Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2018/06/014538 |
Date of registration:
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15-06-2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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AYURVEDIK MANAGEMENT OF PUS DISCHARGE FROM EAR (OTITIS MEDIA) WITH MEDICATED NASAL DRPOS AND MEDICATED EAR FUMIGATION
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Scientific title:
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A CLINICO COMPARATIVE STUDY OF SHIROVIRECHANA PURVAKA KARNADHUPANA AND KARNADHUPANA ALONG WITH PATOLADI KWATHA IN THE MANAGEMENT OF KARNASRAVA (OTITIS MEDIA) |
Date of first enrolment:
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18-06-2018 |
Target sample size:
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30 |
Recruitment status: |
Not Yet Recruiting |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=26641 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group Trial Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Khushbu Vipul Vyas
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Address:
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Room no 10 Government Akhandananda ayurveda collage Bhadra Ahmedabad
380001
Ahmadabad, GUJARAT
India |
Telephone:
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9427410171 |
Email:
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drkrishna1111@gmail.com |
Affiliation:
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Government Akhandananda Ayurveda collage Ahmedabad |
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Name:
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Dr Krishna J Makadia
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Address:
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Room No. 10 Goverment Akhandananda ayurveda collage
Lal darwaja
Ahmedabad
380001
Ahmadabad, GUJARAT
India |
Telephone:
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9427410171 |
Email:
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drkrishna1111@gmail.com |
Affiliation:
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Government Akhandananda Ayurveda collage Ahmedabad |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who are fulfilling the diagnostic criteria based on sign and symptoms of Karnasrava and indicated for shirovirechana will be selected.
Exclusion criteria: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- patient suffering from Karnasrava(Otitis Media)
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Intervention(s)
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Intervention1: 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 . Control Intervention1: 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.
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Primary Outcome(s)
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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.Timepoint: 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.
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Secondary Outcome(s)
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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.Timepoint: 37 days
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Source(s) of Monetary Support
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Government Akhandananda Ayurveda Collage, Bhadra, Ahmedabad
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Ethics review
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Status: Approved
Approval date: 12/07/2017
Contact:
Institutional Ethical Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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