| CTRI Number |
CTRI/2024/03/064699 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on Efficacy and Safety of Insufflation with Unani Formulation in The Management of Otomycosis. |
|
Scientific Title of Study
|
Clinical Study on Efficacy and Safety of Nufookh with Unani Formulation in The Management of Otomycosis. A Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Hammad Athar Ansari |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College And Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya
Pradesh
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9770749994 |
| Fax |
|
| Email |
atharhammad9994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arif Anees |
| Designation |
Associate Professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College And Hospital |
| Address |
Department of Ilaj Bit Tadbeer, Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7354297786 |
| Fax |
|
| Email |
arifanees110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Hammad Athar Ansari |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College And Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya
Pradesh
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9770749994 |
| Fax |
|
| Email |
atharhammad9994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya
Pradesh |
| 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 |
| Dr Mohd Hammad Athar Ansari |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No.7 Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road
Bhopal Madhya
Pradesh 462003
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
9770749994
atharhammad9994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H619||Disorder of external ear, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clotrimazole ear drop |
2 drops of Clotrimazole ear drop three times in a day for 15 days.
|
| Intervention |
Nufookh |
Nufookh is the process in which a grounded & filtered drug blown into the patients nose, throat or any other opening of the body through a tube.
Four sittings of Nufookh (drug blown into the Ear) with Unani formulation (Shib e yamani ‘Potassium Aluminium Sulphate’& Lodh pathani ‘Symplocos Racemosa’ ) in External Audiitory Canal of affected ear on 0 day, 5th day, 10th day & 15th day. The dose of the Nufookh drug will be 250mg to 500mg depending upon the size of the ear canal. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed patient of Otomycosis
2.All gender are included |
|
| ExclusionCriteria |
| Details |
1.Patients with any serious debilitating diseases like malignancies, tuberculosis, and other chronic granulomatous diseases.
2.Patients with immune-compromised conditions and history suggestive of fungal diseases elsewhere in the body and those on topical antifungal drops will be excluded from the study.
3.Patient suffering from any other aural pathology e.g. Chronic Suppurative Otitis Media (CSOM), Acute Suppurative Otitis Media (ASOM), Perforation of tympanic membrane, etc. will be excluded from
the study.
4.Patient who refused to give their consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Clinical sign and symptoms
2.Clinical examination |
baseline, 5th, 10th, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Post treatment examination (Smear examination by 10%KOH preparation of ear & Fungal culture of ear will be done on 30th day. |
30th day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2 |
|
Date of First Enrollment (India)
|
17/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Otomycosis is the fungal infection of the external ear. It is characterized by pain, itching, discharge, ear blockage, hearing loss and ringing in ear. Water entry in ear, scratching of the ear etc. produce favourable atmosphere for fungus. Fungus lodges in that area and starts growing and produces these symptoms. Sign of the Otomycosis is whitish, blackish or brownish fungus in ear. Sometimes wet blotting paper appearance also seen.Tragus tenderness and erythema are also the signs of Otomycosis. In rare cases, primarily in immuno-compromised individuals, the disease may be extensive and involve the temporal bone. Otomycosis is commonly seen in hot and humid climate. The term Otomycosis as a disease is not mentioned in Unani classical literatures , but the some clinical features of Otomycosis are described under the headings of Wajaul uzn ,Warme uzn, Dard gosh and Sailanul nuzn in Unani classical literature. The eminent Unani physicians like Shekh-ur-Rais Ibne Sena, Zakariya Razi and Ahmad al Hasan Aljurjani have mentioned different formulations of Nufookh in the management of various ear diseases. Nufookh is the process in which a grounded & filtered drug blown into the patient’s nose, throat or any other opening of the body through a tube. Treatment consists of thorough ear toilet to remove all discharge and epithelial debris which are conducive to the growth of fungus. It can be done by syringing, suction or mopping. broadspectrum antifungal agents include clotrimazole can be applied. Antifungal treatment should be continued for a week even after apparent cure to avoid recurrences 3 . Nufookh therapy with Unani formulation can be done. Ear must be kept clean and dry |