| CTRI Number |
CTRI/2025/04/084448 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Running nose manage with steam inhalation. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial-Assessing the Efficacy of
Medicated and Non-Medicated Inkibäb (Steam Inhalation) with Atus (Errhine
therapy) in the Management of Waram Tajäwif al-Anf Muzmin (Chronic Sinusitis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Madiha Anjum |
| Designation |
PG scholar |
| Affiliation |
Government Unani Medical College |
| Address |
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7708421967 |
| Fax |
|
| Email |
drmadihaanjum98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nizamudeen |
| Designation |
Associate professor |
| Affiliation |
Government Unani Medical College |
| Address |
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8754404152 |
| Fax |
|
| Email |
drnizamgumc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nizamudeen |
| Designation |
Associate professor |
| Affiliation |
Government Unani Medical College |
| Address |
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
Government Unani Medical College,
PG IBT OPD,
Room No: 103,
Anna Hospital Campus, P.H.Road, Arumbakkkam, Chennai
TAMIL NADU
600106
India |
| Phone |
8754404152 |
| Fax |
|
| Email |
drnizamgumc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College, Chennai.
Tamilnadu, India.
Pin: 600106 |
|
|
Primary Sponsor
|
| Name |
Dr Madiha Anjum |
| Address |
Government Unani Medical College, Anna Hospital Campus, Arumbakkkam,Chennnai 600106 |
| 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 Madiha Anjum |
Arignar Anna Hospital |
Arignar Anna Hospital, Government Unani Medical College, Arumbakkam, Chennai - 600106.
Chennai
TAMIL NADU |
7708421967
drmadihaanjum98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethicas Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medicated Inkibab (Medicated Steam Inhalation) With Atus (Errhine Therapy) |
Steam inhalation with the decoction of Gul E Baboona NAKHOONA, TUKHM E SHIBIT, and SATAR followed by ATUS (errhine therapy) with the drug IRSA. |
| Comparator Agent |
Steam Inhalation with Plain
Water Followed by Atus (ERRHINE THERAPY) |
Steam Inhalation with Plain
Water followed by ATUS (ERRHINE THERAPY) with the drug IRSA (IRIS INSTATA) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
Both gender
Patient Present with the complaints of chronic sinusitis
Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
Below 18 year and above 60 year
Mentally retarded person
A patient who had congenital abnormality of the nasal cavity
Not willing to give concern
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of two unani intervention therapy assessed by using VAS scale for facial Pain and VAS score for improving the overall severity of symptoms (subjective parameter). |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SNOT 22 Quality of life scale |
35 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
05/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A Randomized Comparative Clinical Trial- Assessing the efficacy of Medicated and Non-Medicated inkibaba (steam Inhalation) with atus (Errhine therapy) in the Management of waram tajawif al anaf muzmin (Chronic Sinusitis). Chronic sinusitis is characterised by nasal symptoms of sinus inflammation lasting for more than 12 weeks. It is 2 types: with nasal polyps and without polyps. The Infectious Disease of America (IDSA) states that the symptoms of sinusitis is out of any three symptoms include purulent discharge, nasal congestion or nasal blockage, facial pain or pressure, hyposmia, and anosmia. In unani waram tajawif al anf muzmin (WTA), it is caused by external cold, sudda (blockage), and ufunat (infection); hence it is considered a waram tajawif al anaf muzmin. In this study, an attempt is made to evaluate the effectiveness of inkibab (Medicated steam inhalation ) with atus (Errhine therapy ) in the management of waram tajawif al anaf muzmin. The main aim of the study was to compare the effectiveness of two unani intervention, inkibab (steam inhalation) with medicated herbal decoction containing gul e babuna, nakhuna, tukhm shibbit, satar (6gm each) to be boiled in four cups of water (1000ml) with a closed lid for a few minutes and other with only plain water stem inhalation followed by atus (errhine therapy) with the drug of irsa (iris ensata) in the management of warm e tajawif anaf muzmin. The trial is conducted for comparative analysis of medicated steam inhalation and only plain water inhalation, followed by errhine therapy (snuff) in the management of chronic sinusitis. Therapy will be given for 5 weeks at OPD and IPD of PG Department of IBT, Arignar Anna Government Hospital of Indian Medicine attached with Government Unani Medical College (GUMC), Chennai-600 106. The patients will be asked to have a regular follow-up in the OPD weekly. Every week, the clinical assessment will be recorded in the prescribed pro forma. The laboratory investigation will be done before and after treatment and will be received in the prescribed format.
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