| CTRI Number |
CTRI/2019/07/020385 [Registered on: 26/07/2019] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to see the effect of ayurvedic oil through topical and nasal route in the management of ringing sound in ears |
|
Scientific Title of Study
|
An Open Labelled Randomized Clinical Trial To Evaluate Asana Bilwadi Taila Shirobasti, Nasya And Karnapoorana In Karnakshweda With Special Reference To Tinnitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Shalakya Tantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandvi Sharma |
| Designation |
Post Graduate Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Shalakya Tantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8818849577 |
| Fax |
|
| Email |
lively18sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandvi Sharma |
| Designation |
Post Graduate Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Shalakya Tantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8818849577 |
| Fax |
|
| Email |
lively18sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jorawar Singh Gate, Amer Road, Jaipur 302002, Rajasthan |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, 302002,Rajasthan, India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shamsa Fiaz |
National Institute of Ayurveda, Jaipur |
ENT OPD, Room number 13,Shalakya Tantra Division,National Institute of Ayurveda, Jorarwar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN |
8764009846
shamsa_fiaz@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda, Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H931||Tinnitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasya and Karnapoorana |
15 patients will be administered Nasya and Karnapoorana with Asana Bilwadi Taila m
Procedure of Nasya: Lukewarm oil drops (the temperature of the oil should be bearable by the patient) will be poured inside the nostrils of the patients.
Dose-6-8drops(3-5ml)
Route-Nasal
Frequency-Once daily for 7 days then gap of 7 days then again once daily for 7 days
Duration- 14 days
Procedure of Karnapoorana: Lukewarm oil (the temperature of the oil should be bearable by the patient) is poured into the patient’s ear canals.
Dose-5-10 ml
Route-Topical
Frequency- Once daily for 7 days then a gap of 7 days then again once daily for 7 days
Duration – 100 matra
|
| Intervention |
Shirobasti |
15 patients will be given Procedure of Shirobasti: A column of oil is allowed to stand on the head with the help of suitable, fitting leather cap, the oil will be reheated every time as soon as it starts to turn cold.
Dose- 1-1.5 Litres
Route- Topical
Frequency- Once daily for 14 days
Duration- Samyaka lakshana obtained/10000matra/53 minutes (approx)
|
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Inclusion Criteria
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| Age From |
8.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
4.Patients having tinnitus ototoxicity induced.
5..Patients having tinnitus associated with sensorineural hearing loss |
|
| ExclusionCriteria |
| Details |
1. Patients aged below eight years and above eighty years will be excluded.
2. Patients presenting with tympanic membrane perforation.
3. Otological surgery within the past year.
4. Patients presenting with congenital deformities
5. Known case of immunodeficiency as in Tuberculosis.
6. Pregnancy.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
Kriyakalpa procedures might be effective in the following conditions:
1.Keshshata(Pattern hair loss)
2.Timira(Refractive errors)
3.Nasa Asya shosha(Dryness of mouth and nose)
4.Stress |
15th day after completion of procedures
30th day after completion of procedures
45th day after completion of procedures. |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
19/09/2019 |
| Date of Study Completion (India) |
30/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
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 account
of Karnakshweda as a Swantantra Roga and Lakshana is found
in the classics of Ayurveda.
2. Tinnitus is the closest
modern counterpart of Karnakshweda and these are disorders of CNS and
auditory nerve origin.
3. Tinnitus has worldwide
prevalence and can affect a person of any gender belonging to any age-groupage
no.
4. Tinnitus can be very
intrusive and may cause difficulty with sleep and concentration and a decreased
ability to participate in everyday activities and social events.
5. With growing levels of
stress and noise pollution the incidences of tinnitus are also increasing.
6. The prevalence was found
more in the people of active nature of work proving that Shrama is an important Nidana in the pathogenesis of Karnakshweda.
7. Majority of the patients
had Vata-Pitta Prakriti which was in
accordance of the Jangala Desha of
the place of study.
8. Most of the patients
i.e. 62.5% patients complained of bilateral tinnitus, it can be said that due
to the Balwana Swabhava of Vyadhi due to Tridosha and Rakta involvement it acquires both the Adhisthanas of Shravanendriya.
9. The study shows that
both the therapies were effective in treating the Lakshanas of Karnakshweda based
on the subjective criteria i.e. for both of the groups p-value<0.05 hence
both treatments were significant but in Group-B Nasya and Karnapoorana
were found to be effective in Badhirya based
on the objective criteria with p-value<0.05 hence considered as significant.
10. On statistical analysis
it was found that there was no
significant difference between both the groups.
11. The finished product
drug analysis proved Asana-Bilwadi Taila
to be safe and non-toxic, the rancidity value was 0 indicating high shelf life
with no microbe growth.
12. No adverse effects or
incidental findings were observed during and after trial.
13. Concisely Ayurveda
modalities and drug proved to be safe and effective in the management of Karnakshweda.
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