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CTRI Number  CTRI/2022/01/039742 [Registered on: 27/01/2022] Trial Registered Prospectively
Last Modified On: 26/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Clinical study to assess the effect of classical management in making wet ear dry in Tubo-Tympanic type CSOM. 
Scientific Title of Study   Clinical study to assess the effect of Shirovirechana, Gugguludhoopana and Samudraphenaavachoornana in Managing Ear Discharge of Tubo-Tympanic type CSOM 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AnjithSS 
Designation  PG Scholar 
Affiliation  Amrita school of Ayurveda 
Address  Department of Shalakyatantra. Amrita School Of Ayurveda. Clappana.P.O.

Kollam
KERALA
690525
India 
Phone  8281547402  
Fax    
Email  anjith4892@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashwini B N 
Designation  Associate Professor 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Shalakyatantra. Amrita School Of Ayurveda. Clappana.P.O.

Kollam
KERALA
690525
India 
Phone  7025867095  
Fax    
Email  drashwinibelludi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Sivabalaji 
Designation  Associate Professor 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Shalakyatantra. Amrita School Of Ayurveda. Clappana.P.O.

Kollam
KERALA
690525
India 
Phone  7559027947  
Fax    
Email  balajisiva85k@gmail.com  
 
Source of Monetary or Material Support  
Amrita school of Ayurveda clappana.P.O Kollam 
 
Primary Sponsor  
Name  Amrita school of Ayurveda 
Address  Amrita school of Ayurveda clappana.P.O Kollam 690525 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnjithSS  Amrita School Of Ayurveda  Amrita School Of Ayurveda Department of Shalakya tantra Vallikavu, Clappana.P.O Kollam-690525
Kollam
KERALA 
8281547402

anjith4892@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Institute of Medical Sciences Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H720||Central perforation of tympanic membrane. Ayurveda Condition: KARNA-SRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AByantarasnehaH, आभ्यन्तरस्नेहः (Procedure Reference: Astanga hridaya, Procedure details: Shodanaga snehapana with Tiktaka ghrita till samyaksnigdha lakshana is attained)
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Astanga hridaya, Procedure details: 12gms of Avipathy choorna mixed with hot water in morning (empty stomach))
3Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Astangahridaya, Procedure details: whole body massage and steam bath)
4Intervention ArmProcedure-dIpana , दीपन (Procedure Reference: Astangahridaya chikitsashtana, Procedure details: 5gm Asta choorna mixed with ghee taken along the first bolus of food)
5Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Astanga hridaya, Procedure details: Sirovirechana type of nasya with Sirovirechana gana taila for 5 days after virechana.)
6Intervention ArmProcedure-karNadhUpanam, कर्णधूपनम् (Procedure Reference: Astanga hridaya, Procedure details: karnadhoopana with guggulu varti for 15 days )
7Intervention ArmProcedure-avacUrNan  , अवचूर्णन  (Procedure Reference: Astanga hridaya, Procedure details: Dusting the ear with Samudraphena choorna on alternate days after dry mopping the EAC.)
8Intervention ArmDrugClassical(1) Medicine Name: Tiktaka kashayam, Reference: Astanga hridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
9Intervention ArmDrugClassical(1) Medicine Name: Kaisoora guggulu, Reference: Sarangadhara samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex and age between 20 to 60 years.
Patients with signs and symptoms of CSOM fulfilling the diagnostic criteria.  
 
ExclusionCriteria 
Details  Patients contraindicated to Nasya.
Attico-antral/ squamous CSOM with complications.
CSOM associated with any systemic disorders.
Any other ear pathology with and without discharge.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO assess the effect of Sirovirechana, gugguludhoopana and samudraphenavachoornana in managing eardischarge of Tubo-Tympanic CSOM.  Aural endoscopic pictures at the time of screening and end of the treatment trail.
Assessment of sujective parameters at screening, after treatment and each followup on 45th, 60th, 75th and 90th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of classical methods in making active ear inactive.  Follow up once in 15days for a period of 2 months to assess the sustained effect treatment. 
 
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   Phase 3 
Date of First Enrollment (India)   01/02/2022 
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="9"
Days="0" 
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)?  

Response - NO
Brief Summary  

Chronic suppurative otitis media is long-standing infection of a part or whole of the middle ear cleft characterized by ear discharge. Aural toilet, ear drops, systemic antibiotics, surgical management (Myringoplasty / Tympanoplasty) have been the choice of treatment for chronic suppurative otitis media. Complications of surgery include bleeding, damage to the inner ear if stapes is accidentally removed, and injury to facial nerve, damage to sigmoid sinus if the mastoid is also exposed, meninges may be damaged and failure of graft may occur. Surgery is necessary for the definitive management of CSOM, and there is a need to convert wet ear into dry ear for good surgical outcomes. In addition, otorrhoea may become a complication of many surgical procedures such as tympanoplasty, myringoplasty and mastoidectomy. For these reasons, many ototopical antimicrobial with or without steroids are widely used for the treatment of otorrhoea in patients with CSOM. Long term usage of antimicrobial ear drops will lead to resistance of organism. Some ear drops are even potentially ototoxic. In spite of above management, this disease can persist lifelong and hamper an individual’s quality of life to a great extent – in Physical, mental, emotional and social functioning. Converting the wet ear into dry is crucial for good surgical outcome also. Hence, the present study is planned to make active ear into inactive and to achieve clinical cure by making the ear dry.

 In Ayurveda, Acharya Sushruta describes Karna srava, a disease characterized by ear discharge. Specific nidanas are explained i.e. shiroabhighata and jala namanjana. Treatment line is sirovirechana, dhavana, pramarjana and dhoopana. In Ashtanga hridaya, Vagbhata explains dusta vrana chikitsa.

In this study, Kayavirechana will be done first to eliminate the doshas present in koshta; then sirovirechana will be done with sirovirechana gana to eliminate the doshas lodged in jatrurdhwa. Guggulu varti will be used for karna dhoopana as guugulu have properties like sothahara, vranaropana, kaphasaraka and is also indicated for karna dhoopana. Samudra phena choorna will be used for karna avachoornana as described by Yogaratanakara. Samudra phena has kashaya rasa, sheeta veerya and srava hara property can help to arrest the discharge. Internally, tikitaka kashaya will be administered. It is mentioned in dusta vrana chikitsa and has ingredients like patola, nimba, katuka, darvi, which have kaphaghna, vranasodhana, vranaroopana and krimighna like qualities which is beneficial in reducing the srava. Kaishora guggulu can be administered along with kashaya, mentioned in sarangadhara madhyama khanda and has ingredients like triphala, guduchi, vidanga, darvi, guggulu, which have tridoshaghana, vranasodhana, vranaroopana, krimighna like properties and will give added benefits to kashaya.

Aural endoscopic pictures taken during screening, after treatment and on each  follow up to assess the effectiveness of the intervention.

 

 
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