittal |
Government Ayurvedic College and Hospital Patna |
Room no 3 Department of Shalakya Tantra GACH Patna Bihar
Patna
BIHAR |
07783092350
drmamtania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurvedic College and Hospital Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Karna Pooran and Nasya Pradhan Karma | (Procedure Reference: Astang Hridayam, Procedure details: Karna Pooran for 7 days followed by a gap of 7 days total 3 sittings.
Nasya 7 days followed by a gap of 7 days total 3 sittings.)
(1) Medicine Name: Erand Shigruvadi Taila, Reference: Astang Hridayam, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(ml), Frequency: od, Duration: 42 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual within age group between 20 to 60 years will be included in the study.
2. Patient suffering from sensory neural hearing loss will be selected irrespective of either sex, education, socioeconomic status and religion.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 20 years and above the age of 60 years.
2. Patient diagnosed with conductive hearing loss.
3. Patient not willing for trial.
4. Pregnant and lactating women.
5. Patients who need surgical and other treatment intervention.
6. Patient suffering from systemic disease
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of the intervention |
day7,day14,day21,day28,day35,and day42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of the effect of intervention with respect to other in general |
day7,day14,day21,day28,day35 & day42. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/06/2024 |
| 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="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are so many drugs against several of health issues are indicated in Ayurveda. One such example is mentioned in Astang Hridyam in their Karna Rogadhikar, where a number of medicines are described among them due to easily formulation and great application of Erand Shigruvadi Taila for Karna Pooran as well as Nasya in our department (dept. of Shalakya Tantra, Govt. Ayurvedic College and Hospital, Patna) have decided that there must be a work has needed on this, so that it can be used as in general practice against the health issues for which it has been indicated in Ayurveda. That is why this work "A Comparative Clinical study on the efficacy of Karna Pooran and Nasya with Erand Shigruvadi Taila along with Ghritpana in the management of Karna Badhirya w.s.r to Sensorineural Hearing Loss (SNHL)" has been proposed. |