| CTRI Number |
CTRI/2018/06/014538 [Registered on: 15/06/2018] Trial Registered Prospectively |
| Last Modified On: |
14/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIK MANAGEMENT OF PUS DISCHARGE FROM EAR (OTITIS MEDIA) WITH MEDICATED NASAL DRPOS AND MEDICATED EAR FUMIGATION |
|
Scientific Title of Study
|
A CLINICO COMPARATIVE STUDY OF SHIROVIRECHANA PURVAKA KARNADHUPANA AND KARNADHUPANA ALONG WITH PATOLADI KWATHA IN THE MANAGEMENT OF KARNASRAVA (OTITIS MEDIA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu Vipul Vyas |
| Designation |
MS Scholar |
| Affiliation |
Government Akhandananda Ayurveda collage Ahmedabad |
| Address |
Room no 10 Government Akhandananda ayurveda collage Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
7405140511 |
| Fax |
0 |
| Email |
kvvyas93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna J Makadia |
| Designation |
Reader Shalakya tantra Department Government Akhandananda ayurveda collage Bhadra Ahmedabad |
| Affiliation |
Government Akhandananda Ayurveda collage Ahmedabad |
| Address |
Room No. 10 Goverment Akhandananda ayurveda collage
Lal darwaja
Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9427410171 |
| Fax |
0 |
| Email |
drkrishna1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushbu Vipul Vyas |
| Designation |
MS Scholar |
| Affiliation |
Government Akhandananda Ayurveda collage Ahmedabad |
| Address |
Room no 10 Government Akhandananda ayurveda collage Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
7405140511 |
| Fax |
0 |
| Email |
kvvyas93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandananda Ayurveda Collage, Bhadra, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government Akhandananda Ayurveda Collage |
| Address |
Government Akhandananda Ayurveda Collage Bhadra Ahmedabad |
| 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 |
| Khushbu Vipul Vyas |
Govt. Akhandananada Ayrveda Collage |
Room no 10 (Shalakyatantra Dept.)
Ahmadabad
GUJARAT |
7405140511
0
kvvyas93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient suffering from Karnasrava(Otitis Media), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Management of Karnasrava (Otitis Media) with Karnadhupana and Patoladi kwatha pana. |
15 patients will be taken in Group A and will be treated with Karnadhupana by vacha and nimba for 5-20 minute- once in a day and 20 ml Patoladi kwatha will be given twie in a day at jirnanna kala for 10 days. After that for 20 days only40 ml Patoladi kwatha, twice in a day, jirnanna kale will be given. |
| Intervention |
Management of Karnasrava (Otitis Media) with Shirovirechana purvaka Karnadhupana and Patoladi kwatha pana. |
15 patients will be taken in Group B and will be treated with Shirovirechana nasya by Sarshapa taila in dose of 6-6 drops in each nostril - once in a day at morning , for 7 days .Then Karnadhupana will be given by vacha and nimba for 5-20 minute- once in a day and 20 ml Patoladi kwatha will be given twie in a day at jirnanna kala for 10 days. After that for 20 days only 20 ml Patoladi kwatha will be given, twice in a day at jirnanna kala . |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are fulfilling the diagnostic criteria based on sign and symptoms of Karnasrava and indicated for shirovirechana will be selected. |
|
| ExclusionCriteria |
| Details |
Malignenecy, HIV, etc.and Patients having disease like Otitis Media, Eczematous Otitis Externa, Furunculosis in ear,Fungal infection, Granuloma,Polyp in ear,First and Second stage of A.O.M. and attico antral type of C.S.O.M. will be excluded. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of Karnasrava will be assigned score depending upon their severity to assess the effect of the drugs at the time, before and after the treatment. |
All the signs and symptoms of Karnasrava will be assigned score depending upon their severity to assess the effect of the drugs at the time, before and after the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of Karnasrava will be assigned score depending upon their severity to assess the effect of the drugs at the time, before and after the treatment. |
37 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2018 |
| 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="8"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study is to compair the efficacy of Shirovirechana purvaka Karnadhupana and Karnadhupana, along with Patoladi Kwatha in management of Karnasrava(Otitis Media). The study is randomized and patient selection will be blinded. Shirovirechana will be given for 7 days acconding to shashtrokta procedure and Karnadhupana will be given for 10 days and karnadhupana yantra will be made for that. Patoladi kwatha will be given for 30 days for shamana purpose. |