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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | AByantarasnehaH, आà¤à¥à¤¯à¤¨à¥à¤¤à¤°à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Astanga hridaya, Procedure details: Shodanaga snehapana with Tiktaka ghrita till samyaksnigdha lakshana is attained)
| 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Astanga hridaya, Procedure details: 12gms of Avipathy choorna mixed with hot water in morning (empty stomach))
| 3 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Astangahridaya, Procedure details: whole body massage and steam bath)
| 4 | Intervention Arm | Procedure | - | dIpana , दीपन | (Procedure Reference: Astangahridaya chikitsashtana, Procedure details: 5gm Asta choorna mixed with ghee taken along the first bolus of food)
| 5 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanga hridaya, Procedure details: Sirovirechana type of nasya with Sirovirechana gana taila for 5 days after virechana.)
| 6 | Intervention Arm | Procedure | - | karNadhUpanam, करà¥à¤£à¤§à¥‚पनमॠ| (Procedure Reference: Astanga hridaya, Procedure details: karnadhoopana with guggulu varti for 15 days )
| 7 | Intervention Arm | Procedure | - | avacUrNan  , अवचूरà¥à¤£à¤¨Â | (Procedure Reference: Astanga hridaya, Procedure details: Dusting the ear with Samudraphena choorna on alternate days after dry mopping the EAC.)
| 8 | Intervention Arm | Drug | Classical | | (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: - | 9 | Intervention Arm | Drug | Classical | | (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. |