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Clinical study to see the effect of ayurvedic oil through topical and nasal route in the management of ringing sound in ears

Phase 2
Completed
Conditions
Tinnitus,
Registration Number
CTRI/2019/07/020385
Lead Sponsor
National Institute of Ayurveda Jaipur
Brief Summary

This was an open labelled randomized trial

Purpose – To Prove the effectiveness of Asana -Bilwadi Taila Shirobasti and Asana-Bilwadi Nasya and Karnapoorana in the management of Karnakshwda w.s.r. (Tinnitus).

**Drug:** *Asana-Bilwadi Taila*

Group A – *Shirobasti*

Total Duration: 14 days and 10,000 *Matra*(53 minutes approx)

Group B- *Nasya & Karnapoorana*

*Nasya*: 6-8 drops

*Karnapoorana*: 10-12 drops in each ear canal

Total Duration: 14 days divided in 2 sittings with 1week gap.

Follow up was taken after completion of therapies on 15th, 30th and 45th day

**CONCLUSIONS:**

1.      A very detailed accountof *Karnakshweda* as a *Swantantra Roga* and *Lakshana* is foundin the classics of Ayurveda.

2.      Tinnitus is the closestmodern counterpart of *Karnakshweda* and these are disorders of CNS andauditory nerve origin.

3.      Tinnitus has worldwideprevalence and can affect a person of any gender belonging to any age-groupageno.

4.      Tinnitus can be veryintrusive and may cause difficulty with sleep and concentration and a decreasedability to participate in everyday activities and social events.

5.      With growing levels ofstress and noise pollution the incidences of tinnitus are also increasing.

6.      The prevalence was foundmore in the people of active nature of work proving that *Shrama* is an important *Nidana* in the pathogenesis of *Karnakshweda*.

7.      Majority of the patientshad *Vata-Pitta Prakriti* which was inaccordance of the *Jangala Desha* ofthe place of study.

8.      Most of the patientsi.e. 62.5% patients complained of bilateral tinnitus, it can be said that dueto the *Balwana Swabhava* of *Vyadhi* due to *Tridosha* and *Rakta* involvementit acquires both the *Adhisthanas* of *Shravanendriya*.

9.      The study shows thatboth the therapies were effective in treating the *Lakshanas* of *Karnakshweda* basedon the subjective criteria i.e. for both of the groups p-value<0.05 henceboth treatments were significant but in Group-B *Nasya* and *Karnapoorana*were found to be effective in *Badhirya* basedon the objective criteria with p-value<0.05 hence considered as significant.

10.  On statistical analysisit was found that there was nosignificant difference between both the groups.

11.  The finished productdrug analysis proved *Asana-Bilwadi Taila*to be safe and non-toxic, the rancidity value was 0 indicating high shelf lifewith no microbe growth.

12.  No adverse effects orincidental findings were observed during and after trial.

13.  Concisely *Ayurveda*modalities and drug proved to be safe and effective in the management of *Karnakshweda*.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 1.Patients presenting with sign and symptoms of Karnakshweda described as per ayurvedic text and modern parlance.
  • 2.Patients having tinnitus due to Otosclerosis.
  • 3.Patients having tinnitus noise induced.
  • 5..Patients having tinnitus associated with sensorineural hearing loss.
Exclusion Criteria
  • Patients aged below eight years and above eighty years will be excluded.
  • Patients presenting with tympanic membrane perforation.
  • Otological surgery within the past year.
  • Patients presenting with congenital deformities 5.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Asana Bilwadi Taila Shirobasti, Nasya and Karnapoorana are effective in the management of Karnakshweda w.s.r.(Tinnitus)15th day after completion of procedures. | 30th day after completion of procedures. | 45th day after completion of procedures.
Secondary Outcome Measures
NameTimeMethod
Kriyakalpa procedures might be effective in the following conditions:1.Keshshata(Pattern hair loss)

Trial Locations

Locations (1)

National Institute of Ayurveda, Jaipur

🇮🇳

Jaipur, RAJASTHAN, India

National Institute of Ayurveda, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr Shamsa Fiaz
Principal investigator
8764009846
shamsa_fiaz@yahoo.com

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