| CTRI Number |
CTRI/2020/02/023090 [Registered on: 03/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
STUDY OF KARNA NAAD ( TINITUES ) BY APAMARGAKSHAR TAILA KARNAPOORANA AND GOGHRITA PAANA (ORALY )
|
|
Scientific Title of Study
|
“A CLINICAL STUDY OF APAMARGAKSHARA TAILA KARANPOORANA AND GOGHRITA PAANA IN THE MANAGEMENT OF KARAN NAAD W.S.R. 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 Pramod Tukaram Borghare |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to Be University College of Ayurveda and Hospital Dhankawadi Katraj Pune Maharashtra 411043 India
Pune
MAHARASHTRA
411043
India |
| Phone |
9881225532 |
| Fax |
|
| Email |
drpramodborghare@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Kadam |
| Designation |
Head of the Department and Professor |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to Be University College of Ayurveda and Hospital Dhankawadi Katraj Pune Maharashtra 411043 India
Pune
MAHARASHTRA
411043
India |
| Phone |
9850704820 |
| Fax |
|
| Email |
dr.kadam66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Diwan |
| Designation |
Associate Professor |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to Be University College of Ayurveda and Hospital Dhankawadi Katraj Pune Maharashtra 411043 India
Pune
MAHARASHTRA
411043
India |
| Phone |
9822284347 |
| Fax |
|
| Email |
pramod_diwan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra Bharati Vidyapeeth deemed to be university college of Ayurveda dhankawadi pune 411043
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical Foundation Ayurveda Hospital Pune |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurveda Dhankawadi Pune Department of Shalakya Tantra OPD NO 27 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pramod Borghare |
BHARATI VIDYAPEETH COLLEGE OF AYURVED PUNE |
Bharati Vidyapeeth College of Ayurved and Hospital Dhankawadi, Pune 411003, Department of shalakya Tantra (ENT) OPD no. 27
Pune
MAHARASHTRA |
9881225532
drpramodborghare@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDU Ccollege of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H931||Tinnitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karnapoorna with Apamargkshar Tail & Goghrita paana ( Oral ) |
Apamargkshar Tail, 2ml each ear 2 Time in a day , Karnapoorna 300 Matra Uccharan Kaal (10Min.) & Goghrita paana every day 10gm 2 times in day with Ushna Jala.2 months (60 Days) Follow up 1 month after Tretment Total 90 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with symptoms of Karna naad irrespective of gender, caste and religion.
2.Patients in the age group of 25 to 75 years with intact Tympanic Membrane. |
|
| ExclusionCriteria |
| Details |
1.Congenital Deformity. (Related to ear)
2.Perforation of Tympanic membrane.
3.Patient of Otosclerosis and fluid in the middle ear.
4.Blockage due to stenosis of external auditory canal/wax.
5.Pregnant, immune compromised patients.
6.Tinnitus due to non Otologic factors (Diabetes mellitus, Hypertension, Thyroid disease etc.) and glomus tumors, aneurysm of carotid artery, palatal myoclonus and tumors of auditory nerve.
7.Patients not willing to be registered for the trial.
8.Cases which required surgical intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients relieve from all sign and symptoms with the help of (Tinnitus Severity Index Questionnaire)
Hematology: Hb%, TC, DC, ESR
2. Otoscopy.
3. Tuning fork test.
4. Audiometry.
(clinical examination ) |
60 days(3 follow ups of every 15 days duration) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patients relieve from all sign and symptoms with the help of (Tinnitus Severity Index Questionnaire)
Hematology: Hb%, TC, DC, ESR
2. Otoscopy.
3. Tuning fork test.
4. Audiometry.
(clinical examination ) |
Assessment to Recurance Folloe up 1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2020 |
| 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="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Karna naad which happens when Vata gets localized in the siras or channels which convey sounds. The sounds may vary and may be constant or intermittent. If left untreated, it may gradually give rise to hearing difficulties even for loud sounds and ultimately leads to deafness.
The prevalence of tinnitus in adults with hearing problems is very high (59 to 86%), and it is estimated that tinnitus is present in 50% of patients with sudden hearing loss, 70% with Presbycusis, and 50 to 90% with noise-induced hearing loss.The prevalence of tinnitus increases significantly with aging, but people of all ages experience tinnitus. Tinnitus is also experienced by those with normal hearing; 18% of tinnitus patients were reported to have normal hearing. Karnapoorana; - Karna being one of the Adhisthana of Vata- Dosha, Snehana becomes important to control the localized Increased Vata Dosha. Hence, Karnapoorana gains importance in the management of Karan naad Vata predominant diseases.The ingratents of apamargkshar tail are murchit sesame oil, water , apamargkshar and apamarg. To preper properly medicatet oil murchit sessarm oil mejuring 1 letter , water treted with apamarkshar mejuring 4 latter and kalka of apamarg mejuring 250gm should be taken this. oil is used in karnanad (Noice inside the ear) and deffenss. Goghrita pana- Goghrita having property “Samskarasya Anuvartanatva†When processed with Vatashamaka drugs and having Rasayana Guna becomes the best line of treatment for Karna naad. Hence Goghrita Paana was selected. Karan naad is a Madhyama marga gata Vata Vyadhi in which Prakupita Vata dosha settles in Shabdavaha Shrotas as a result of Vimargagamana. Hence the drugs need to have Vatahara properties in order to normalize vitiated vata dosha. Snehana is described as an important procedure in treatment of vata dosha. Apamargkshar Taila is used for snehana in the form of karnapoorana. Apamargkshar Taila mainly contains ushna virya (65.78%) drugs and til taila is its main ingredient which is considered best for treatment of vata. Til Taila is an essential analgesic and useful for wound healing, skin, ear, dental and hair problems, useful in dryness by acting as Vatashamak. Local application of oil pack in ear reduces pain. No. Of Patients Total :- 60 Singal Group Treated with Apamargkshar tail and goghritpaana, 2 m Months with 1 months folloup ( Assessment :- Day1 befor tretment , day 15 , day 30, day 45, day 60 last folloup after tretment Recurance Folloup up 1 month)
|