| CTRI Number |
CTRI/2024/10/075936 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of sinusitis with the help of aromatherapy |
|
Scientific Title of Study
|
An observational study on Chronic Sinusitis (Waram-tajaweef al-anf muzmin) and theurapetic evaluation of aromatherapy (shamoom) in its management
|
| 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 Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology. Department: Centre for AYUSH Sciences Division: Ayush health and wellness centre, OPD no:1
Pulwama JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Division: Ayush health and wellness centre, OPD no:1
JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology. Department: Centre for AYUSH Sciences,Division: Ayush health and wellness centre, OPD no:1
JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
|
Source of Monetary or Material Support
|
| Islamic University of Science and Technology, Awantipora, Pulwama, Jammu & Kashmir. 192122.India |
|
|
Primary Sponsor
|
| Name |
Islamic University of Science and technology |
| Address |
Islamic University of Science and Technology, Awantipora, Pulwama 192122, Jammu & Kashmir. |
| Type of Sponsor |
Research institution |
|
|
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 Tabasum Fatima |
AYUSH Health and Wellness Centre |
Islamic University of Scienec and technology, Department-Centre for AYUSH Science, Ayush Health and Wellness Centre, Moalijat OPD, Room no 1. Pulwama JAMMU & KASHMIR |
9419421375
tabasumfatima281@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Islamic University of Science and technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
polyherbal formulation comprising of Pudina (Menthaspicata L.), Ajwain(PtychotisAjowan), Ustukhudus (Prunella Vulgaris), Marzanjosh (OriganumMajorana) and Guletesu (Butea Frondosa) |
the drugs will be added in water and then steam inhalation will be given at bed time for 15 minutes daily for 45 days with follow up as on the 15th, 30th,45th day. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed patients of Sinusitis with headache, nasal obstruction, running nose, malaise, hyposmia
2.Irrespective of all genders.
3.Patient’s between15-60 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 15 and above 60 years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients with history of Cardiovascular, Endocrine, Renal and Liver diseases
5.Patients with COPD, Asthma and any severe lung disease
6.Pregnancy, Lactation, Patients on Oral Contraceptives.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| X- Ray Para nasal Sinuses |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SNOT 22 |
2 years |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tabasumfatim281@gmail.com].
- For how long will this data be available start date provided 05-07-2025 and end date provided 07-07-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
WaramTajäwéf al-AnfMuzmin (Chronic Sinusitis) is the
chronic inflammation of para nasal sinuses which affects all people
worldwide.Symptoms and signs of NazlaBäridMuzmin have been described in details
in of Unani literature which closely resemble the symptoms of chronic sinusitis,
although IltihäbTajäwéf al-Anf or WaramTajäwéf al-Anf (Sinusitis) has not been
mentioned as a disease in literature of Unani Medicine.(1,2,3,4)
Therefore, NazlaBäridMuzmin has been considered as WaramTajäwéf al-AnfMuzmin
(Chronic Sinusitis). WaramTajäwéf al-AnfMuzminis called chronic
sinusitis in modern medicine, which is a chronic inflammatory condition of
upper respiratory tract involving the paranasal sinuses. It is usually followed
by coryza and cold or sometimes is caused by dental infection, deeply seated in
upper jaw. Most of the times, the maxillary sinuses are involved. However, it
may also affect other sinuses on one or both sides.(5,6,7)Chronic
sinusitis is characterized by symptoms of sinusinflammation lasting more than
12 weeks. This illness is mostcommonly associated with either bacteria or
fungi, and clinicalcure in most cases is very difficult.28 In this stage, the
damageto the mucus membrane occurs which leads to the impairmentof the ciliary
activity and thickening of mucus membrane. Thiscondition may progress until the
sinus is filled with polypi andpus, which is discharged at frequent intervals
into the nose.Symptoms are varied and complaint may be of frequent colds,or an
unpleasant taste or a bad smell in the nose. The discharge is frequently foul.
As the condition settles into the chronic stage, pain and tenderness disappear
The treatment of choice for chronic sinusitis in conventional medicine is nasal
or oral corticosteroids, antibiotics, nasal sprays, decongestants. The drugs
are associated with various side effects like nose bleeds, stinging sensation
in the throat and nose, in rare cases nasal perforation can also occur due to
use of nasal corticosteroids. Therefore a polyherbal formulation comprising of Pudina
(Menthaspicata L.), Ajwain(PtychotisAjowan), Ustukhudus (Prunella
Vulgaris), Marzanjosh (OriganumMajorana) and Guletesu (Butea
Frondosa) will be given as inhalation or Shamoom to the patients and
efficacy will be tested.
Study design: Open
observational study.
Sample size: 20 patients.
Intervention.
Test
drugs:Pudina, Ajwain, Ustukhuddus, Marzanjosh, GuleTesu.
Method of
Prepration:
Dosage: 5 gm of each drug taken in 200ml of water and boiled and shamoom
or inhalation taken daily at bed time for ten minutes.
Route of Administration: Inhalation
Duration of Protocol: 45 days with
follow up as ( 15th, 30th,45th)
Duration of Study: 2 years
Procedure of study:
Enrolled cases
of Sinusitis will be taken, after obtaining a written informed consent. The
patients will be treated with test drugs and pre and post treatment subjective
and objective findings (effects) will be compared and its significance will be
evaluated through a suitable statistical test.
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