| CTRI Number |
CTRI/2025/04/085832 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ayurvedic management in sensoneural Hearing Loss |
|
Scientific Title of Study
|
Comparative clinical study on the efficacy of Karnapooran and Nasya with Eranda Shigruvadi Taila along with Ghritpana in the management of Karna Badhirya with special reference to Sensorineural Hearing Loss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta mittal |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Government Ayurvedic medical college Budh murti kadamkuan patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7783092350 |
| Fax |
|
| Email |
drmamtania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrawan kumar Gupta |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Government Ayurvedic medical college Budh murti kadamkuan patna Bihar 800003
BIHAR
800003
India |
| Phone |
87574 93735 |
| Fax |
|
| Email |
drshrawangupta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta mittal |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Government Ayurvedic medical college Budh murti kadamkuan patna Bihar 800003
BIHAR
800003
India |
| Phone |
7783092350 |
| Fax |
|
| Email |
drmamtania@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayurvedic college Health department |
| Address |
Government Ayurvedic medical college kadamkuan |
| 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 Shrawan kumar Gupta |
Government Ayurvedic college |
Shalakya Department Room no 3
Kadamkuan Budhmurti Bihar 800003
Patna
BIHAR |
8757493735
drshrawangupta75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H904||Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side. Ayurveda Condition: BADHIRYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hrudya Uttartantra chapter 18 /23-24, Procedure details: ErandaShigruvadi Tail for 7 days followed by a gap of 7 days total 3 sittings)
(1) Medicine Name: Go ghrut, Reference: Sushrut uttartantra chapter 21 /2-3, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 35 Days | | 2 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Ashtang Hrudya Uttartantra chapter 18 /23-24, Procedure details: Karnapooran with ErandaShigruvadi Tail for 7 days followed by a gap of 7 days total 3 sittings))
(1) Medicine Name: Go ghrut, Reference: Sushrut uttartantra chapter 21 /2-3, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 35 Days |
|
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of the intervention |
2months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
determination of the effect of intervention with
respect to other in general
|
2 months |
|
|
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)
|
07/05/2025 |
| 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="2"
Days="0" |
|
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
|
Ear is considered as one of the navadwars in ayurveda that provide two main functions i.e. hearing (detects and analyzes sound by transduction) and equilibrium (maintain the sense of balance). There are various diseases affecting the ears. Badhirya is one mentioned in ancient text. Acharya Sushrata has mentioned it as a disease entity under 28 Karnarogas, Acharya Charak included it under the 80 nanatmaja vatavikaras, Acharya Vagbhatta has described Badhirya under 25 karnarogas. As per Acharya Sushruta when vata gets lodged in shabdavahasira (voice conducting channels) owing to obstacle imposed (margavarodha) by the vitiated kapha, there is manifestation of the disease called Badhirya. The effected person is unable to hear the voice made in the surrounding partially or completely depending on the intensity of the vitiation of the particulars body humors. Sensorineural hearing loss (SNHL) refers to hearing impairment resulting from organic disorders of cochlea (sensory type) or the auditory nerve (8th nerve) and its central connection in brain stem (neural type). The term retro-cochlear is used when hearing loss is due to lesion of the 8th nerve and central deafness when it is due to lesions of central auditory connections.
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