Evaluation of the efficacy of Asanabilwadi taila Karnapoorana, Nasya with Ksheerabala taila 101 avarthi and Narasimha choorna orally in Badhirya- Sensory neural hearing loss- an open-label double arm randomized controlled clinical trial.

Title: Evaluation of the efficacy of Asanabilwadi taila Karnapoorana, Nasya with Ksheerabala taila 101 avarthi and Narasimha choorna orally in Badhirya- Sensory neural hearing loss- an open-label double arm randomized controlled clinical trial.

RESEARCH QUESTION

What is the efficacy of Asanabilwadi Taila Karnapoorana, Nasya with Ksheerabala Taila 101 Avarthi and Narasimha Choorna orally compared with that of Bilwadi Taila Karnapoorana, Nasya with Shadbindu Taila and Sarivadi vati orally for a duration of 45 days in the management of Badhirya - Sensory Neural Hearing Loss?

NULL HYPOTHESIS (Ho)

There is no significant difference between the efficacy of Asanabilwadi Taila Karnapoorana (1 ml in each ear at morning), Nasya with Ksheerabala Taila 101 Avarthi (6 drops in each nostril) and Narasimha Choorna (6 g twice daily) orally in comparison to Bilwadi Taila Karnapoorana (1 ml-at morning), Nasya with Shadbindu Taila (6 drops in each nostril) and *Sarivadi vati (*2 tablets (250 mg) twice daily) orally for a duration of 45 days in Badhirya (sensory neural hearing loss).

ALTERNATE HYPOTHESIS(H1)

There is a significant difference between the efficacy of Asanabilwadi Taila Karnapoorana (1 ml in each ear at morning), Nasya with Ksheerabala Taila 101 Avarthi (6 drops in each nostril), and Narasimha choorna (6 g twice daily) orally in comparison to Bilwadi Taila Karnapoorana (1 ml-at morning), Nasya with Shadbindu Taila (6 drops in each nostril) and *Sarivadi vati (*2 tablets (250 mg) twice daily) orally for a duration of 45 days in Badhirya (sensory neural hearing loss).

Need of the study

A complete or partial loss of hearing in one or both ears is referred to as hearing impairment. Its clinical characteristics are quite similar to those of Badhirya as described in Ayurveda, and it may be congenital or acquired. Three forms of hearing loss are recognized in clinical practice: sensory neural, conductive, and mixed. Conductive hearing loss (CHL) is the term used to describe hearing loss that results from sound conduction from the external ear to the stapediovestibular joint. Sensory neural hearing loss (SNHL) is caused by disorders of the cochlea, vestibulocochlear nerve, and its central connections. Both the conductive hearing loss and sensory neural hearing loss elements are present in mixed hearing loss. Assistive devices, implants, and hearing aids are the most often utilized equipment in the rehabilitation of hearing impairment. However, using these gadgets may be challenging as their users’ perception of sounds is limited compared to individuals with normal hearing. In more severe circumstances where standard hearing aids offer little benefit, a cochlear implant may be an option. The Ayurvedic treatment for hearing impairment can be an alternative to conventional care because the treatment offered by the conventional system of medicine is more expensive and out of the grasp of the average Indian people. So the current studyaims at exploring a cost-effective and safe remedy through Ayurvedic treatment for the management of hearing impairment. Therefore, it is required to find effective treatment measures for the disease.

These factors have been taken into consideration when choosing the study topic for this illness.

AIM To evaluate the efficacy of Karnapoorana with Asanabilwadi taila, Nasya with Ksheerabala taila 101 Avarthi along with Narasimha choorna orally in the management of *Badhirya (*sensory neural hearing loss) in comparison with Bilwadi taila Karnapoorana, Nasya with Shadbindu Taila and Sarivadi Vati orally for a duration of 45 days.

PRIMARY OBJECTIVE

• To evaluate the efficacy of Asanabilwadi Taila Karnapoorana, Nasya with Ksheerabala Taila 101 Avarthi and Narasimha Choorna orally in improving the air conduction thresholds in patients presenting withhearing loss in the range of 26-60 dB based on pure tone average.

SECONDARY OBJECTIVES

• To evaluate the efficacy of Asanabilwadi Taila Karnapoorana, Nasya with Ksheerabala Taila 101 Avarthi and Narasimha Choorna orally in associated symptoms of Badhirya like, Karnanada (Tinnitus) and Bhrama (giddiness).
• To evaluate the physicochemical and organoleptic properties of Asanabilwadi taila, Ksheerabala taila 101 Avarthi, and Narasimha Choorna.

TYPE OF STUDY DESIGN Open labelled double arm randomized controlled clinical trial

Group 1- Intervention with Asanabilwadi taila Karnapoorana, Nasya with Ksheerabala  Taila 101 Avarthi, and Narasimha choornaorally.

Group 2- Control with Bilwadi taila Karnapoorana, Nasya with *Shadbindu Taila,*and Sarivadi Vati orally

STUDY SETTING:

Department of Shalakya Tantra of AIIA, Sarita Vihar, New Delhi

STUDY POPULATION:

Patients attending the OPD and IPD of the department of Shalakya Tantra, and those referred from other departments of All India Institute of Ayurveda, New Delhi, shall be selected irrespective of gender, religion, race, occupation, etc. based on the diagnostic, selection criteria and be enrolled in the study.

Sample size - 20 in each group

INCLUSION CRITERIA

1. Patients having signs and symptoms of Badhirya (SNHL) with mild (26-40 dB) to moderate  (41-60 dB) hearing loss will be selected.

2. Patients of either sex aged between 18 to 60 years.

3. The patient is willing and able to participate in the study.

4. Patients fit for Nasya Karma.

5. Patients fit for Karnapoorana karma.

6. Patients with intact tympanic membrane.

EXCLUSION CRITERIA

1. Conductive & mixed hearing loss

2. Subjects associated with tympanic membrane perforation.

3. Patients with a degree of hearing impairment (>61 dB).

4. Patients with otorrhoea.

5. Pregnant women

6. Patients with congenital hearing loss.

7. Patients who require otological surgical intervention.

8. Malignancy related to the external, middle, and internal ear.

9. Patients with systemic illnesses like DM, Hypertension, Tuberculosis…etc.

10.Patients who are using hearing aid.

ASSESSMENT CRITERIA**-**

Diagnosis will be made according to the Ayurveda and modern subjective and objective parameters.

Subjective Parameters

1. Badhirya – Hearing impairment

2. Karnanada-Tinnitus

3. Bhrama- Vertigo Objective Parameters

4. Tuning fork tests

5. Otoscopy

6. Pure tone Audiometry

7. Tympanometry

These tests are performed to rule out cases of Badhirya (SNHL).

Routine ear examinations will be carried out before and after treatment.

DIAGNOSTIC CRITERIA

Badhirya (SNHL)will be assessed by using the WHO hearing loss grading scale based on Pure Tone Audiometry.

WHO hearing loss grading scale[25]

Grade of impairment

Corresponding audiometric ISO value

Performance

|

0: no impairment

25 dB or better

No or very slight hearing problems. Able to hear whispers

|1: slight impairment

26–40 dB

Able to hear and repeat words spoken in normal voice at 1 m

|2: moderate impairment

41–60 dB

Able to hear and repeat words using raised voice at 1 m

|3: severe impairment

61–80 dB

Able to hear some words when shouted into better ear

|4: profound impairment including deafness

81 dB or greater

Unable to hear and understand even a shouted voice

|

DURATION OF TRIAL:

The duration of the trial will be 45 days.

FOLLOW UP:

·      After completion of 45 days of intervention, the patient will be followed for 21 days.

·     Follow-up of the patients will be ensured by telephonic communication or by creating a WhatsApp group. The compliance of the patient will be noted in a separate sheet provided to them.

ASSESSMENT TIME:

Before treatment, the 15th day, the 30th day, and 45th day

Follow-up on the 7th  day and 21st day.

TOTAL DURATION OF TRIAL :

66 days including follow-up.

INVESTIGATIONS

Following laboratory investigations will be carried out before treatment to rule out any systemic illness, 1. Blood -CBC with ESR 2. Biochemical- RBS

PRIMARY ENDPOINT

Improvement of air conduction thresholds in patients presenting withhearing loss in the range of 26-60 dB based on pure tone average.

SECONDARY ENDPOINT

1. Improvement in associated symptoms of Badhirya (SNHL) like Karnanada (Tinnitus)and Bhrama(Giddiness)

2. The study will provide physicochemical and organoleptic properties of Asanabilwadi taila, Ksheerabala taila 101 Avarthi, and Narasimha Choorna.