Clinical study to assess the effect of classical management in making wet ear dry in Tubo-Tympanic type CSOM.

Phase 3

Not yet recruiting

Conditions: Central perforation of tympanic membrane. Ayurveda Condition: KARNA-SRAVAH,

Registration Number: CTRI/2022/01/039742

Lead Sponsor: Amrita school of Ayurveda

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 individualâ€™s quality of life to a great extent â€“ 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 guggulucan 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients of either sex and age between 20 to 60 years.
Patients with signs and symptoms of CSOM fulfilling the diagnostic criteria.

Exclusion Criteria

Patients contraindicated to Nasya.
Attico-antral/ squamous CSOM with complications.
CSOM associated with any systemic disorders.
Any other ear pathology with and without discharge.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Amrita School Of Ayurveda
🇮🇳
Kollam, KERALA, India
Amrita School Of Ayurveda
🇮🇳Kollam, KERALA, India
DrAnjithSS
Principal investigator
8281547402
anjith4892@gmail.com